Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
Phase: NA
Conditions: Aortic Valve Stenosis
Sponsor: Abbott Medical Devices

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 1 of 211 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial 
(PORTICO)  
NCT02000115 
 
Clinical Investigation Plan (CIP): CL06799 
 
 
Investigational Devices 
Description: St. Jude Medical (SJM) Portico™ Transcatheter Aortic Valve 
Trade Name: Portico™ Transcatheter Heart Valve: 
Portico 23mm valve 
Portico 25mm valve 
Portico 27mm valve 
Portico 29mm valve 
Model Numbers: PRT-23-IDE or PRT-23 
PRT-25-IDE or PRT-25 
PRT-27-IDE 
PRT-29-IDE 
(or equivalent model numbers in respective geographies) 
Associated Investigation Devices: Portico   Delivery Systems 
FlexNav Delivery Systems 
Portico Loading Systems 
FlexNav Loading Systems 
Model Numbers: PRT-DS-TF-18F-IDE, PRT-DS-TF-19F-IDE 
PRT-DS-ALT-18F-IDE, PRT-DS-ALT-19F-IDE 
PRT-LS-TFALT-18FID, PRT-LS-TFALT-19FID 
FN-DS-SM-IDE, FN-DS-LG-IDE, FN-LS-SM-IDE, FN-LS-LG-
IDE(or equivalent model numbers in respective 
geographies) 
Study Sponsor 
St. Jude Medical (now Abbott) 
Attn: Global Clinical Affairs, PORTICO Clinical Study 
5050 Nathan Lane North 
Plymouth, MN 55442 USA 
Tel (651) 756-5400 
National Co-Principal Investigators 
Dr. Greg Fontana, MD (Cardiac Surgeon) 
Los Robles Hospital and Medical Center 
215 West Janss Road 
Thousand Oaks, CA  91360 
(805) 497-2727 
 
 
Dr. Raj Makkar, MD (Interventional Cardiologist) 
Cedars-Sinai Medical Center 
8700 Beverly Blvd. 
Los Angeles, CA 90048 
(310) 423-3977 (Office) 
Document Version 
Version: L 
Date:  August 8, 2018 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 2 of 211 
 
Study Title:  
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial 
(PORTICO) 
 
CIP Number: CL06799 
 
Study Device: Portico™ Transcatheter Heart Valve and Delivery Systems 
 
 
 
 
 
I, the undersigned, have read and understand the Clinical Investigation Plan specified above 
and agree to follow its content. 
 
 
 
 
 
 
 
____________________________________ 
Site Principal Investigator Name (please print) 
 
 
 
____________________________________                          ________________ 
Site Principal Investigator Signature  
 
 
  Date 
 
 
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 3 of 211 
Table of Contents 
 
1 
PURPOSE (PIVOTAL IDE AND CONTINUED ACCESS PROTOCOL (CAP)) .................................................... 7 
1.1 
INDICATION FOR USE ......................................................................................................................................7 
1.2 
STUDY DESIGN AND OBJECTIVES .......................................................................................................................7 
1.2.1 
Study Design and Objectives (Pivotal IDE) ......................................................................................7 
1.2.2 
Study Design and Objectives (CAP) .................................................................................................8 
1.3 
STUDY ENDPOINTS (PIVOTAL IDE AND CAP) ......................................................................................................9 
1.3.1 
Pivotal IDE Endpoints (Randomized Cohort and Registries)............................................................9 
1.3.2 
Pivotal IDE FlexNav™ Study Endpoints ..........................................................................................10 
1.3.3 
CAP Endpoints ...............................................................................................................................11 
1.4 
SAMPLE SIZE AND DURATION OF THE INVESTIGATION (PIVOTAL IDE AND CAP) .......................................................11 
1.4.1 
Sample Size (Pivotal IDE) ...............................................................................................................11 
1.4.2 
Duration of the Investigation (Pivotal IDE) ...................................................................................12 
1.4.3 
Sample Size (CAP)..........................................................................................................................12 
1.4.4 
Duration of the Investigation (CAP) ..............................................................................................12 
2 
CLINICAL PROTOCOL (PIVOTAL IDE) ..................................................................................................... 12 
2.1 
BACKGROUND INFORMATION ........................................................................................................................12 
2.1.1 
Disease State and Patient Population ...........................................................................................12 
2.1.2 
Therapy for Severe Aortic Stenosis ................................................................................................14 
2.1.3 
Transcatheter Aortic Valve Replacement......................................................................................14 
2.1.4 
Status of TAVR in the United States ..............................................................................................14 
2.1.5 
Valve-in-Valve ...............................................................................................................................15 
2.1.6 
Updated Literature Search ............................................................................................................15 
2.1.7 
Results of Literature Search ..........................................................................................................15 
2.1.8 
Primary Effectiveness Endpoint ....................................................................................................16 
2.1.9 
Primary Safety Endpoint ...............................................................................................................16 
2.2 
SUMMARY OF ST. JUDE MEDICAL PORTICO TRANSCATHETER VALVE CLINICAL EXPERIENCE ........................................17 
2.3 
RATIONALE (PIVOTAL IDE AND CAP) ..............................................................................................................20 
2.3.1 
Pivotal IDE Rationale .....................................................................................................................20 
2.3.2 
CAP Rationale ...............................................................................................................................20 
2.4 
NAME AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE (PIVOTAL IDE AND CAP) ..............................................21 
3 
PORTICO TRANSCATHETER AORTIC HEART VALVE ............................................................................... 22 
3.1 
PORTICO DELIVERY SYSTEMS .........................................................................................................................23 
3.1.1 
First-Generation Portico Delivery System .....................................................................................23 
3.1.2 
Second-Generation FlexNav™ Delivery System .............................................................................24 
3.2 
PORTICO INSTRUCTIONS FOR USE ...................................................................................................................26 
4 
RISK AND BENEFITS OF THE STUDY DEVICE AND CLINICAL STUDY (PIVOTAL IDE AND CAP) ................. 26 
4.1 
RISKS ........................................................................................................................................................27 
4.2 
GENDER-BASED RISKS ..................................................................................................................................29 
4.3 
RISK MINIMIZATION.....................................................................................................................................29 
4.4 
BENEFITS ...................................................................................................................................................30 
5 
STUDY POPULATION (PIVOTAL IDE AND CAP) ...................................................................................... 30 
5.1 
INCLUSION CRITERIA ....................................................................................................................................31 
5.2 
EXCLUSION CRITERIA ....................................................................................................................................33 
5.3 
SCREENING PROCESS ....................................................................................................................................34 
5.3.1 
Additional Exclusion Criteria (Transcatheter Access-Related) ......................................................35 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 4 of 211 
6 
SUBJECT ASSIGNMENTS ....................................................................................................................... 38 
6.1 
HIGH RISK COHORT (PIVOTAL IDE) .................................................................................................................38 
6.2 
EXTREME RISK COHORT (PIVOTAL IDE) ...........................................................................................................38 
6.3 
VALVE-IN-VALVE REGISTRY ...........................................................................................................................39 
6.4 
ROLL-IN REGISTRY .......................................................................................................................................39 
6.5 
FLEXNAV STUDY .........................................................................................................................................40 
6.6 
CONTINUED ACCESS PROTOCOL (CAP) ............................................................................................................40 
6.7 
SCREENING ................................................................................................................................................40 
6.8 
BASELINE ASSESSMENTS ...............................................................................................................................41 
6.9 
SUBJECT ENROLLMENT AND RANDOMIZATION...................................................................................................42 
7 
STUDY CONDUCT (PIVOTAL IDE AND CAP) ........................................................................................... 44 
7.1 
SUBJECT INFORMED CONSENT .......................................................................................................................44 
7.2 
SUBJECT SELECTION COMMITTEE ....................................................................................................................44 
7.3 
INDEX PROCEDURE ......................................................................................................................................45 
7.4 
DISCHARGE VISIT (OR UP TO 7 DAYS POST PROCEDURE, WHICHEVER OCCURS FIRST) ..................................................46 
7.5 
FOLLOW-UP VISITS ......................................................................................................................................46 
7.6 
30 DAY VISIT (±7 DAYS) ...............................................................................................................................46 
7.7 
6 MONTH (±30 DAYS) (THIS VISIT IS NOT REQUIRED FOR CAP SUBJECTS ENROLLED UNDER VER. K OR LATER) ...............47 
7.8 
ONE-YEAR VISIT (-30 DAYS, + 45 DAYS) ..........................................................................................................48 
7.9 
ANNUAL VISITS (2 YEAR, 3 YEAR, 4 YEAR AND 5 YEAR (±60 DAYS)) .......................................................................48 
7.10 
UNSCHEDULED VISITS ..............................................................................................................................49 
7.10.1 
Unscheduled Visits for Evaluation of Suspected Neurological Event .......................................49 
7.11 
EVALUATION OF ISCHEMIC STROKE AND MYOCARDIAL INFARCTION ..................................................................49 
7.12 
SUBJECT WITHDRAWAL ...........................................................................................................................49 
7.13 
TABLE OF ASSESSMENTS...........................................................................................................................49 
7.14 
STUDY ACTIVITY DEFINITIONS ...................................................................................................................52 
7.15 
DETERMINATION OF THE AORTIC ANNULUS SIZE ...........................................................................................54 
7.16 
CORE LABORATORIES ...............................................................................................................................55 
7.17 
MEDICATIONS ........................................................................................................................................55 
8 
DATA COLLECTION AND MANAGEMENT (PIVOTAL IDE AND CAP) ........................................................ 56 
8.1 
SOURCE DATA AND SUBJECT FILES ..................................................................................................................56 
9 
ADVERSE EVENTS (PIVOTAL IDE AND CAP)........................................................................................... 58 
9.1 
UNANTICIPATED ADVERSE DEVICE EFFECT ........................................................................................................58 
9.2 
ANTICIPATED ADVERSE EVENTS ......................................................................................................................58 
9.3 
POTENTIAL ANTICIPATED ADVERSE EVENTS ......................................................................................................58 
9.4 
ADVERSE EVENT REPORTING .........................................................................................................................60 
9.4.1 
Reporting All Adverse Events ........................................................................................................60 
9.4.2 
Paravalvular Leak..........................................................................................................................60 
9.4.3 
Reporting Unanticipated Adverse Device Effects ..........................................................................60 
9.5 
CLASSIFICATION OF CAUSAL RELATIONSHIPS .....................................................................................................61 
9.6 
SUBJECT DEATH ..........................................................................................................................................61 
10 
INDEPENDENT BOARDS (PIVOTAL IDE AND CAP) ................................................................................. 61 
10.1 
CLINICAL EVENTS COMMITTEE...................................................................................................................61 
10.2 
DATA SAFETY MONITORING BOARD (DSMB) (PIVOTAL IDE) .........................................................................62 
11 
STATISTICAL METHODS AND ANALYSIS (PIVOTAL IDE) ......................................................................... 62 
11.1 
ANALYSIS POPULATIONS ..........................................................................................................................62 
11.2 
RANDOMIZATION AND STRATIFICATION .......................................................................................................63 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 5 of 211 
11.3 
PRIMARY ENDPOINTS ..............................................................................................................................63 
11.3.1 
Primary Effectiveness Endpoint ................................................................................................63 
11.3.2 
Primary Safety Endpoint...........................................................................................................65 
11.4 
SAMPLE SIZE CALCULATIONS .....................................................................................................................66 
11.4.1 
Sample Size for the Primary Effectiveness Endpoint ................................................................67 
11.4.2 
Sample Size for the Primary Safety Endpoint ...........................................................................68 
11.4.3 
Total Sample Size .....................................................................................................................68 
11.5 
SECONDARY ENDPOINTS ..........................................................................................................................68 
11.6 
MULTIPLICITY ADJUSTMENT......................................................................................................................70 
11.7 
ADDITIONAL ANALYSIS .............................................................................................................................70 
11.7.1 
Subgroup Analysis: Sex/gender ................................................................................................70 
11.7.2 
Additional Analyses of Primary Effectiveness Endpoint ...........................................................71 
11.7.3 
Additional Analyses of Primary Safety Endpoint ......................................................................71 
11.7.4 
Analysis of Descriptive Endpoints .............................................................................................72 
11.8 
POOLING ANALYSIS .................................................................................................................................72 
11.9 
ADDITIONAL ASSESSMENT ........................................................................................................................72 
11.10 
STATISTICAL METHODS AND ANALYSIS (FLEXNAV STUDY, REGISTRIES AND CAP) ................................................73 
12 
STUDY TERMINATION/WITHDRAWAL (PIVOTAL IDE AND CAP) ........................................................... 73 
13 
STUDY MANAGEMENT (PIVOTAL IDE AND CAP) .................................................................................. 75 
13.1 
STUDY INVESTIGATORS ............................................................................................................................76 
13.2 
NATIONAL PRINCIPAL INVESTIGATORS .........................................................................................................76 
13.3 
INVESTIGATOR RESPONSIBILITIES................................................................................................................76 
13.4 
REPORTS ...............................................................................................................................................77 
13.5 
RECORDS ..............................................................................................................................................79 
13.6 
RECORD RETENTION ................................................................................................................................79 
13.7 
CONFIDENTIALITY ...................................................................................................................................80 
13.8 
AMENDMENT PROCEDURE .......................................................................................................................81 
13.9 
ETHICAL BASIS .......................................................................................................................................82 
13.10 
INSURANCE............................................................................................................................................82 
13.11 
SUBPOPULATIONS ...................................................................................................................................82 
13.12 
UNDERREPRESENTED GROUP CONSIDERATIONS ............................................................................................83 
13.13 
STUDY MONITORING ...............................................................................................................................83 
13.14 
REGULATORY INSPECTIONS .......................................................................................................................83 
13.15 
COMPLIANCE .........................................................................................................................................84 
13.16 
PROTOCOL DEVIATION .............................................................................................................................84 
13.17 
DEVICE ACCOUNTABILITY .........................................................................................................................85 
13.18 
ECONOMIC AND QUALITY OF LIFE ANALYSIS .................................................................................................85 
13.19 
PUBLICATIONS .......................................................................................................................................85 
13.20 
INVESTIGATIONAL SITE START-UP ...............................................................................................................85 
13.20.1 
Study Initiation Visit .................................................................................................................85 
13.20.2 
Site Activation ..........................................................................................................................86 
14 
SPONSOR CONTACT INFORMATION..................................................................................................... 86 
15 
BIBLIOGRAPHY..................................................................................................................................... 87 
16 
APPENDICES ........................................................................................................................................ 91 
 
 
 
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 6 of 211 
List of Tables 
TABLE 1. CLASSIFICATION OF SEVERITY OF AORTIC VALVE DISEASE IN ADULTS .........................................................................13 
TABLE 2. MEAN CUMULATIVE RATES OF EFFECTIVENESS ENDPOINTS ...................................................................................16 
TABLE 3. MEAN CUMULATIVE RATES OF SAFETY ENDPOINTS ACROSS STUDIES ......................................................................16 
TABLE 4. PORTICO TRANSFEMORAL VALVE CLINICAL EVALUATION SERIES .............................................................................18 
TABLE 5. PRIMARY ENDPOINTS AND OBJECTIVES FOR PORTICO VALVE EVALUATIONS ..............................................................19 
TABLE 6. SUMMARY OF PORTICO TF VALVE EVALUATIONS AT 30 DAYS ...............................................................................20 
TABLE 7. VALVE MODEL NUMBER AND REFERENCE DIMENSIONS ........................................................................................21 
TABLE 8. DELIVERY AND LOADING SYSTEMS AND MODEL NUMBERS ....................................................................................22 
TABLE 9. TABLE OF ASSESSMENTS (IDE PIVOTAL TRIAL AND CAP) ......................................................................................50 
TABLE 10. STUDY ACTIVITY DEFINITIONS ........................................................................................................................52 
TABLE 11. SCHEDULE OF DATA COLLECTION (CASE REPORT FORMS) ...................................................................................57 
TABLE 12. REPORTING OBLIGATIONS.............................................................................................................................78 
 
List of Figures 
FIGURE 1: PORTICO US PIVOTAL IDE TRIAL ...................................................................................................................8 
FIGURE 2. PORTICO TRANSCATHETER HEART VALVE .........................................................................................................23 
FIGURE 3. FIRST-GENERATION PORTICO DELIVERY SYSTEM (DEPLOYMENT END) ....................................................................23 
FIGURE 4. FIRST-GENERATION PORTICO DELIVERY SYSTEM ................................................................................................24 
FIGURE 5: SECOND-GENERATION FLEXNAV™ DELIVERY SYSTEM HANDLE DETAIL ..................................................................25 
FIGURE 6: SECOND- GENERATION FLEXNAV™ DELIVERY SYSTEM (PROXIMAL END) ................................................................26 
FIGURE 7: STUDY CONDUCT FLOWCHART (PIVOTAL IDE AND CAP) ....................................................................................37 
FIGURE 8. HIGH RISK COHORT FLOW CHART...................................................................................................................38 
FIGURE 9. EXTREME RISK COHORT FLOW CHART .............................................................................................................39 
FIGURE 10. PORTICO CLINICAL STUDY FLOW CHART ......................................................................................................43 
 
List of Appendices 
APPENDIX A: ABBREVIATIONS ......................................................................................................................................91 
APPENDIX B: SYNOPSIS (PIVOTAL IDE) ..........................................................................................................................94 
APPENDIX C: DEFINITIONS ...........................................................................................................................................97 
APPENDIX D: SURGICAL RISK ASSESSMENT TOOLS......................................................................................................... 102 
APPENDIX E: QUALITY OF LIFE – EQ-5D 3L ................................................................................................................. 103 
APPENDIX F: QUALITY OF LIFE – SF-36V2 ................................................................................................................... 105 
APPENDIX G: QUALITY OF LIFE – KANSAS CITY CARDIOMYOPATHY QUESTIONNAIRE (KCCQ) ................................................ 111 
APPENDIX H: MINI-MENTAL STATE EXAMINATION (MMSE-2) ...................................................................................... 115 
APPENDIX I: CANADIAN CARDIOVASCULAR SOCIETY GRADING OF ANGINA PECTORIS ............................................................. 119 
APPENDIX J: FRAILTY ASSESSMENT ............................................................................................................................. 120 
APPENDIX K: STRUCTURED INTERVIEW FOR THE MODIFIED RANKIN SCALE (MRS) ............................................................... 122 
APPENDIX L: EXPLANT, RETURN, AND ANALYSIS OF VALVE .............................................................................................. 123 
APPENDIX M: INSTRUCTIONS FOR PACKAGING AND RETURNING PRODUCTS TO ST. JUDE MEDICAL (NOW ABBOTT) ................... 124 
APPENDIX N: NYHA CLASSIFICATION ......................................................................................................................... 125 
APPENDIX O: ATS GUIDELINES FOR THE SIX MINUTE WALK TEST .................................................................................... 126 
APPENDIX P: BARTHEL INDEX .................................................................................................................................... 130 
APPENDIX Q: PATIENT INFORMED CONSENT ................................................................................................................ 132 
APPENDIX R: LIST OF INVESTIGATIONAL SITES IN THE STUDY ............................................................................................ 152 
APPENDIX S: TAVR LEAFLET MOTION SUB-STUDY ........................................................................................................ 161 
APPENDIX T: PRINCIPAL CONTACTS ............................................................................................................................ 166 
APPENDIX U: NIH STROKE SCALE (NIHSS) ................................................................................................................. 168 
APPENDIX V: PORTICO CONTINUED ACCESS PROTOCOL (CAP) SYNOPSIS .......................................................................... 176 
APPENDIX W: PORTICO IDE FLEXNAV STUDY SYNOPSIS ................................................................................................. 181 
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 7 of 211 
1 
Purpose (Pivotal IDE and Continued Access Protocol (CAP)) 
1.1 
Indication for Use 
The Portico™ Transcatheter Aortic Heart Valve is indicated for patients with symptomatic 
severe native aortic stenosis, who are considered high or extreme surgical risk. 
 
1.2 
Study Design and Objectives  
The PORTICO clinical study is an investigational device exemption (IDE) study comprised of 
the PORTICO pivotal IDE trial (pivotal IDE) and the PORTICO IDE Continued Access Protocol 
(CAP) study.  The study design and objectives of these two separate study arms within the 
PORTICO clinical study are described below.  
 
1.2.1 Study Design and Objectives (Pivotal IDE) 
The PORTICO pivotal IDE trial is a prospective, multi-center, randomized, controlled clinical 
investigation study designed to evaluate the safety and effectiveness of the SJM Portico 
Transcatheter Heart Valve and Delivery Systems (Portico) via transfemoral and alternative 
delivery methods in high-risk and extreme-risk patients. 
As shown in Figure 1, the pivotal IDE trial includes a randomized cohort of 750 patients that 
will be used to support a Premarket Approval (PMA) application for the Portico™ 
Transcatheter Aortic Heart Valve in the United States. Prior to randomization, patients will 
be classified as high or extreme risk and stratified by vascular access within each risk group.  
At the time of the primary analysis, the risk cohorts will be combined.    
There are two nested-registries within the pivotal IDE trial (Roll-in registry and Valve-in-
Valve registry). Data from the IDE Valve-in-Valve registry will be used to support an 
expanded indication for transcatheter delivery of the Portico valve in a failed surgical 
bioprosthesis (TAVR-in-SAVR). Previous versions of the protocol included an IDE Portico 
Extreme Risk registry arm. However, enrollment in this arm has been closed since protocol 
version F, 21 May 2015.  
As part of the latest protocol update (version L), an additional study arm (“FlexNav study” or 
“FlexNav cohort”) has been added to the pivotal IDE trial. The objective of the FlexNav study 
is to characterize the safety of the second-generation Portico Delivery System (“FlexNav™ 
Delivery System”). Thirty-day outcomes data from the FlexNav study will be used to support 
the PMA application for the Portico™ Transcatheter Aortic Heart Valve and the FlexNav™ 
Delivery System. A synopsis of the FlexNav study which includes details such as objectives, 
endpoints, and other study information is provided in Appendix W.  
This protocol conforms to all the standards of Medicare coverage requirements.  The 
PORTICO subject characteristics are consistent with Medicare population and the results are 
expected to be generalizable to the Medicare population. 
Investigators enrolling subjects in the pivotal IDE trial under protocol version L or later will 
implant the Portico valve using the FlexNav™ Delivery System across all active study arms.  

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 8 of 211 
 
Portico US Pivotal IDE Trial
Roll-in Registry
Valve-in-Valve 
Registry
(Max N=100)
Portico Extreme Registry
N=13
Closed
Transfemoral (TF)
Alternative Access (AA)
Portico
Commercially 
Available Valve
Portico
Commercially 
Available Valve
Randomized
N=750 
Closed
High Risk Cohort
Extreme Risk Cohort
Transfemoral (TF)
Alternative Access (AA)
Portico
Commercially 
Available Valve
Portico
Commercially 
Available Valve
FlexNav Study
(Min N=100)
 
Figure 1: PORTICO US Pivotal IDE Trial   
 
1.2.2 Study Design and Objectives (CAP) 
The PORTICO IDE Continued Access Protocol (CAP) study is a prospective, multicenter, 
single-arm investigational study designed to collect additional safety and clinical 
effectiveness data on the SJM Portico Transcatheter Aortic Heart Valve and Delivery System 
following completion of enrollment of subjects in the randomized cohort and FlexNav study 
of the PORTICO pivotal IDE trial.  
Enrollment of the randomized cohort was completed in October 2017.Under version K of 
the protocol, subjects were enrolled into the CAP study with the first-generation Portico 
Delivery System.   The FlexNav study is expected to begin subject enrollment (under 
protocol version L) in September 2018. As sites obtain approval for protocol version L, they 
will no longer use the first-generation Portico Delivery System and CAP enrollments will be 
paused until subject enrollment closes in the FlexNav study.  Once completed, enrollment in 
the CAP will resume and all CAP subjects will have a Portico valve implanted using the 
FlexNav™ Delivery System.  
Conduct of the CAP will follow the same protocol outlined for the pivotal IDE trial except 
where indicated. The main differences between the CAP and pivotal IDE trial include:  
• A 6-month visit is not required for CAP subjects  
• CAP subjects will not be randomized. All CAP subjects will receive a Portico device.  
• The 6 Minute Walk Test (6MWT) and SF-36 questionnaire will not be required at any 
follow-up visit for CAP subjects. 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 9 of 211 
A synopsis of the CAP which includes details such as objectives, endpoints, and other study 
information are provided in Appendix V.  
Pivotal IDE sites that agree to participate in the CAP will be required to obtain IRB approval 
of Version K or later of the clinical investigational plan and corresponding informed consent.  
Portico valves used in the CAP will be the same as those used in the pivotal IDE trial . All CAP 
subjects enrolled under Version L or later of the protocol will have a Portico valve implanted 
using the FlexNav™ Delivery System. 
Subjects already enrolled under previous versions of the protocol will not be affected by this 
protocol revision as they will continue to follow the pivotal IDE or CAP follow-up 
requirements previously defined. 
 
1.3 
Study Endpoints (Pivotal IDE and CAP) 
1.3.1 Pivotal IDE Endpoints (Randomized Cohort and Registries)  
Primary Effectiveness Endpoint:  A composite of all-cause mortality or disabling stroke at 
one year. 
Primary Safety Endpoint: Non-hierarchical composite of all-cause mortality, disabling 
stroke, life threatening bleeding requiring blood transfusion, acute kidney injury requiring 
dialysis, or major vascular complications at 30 days. 
Secondary Endpoints:  
1. Severe aortic regurgitation (AR) at one year 
2. Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year 
3. Moderate or severe aortic regurgitation at one year 
4. Six-minute walk at one year 
Descriptive Endpoints:  
1. Acute device success defined as: 
o Absence of procedural mortality AND 
o Correct positioning of a single prosthetic heart valve into the proper 
anatomical location AND 
o Intended performance of the prosthetic heart valve (mean aortic valve 
gradient <20 mmHg or peak velocity <3 m/s, no moderate or severe 
prosthetic valve regurgitation) AND 
o Successful access was obtained as intended by group assignment 
2. Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year for Centers for 
Medicare and Medicaid Services (CMS) National Coverage Decision primary 
quality of life endpoint 
3. Major vascular complications at 30 days from the index procedure 
4. NYHA functional classification at 30 days, 6 months, and one year 
5. Six-minute walk test at 30 days, 6 months, and one year 
6. Paravalvular Leak (PVL) at 30 days, 6 months, and one year 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 10 of 211 
7. Aortic insufficiency greater than trace at 30 days, 6 months, one year, and two 
years 
8. Reintervention to treat aortic insufficiency at 1 year and 2 years 
9. Permanent pacemaker insertion at 30 days from the index procedure  
10. Major bleeding at 30 days from the index procedure 
11. Acute kidney injury at 30 days from the index procedure 
12. Individual components of the primary effectiveness endpoint 
o All-cause mortality at 30 days, 6 months, one year and two years 
o Disabling stroke at 30 days, 6 months, one year and two years 
13. Non-disabling Stroke and Transient Ischemic Attack (TIA) at 30 days, 6 months, 
one year, and two years 
14. Atrial fibrillation at one year and two years 
15. Quality of Life (QOL) from baseline to 30 days, 6 months and one year 
 
1.3.2 Pivotal IDE FlexNav™ Study Endpoints   
Primary Safety Endpoint:  VARC II defined major vascular complication rate at 30 days.  
 
Descriptive Endpoints:  
1. Non-hierarchical composite of all-cause mortality, disabling stroke, life 
threatening bleeding requiring blood transfusion, acute kidney injury 
requiring dialysis, or major vascular complications at 30 days from the index 
procedure 
2. All-cause mortality at 30 days and one year from the index procedure 
3. Disabling stroke at 30 days and one year from the index procedure 
4. Non-disabling stroke at 30 days from the index procedure 
5. Life threatening bleeding requiring blood transfusion at 30 days from the 
index procedure 
6. Major bleeding at 30 days from the index procedure 
7. Acute kidney injury at 30 days from the index procedure 
8. Minor vascular complication rates at 30 days from the index procedure 
9. Permanent pacemaker insertion at 30 days from the index procedure 
10. Paravalvular Leak (PVL) at 30 days from the index procedure 
11. NYHA functional classification at 30 days from the index procedure 
12. KCCQ Quality of Life (QoL) score from baseline to 30 days from the index 
procedure 
13. Technical device success defined as successful vascular access, delivery and 
deployment of the Portico Valve; retrieval with the delivery system and 
correct positioning of a single valve in the proper anatomical location 
14. Composite of all-cause mortality or disabling stroke at one year from the 
index procedure  
 
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 11 of 211 
1.3.3 CAP Endpoints 
Primary Safety Endpoint: A composite of VARC II defined all-cause mortality or disabling 
stroke at 30 days. 
 
Descriptive Endpoints:  
1. Technical device success defined as successful vascular access, delivery and 
deployment of the Portico Valve; retrieval with the delivery system and correct 
positioning of a single valve in the proper anatomical location 
2. Life threatening bleeding requiring blood transfusion and major bleeding at 30 
days from the index procedure 
3. Acute kidney injury at 30 days from the index procedure 
4. Major and minor vascular access complication rate at 30 days from the index 
procedure 
5. Permanent pacemaker insertion at 30 days from the index procedure  
6. Paravalvular Leak (PVL) at 30 days and one year from the index procedure 
7. NYHA functional classification at 30 days and one year from the index procedure 
8. Disabling stroke at 30 days and one year from the index procedure 
9. All-cause mortality at 30 days and one year from the index procedure 
10. KCCQ Quality of Life (QOL) score from baseline to 30 days and one year from the 
index procedure 
 
1.4 
Sample Size and Duration of the Investigation (Pivotal IDE and CAP) 
1.4.1 Sample Size (Pivotal IDE) 
The PORTICO pivotal IDE trial will include approximately 758 randomized subjects at up to 
70 investigational sites globally. The study is powered to analyze the high-risk cohort and 
extreme-risk cohort together against a commercially-available control for the primary safety 
and effectiveness endpoints. In addition, data for each cohort will be analyzed separately in 
a subgroup analysis.  
A minimum of two (2) and up to three (3) roll-in patients per primary implanting physician 
will be allowed. These roll-in subjects will be added to the IDE Roll-in Registry. In addition, 
up to 100 subjects may be enrolled in the IDE Valve-in-Valve registry.  
Implanting physicians with prior Portico experience and with a minimum of 3 implants in 
the last 6 months will not be required to include roll-in patients prior to enrolling patients in 
the randomized cohort.  
The FlexNav study will enroll up to 200 subjects; this sample size will include a minimum of 
100 analysis subjects and a maximum of 100 roll-in subjects.  
For subjects enrolled in the FlexNav study or Valve-in-Valve registry (under protocol version 
L or later), physicians implanting a Portico valve using the FlexNav™ Delivery System will be 
required to include a minimum of one (1) and up to three (3) roll-in subjects.  Roll-in 
subjects will be assigned prior to enrollment and will be added to the IDE Roll-in Registry.   

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 12 of 211 
Registry data will not be included in the randomized cohort analysis, but will be analyzed 
and presented separately. To support the PMA application, FlexNav study data will be 
summarized and descriptively compared to results in the randomized cohort of the pivotal 
IDE trial. 
The sponsor will submit a PMA clinical report that includes the randomized combined risk 
cohorts and the FlexNav study cohort as enrollment and follow-up is completed for each 
group according to the protocol. 
To ensure enrollment balance across study sites, no investigational site will enroll more 
than 20% of the maximum sample size for each cohort without the prior written approval of 
the sponsor. Subjects enrolled at investigational sites outside of the US will account for a 
maximum of 20% of the randomized cohort sample size and a maximum of 50% of the 
FlexNav study sample size.  
 
1.4.2 Duration of the Investigation (Pivotal IDE) 
Enrollment in the randomized cohort completed  approximately 42 months from the first 
enrollment. Enrollment in the FlexNav study is anticipated to be completed within 9 months 
from the first enrollment. Enrollment in the Valve-in-Valve registry is anticipated to be 
completed approximately 7 years after the first enrollment. All active subjects will continue 
to be followed for up to 5 years.  
 
1.4.3 Sample Size (CAP) 
Up to 1260 subjects may participate in the CAP. This sample size is based on the assumption 
of one enrollment per site per month for 21 months, assuming 60 sites actively participate 
in the study. This expected enrollment rate is based on the observed enrollment rate in the 
pivotal IDE trial over the last 12 months.  
 
1.4.4 Duration of the Investigation (CAP) 
The 21-month enrollment duration of the CAP is based on the 12-month follow-up 
requirement for the randomized cohort and a 9-month pre-market approval (PMA) review. 
Subjects enrolled will be followed for a minimum of one year and up to 5 years or upon 
study completion (whichever is reached first). 
 
2 
Clinical Protocol (Pivotal IDE) 
2.1 
Background Information 
2.1.1 Disease State and Patient Population 
Aortic stenosis (AS) is currently the most common valvular disease in the Western 
population1 and its prevalence tends to increase with age, being present in 4.6% of adults 
≥75 years.2 Aortic stenosis (AS) can be primarily attributed to rheumatic disease and senile 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 13 of 211 
degenerative calcification. Senile degenerative calcific AS is most common in the United 
States (U.S.) present in individuals older than 65 years. This calcification phenomenon is 
present in congenitally bicuspid or normal trileaflet valves. Calcific changes are due to an 
active disease process characterized by lipid accumulation, inflammation, and 
calcification.3,4 This calcification process eventually leads to a restricted valve leaflet motion 
with obstruction to left ventricular outflow.3-5  
Patients with AS are typically free from cardiovascular symptoms until late courses of the 
disease. However, once symptomatic, patients with severe AS have a poor prognosis, 
especially when combined with heart failure.5,7  
Despite the tendency to grade the degree of AS based on a variety of hemodynamic 
measurements and natural history, ACC/AHA guideline authors describe aortic stenosis as a 
continuum.   
The progression of AS can lead to the narrowing of aortic valve area by approximately 0.3 
cm2 per year. Also, the systolic pressure gradient across the valve can increase by as much 
as 15.19 mmHg per year. This functional deterioration of the aortic valve is more prevalent 
in the older population and usually coupled with coronary artery disease (CAD) and chronic 
renal insufficiency.8  
Severe symptomatic AS is considered Class I indication for surgery.8,20 The Joint ACC/AHA 
Task Force’s published guidelines for the management of patients with valvular heart 
disease includes classification criteria for determining the severity of aortic stenosis (Table 
1)20. 
 
Table 1. Classification of severity of aortic valve disease in adults 
Indicator  
Mild 
Moderate 
Severe 
Jet velocity (m/s) 
< 3.0 
3.0-4.0 
> 4.0 
Mean Gradient (mmHg) 
< 25 
25-40 
> 40 
Valve area (cm2) 
> 1.5 
1.0-1.5 
< 1.0 
Valve area index (cm2/m2) 
 
 
< 0.6 
 
After the onset of symptoms of angina pectoris, dyspnea, or syncope, annual mortality of 
patients with moderate-to-severe AS approaches 25%3 and average survival is only 2 to 3 
years. Other data also suggest the 2-year mortality rate can range from 44.4% for 
symptomatic AS patients9 to as high as 79%10 for predominant AS patients. Following 
symptomatic patients with severe aortic stenosis in whom operation was declined, 
O’Keefe11 reported mortality rates of 45%, 63% and 75% at 1 year, 2 year, and 3 year follow-
up, respectively. More recently, it has been established that inoperable patients with severe 
AS had a one year mortality rate of 50%.12  
Relief of aortic valve obstruction typically results in an improvement of symptoms, 
hemodynamic parameters, and global left ventricle systolic function, as well as reversal of 
left ventricular hypertrophy.13 
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 14 of 211 
2.1.2 Therapy for Severe Aortic Stenosis 
Several treatment options are available to patients with symptomatic AS including optimal 
medical treatment. Until recently, surgical aortic valve replacement (SAVR) was the only 
effective treatment in adults with severe AS.8 SAVR has been documented to significantly 
improve long-term survival in patients with AS.7,9,10  Despite these proven positive outcomes 
of SAVR, the decision on whether to undergo SAVR can be influenced by prohibitive 
operative risk.9  
Many patients with severe AS are considered high surgical risk and do not undergo SAVR 
due to severe comorbidities. Though some of these patients may be candidates for balloon 
valvuloplasty, this procedure has not offered any improvement in mortality.14 SAVR has an 
average operative mortality of 3% to 8%, however primary patient characteristics and 
comorbidities, such as age and reduced left ventricular (LV) function, are associated with 
increased mortality within that range.15-18 In addition, surgeon experience and hospital 
volume also affect outcomes with an absolute 2% lower mortality rate in the highest-
volume compared with the lowest-volume hospitals.19 
 
2.1.3 Transcatheter Aortic Valve Replacement 
A variety of conventional mechanical and bioprosthetic heart valves are readily accessible 
and commercially available in the U.S. However, some individuals are considered too high 
risk for open heart surgery, and may benefit from a less invasive procedure. With 
technological advancements, an alternative to SAVR, known as PAVR or TAVR 
(Percutaneous or Transcatheter Aortic Valve Replacement) and TAVI (Transcatheter Aortic 
Valve Implantation) has been under active investigation by a number of groups.21-28 This 
concept was first demonstrated by Andersen et al29 in 1992, who delivered a porcine 
bioprosthesis attached to a wire-based stent at various aortic sites with satisfactory 
hemodynamic results. In 2002, Cribier, et al,30reported the first successful human TAVR for 
the treatment of severe symptomatic aortic stenosis.  Several single-center trials followed 
which demonstrated that this new approach was feasible for the treatment of severe aortic 
stenosis in patients who were inoperable or at a very high risk to undergo SAVR. 
 
2.1.4 Status of TAVR in the United States 
The safety and effectiveness of TAVR has been confirmed with the recently published 
results of the Prospective, Randomized Placement of Aortic Transcatheter Valves (PARTNER) 
trial for high risk patients (Cohort A)34 and inoperable patients (Cohort B)12 (PMA # 
P100041). In 2011, with the FDA PMA approval of PARTNER Cohort A the Centers for 
Medicare and Medicaid Services (CMS) issued a coverage determination (NCD) for TAVR 
studies in the US (CAG-00430N).31 The CMS national coverage decision provides requisite 
guidance on patient selection, post market surveillance methods and further clinical 
investigations of transcatheter aortic valve technologies in the extreme risk and high risk 
patient populations. The PARTNER trial has provided definitive data confirming TAVR as an 
alternative to SAVR. TAVR was found to be non-inferior to SAVR in both Cohort A (High Risk 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 15 of 211 
patients) and Cohort B (Inoperable Risk patients) with severe aortic stenosis. When 
compared with standard therapy, TAVR significantly reduced the rates of all-cause mortality 
or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major 
strokes and major vascular events, in the inoperable patients with severe AS.31 
 
2.1.5 Valve-in-Valve 
There is a growing need for treatment options for patients with a failed bioprosthetic valve 
as the population ages, life expectancy improves, and the use of bioprosthetic valves 
increases. Operative mortality for elective redo aortic valve surgery is generally low (2% to 
7%), but it can increase to more than 30% in high-risk and non-elective patients. Because 
transcatheter aortic valve (TAV)-in-surgical aortic valve (SAV) implantation represents a 
minimally invasive alternative to conventional redo surgery, it may prove to be as safe and 
effective as a redo surgery. Prospective comparisons with a large number of patients and 
long-term follow-up are required to confirm these potential advantages. 
The most common reasons for an aortic valve implant redo, or valve-in-valve, are 1) wear and 
tear, 2) calcific degeneration, 3) pannus, 4) endocarditis, and 5) thrombus, where calcification 
and wear and tear are the most common reasons for bioprosthetic valve failure.36 
 
2.1.6 Updated Literature Search 
A comprehensive literature search was conducted to identify clinical studies on May 9, 2014 
from the last 10 years. The main search concepts were “aortic valve” OR “aortic valve 
stenosis” AND “percutaneous” OR “transcatheter” OR “transvascular” OR “transapical” AND 
“high risk” OR “extreme risk”. An internet search using Google Search was also conducted.  
The references resulting from this literature search were screened and data were extracted 
for high risk and extreme risk patients: 
• The high risk cohort is defined as subjects with severe aortic stenosis symptoms and 
deemed unsuitable for conventional aortic replacement surgery associated with high 
risk equivalent to an STS score that is > 8%. 
• Patients were considered extreme risk if two cardiac surgeons and one 
interventional cardiologist at the clinical site estimated a 50% or greater risk for 
mortality or irreversible morbidity at 30 days. 
Cumulative rates for each outcome were obtained from a pooled analysis among selected 
studies.  
 
2.1.7 Results of Literature Search 
The literature search yielded a total of 601 references. Based on the relevance of titles 
and abstracts review, 84 articles were assessed by full text review. Fifteen (15) articles 
met the eligibility criteria and were included in this review for the purpose of calculating 
the event rates for high risk and extreme risk patients. Eight (8) articles were removed 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 16 of 211 
from consideration for this literature review because of the duplication of these articles 
in the meta-analysis or small sample size. One additional data unpublished study result 
presented at international conference was included in the extreme risk patients’ cohort. 
Most of the study complications reported conformed to Valve Academic Research 
Consortium (VARC) definitions. In all studies, procedural success, post-procedural 
mortality and complications were a priori defined as primary endpoints. In addition, 
echocardiographic and clinical parameters were also collected in some of the studies 
which are of particular interest from the patients’ perspective. 
The composite safety and efficacy event rates calculation is based on approximately 
12,956 high risk patients from 2 meta-analyses, 2 registries and 1 randomized controlled 
trial (RCT), and 1228 extreme risk patients from 2 randomized and 1 non-randomized 
clinical studies.   
 
2.1.8 Primary Effectiveness Endpoint 
The efficacy assessment included composite event rate of all-cause mortality or 
disabling stroke for the valve procedure at 1-year for high risk and extreme risk patients. 
The mean cumulative rates derived from all included studies are presented below in 
Table 2. 
Table 2. Mean Cumulative Rates of Effectiveness Endpoints 
Effectiveness Endpoint 
Extreme risk (%) 
High Risk (%) 
All—cause mortality 
24.68 
22.20 
Major Stroke 
4.92 
0.70 
Composite event rate 
29.6 
22.9 
 
 
2.1.9 Primary Safety Endpoint 
The safety data of TAVI/TAVR procedures are composite rates of all-cause mortality, 
disabling stroke, life threatening bleeding, acute kidney injury requiring dialysis, or 
major vascular complications at 30 days. The mean cumulative rates from all included 
studies are presented below in Table 3. 
 
Table 3. Mean Cumulative Rates of Safety Endpoints Across Studies 
Safety Endpoint 
Extreme risk (%) 
High Risk (%) 
All—cause mortality 
  6.03 
8.28 
Major Stroke 
  3.06 
2.62 
Life threatening bleeding 
12.14 
4.24 
Vascular Complications 
11.33 
9.42 
Renal failure/Complications 
11.13 
3.03 
Composite event rate 
43.69 
27.59 
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 17 of 211 
2.2 
Summary of St. Jude Medical Portico Transcatheter Valve Clinical Experience 
In 2011, following preclinical (bench and animal studies) testing, SJM started conducting 
clinical investigations in Canada32 and Europe33. The study device includes the Portico 
transcatheter heart valve and its delivery systems.  
A series of six (6) prospective clinical evaluations have been conducted on the SJM Portico 
Transcatheter Aortic Valve System (Table 4). The objective of the collective series of 
evaluations is to establish a robust portfolio of safety and performance data on the Portico 
valve and transfemoral delivery system in patients with severe symptomatic AS, who are at 
high risk for conventional surgical aortic valve replacement. SJM purposely designed the 
series of evaluations under the following key considerations for consistency and to facilitate 
interpretation of results: 
• Ensure comparable patient cohort and outcome definitions, eligibility criteria, safety 
and effectiveness endpoints, sample size and overall methods across series 
• Include Valve Academic Research Consortium (VARC 2) definitions and standards in 
criteria and assessment methods 
• Include U.S. FDA’s current guidance regarding neurological assessment methods 
• Utilize global expert advisory committee for oversight including subject selection 
committee to confirm all subjects were appropriate candidates for transcatheter 
aortic valve placement and met the high-risk designation 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 18 of 211 
 
Table 4. Portico Transfemoral Valve Clinical Evaluation Series 
Study Series 
Sample Size 
Geography 
Status 
EU First in Human TF-23 
(Belfast) 
10 patients 
EU (1 site) 
Enrollment complete  
12 month Follow-up 
complete and results 
presented1. 
Canadian Special Access 
First in Human TF 23 
13 patients 
Canada (2 sites) 
Implants complete 
30 day results published 
on first 10 subjects2. 
Canadian Special Access 
Long Term Follow-up 
13 patients (TF) 
Canada (2 sites) 
TF 12 month follow-up 
complete. 
TF EU CE Mark Trial: 
23mm 
50 patients 
EU (5 sites) 
TF 23mm enrollment 
complete (N=50). 30 day 
and 12 month follow-up 
complete and results 
published3,4. Original CE 
Mark approval on 
November 16, 2012. 
TF EU CE Mark Trial: 
25mm 
50 patients 
EU (7 sites) 
TF 25mm enrollment 
complete (N=50).30 day 
and 12 month follow-up 
complete and results 
published3,4. Original CE 
Mark approval on 
December 11, 2013. 
TF EU CE Mark Trial: 27-
29mm 
120 patients 
EU/AUS (12 sites) 
27mm and 29mm 
enrollment complete 
(N=120).  30 day and 12 
month follow-up 
complete and results 
published3,4 .  Original 
CE Mark approval on 
September 15, 2015. 
1 Manoharan, G. Prospective, Multicenter Evaluation of the Portico Transcatheter Aortic Valve: Acute Results and one year Outcomes. 
TCT 2012. 
2 Willson, et al.  Transcatheter Aortic Valve Replacement with The St. Jude medical Portico Valve: First in Human Experience. J Am Coll 
Cardiol 2012;14:581-586. 
3 Möllmann H, Linke A, Holzhey D et al. Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the PorticoTranscatheter Aortic 
Bioprosthetic Family J Am Coll Cardiol Intv 2017;10:1538–47. 
4 Linke A, Holzhey D, Möllmann H et al. Treatment of Aortic Stenosis With a Self-Expanding, Resheathable Transcatheter Valve: One-Year 
Results of the International Multicenter Portico Transcatheter Aortic Valve Implantation System Study. Circ Cardiovasc Interv. 2018; 
11:e005206. DOI: 10.1161/CIRCINTERVENTIONS.117.005206 
 
As summarized in Table 5 below, the primary endpoints and objectives were comparable 
across all prospective clinical evaluations of the Portico device. As previously referenced, 
VARC standardized outcome definitions were routinely implemented within all of the 
Portico clinical evaluations.  

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 19 of 211 
Table 5. Primary Endpoints and Objectives for Portico Valve Evaluations 
 
European FIH (Belfast); 
N=10 
FIH Canadian Special 
Access; N=10 
Portico TF 
23mm/25mm 
CE Mark 
N=100 
Portico TF 
27mm/29mm 
CE Mark 
N=120 
Primary 
Safety 
Endpoint(s)/
Objectives 
Mortality, MI, stroke, 
bleeding, acute kidney 
injury, vascular 
complications, prosthetic 
valve performance, 
prosthetic valve 
associated complications 
Mortality, MI, stroke, 
bleeding, vascular 
complications 
All-cause mortality at 30 days 
Primary 
Efficacy 
Endpoint(s)/
Objectives 
Clinical benefit: NYHA 
functional classification 
and QoL. 
Procedural outcomes, 
delivery, deployment, 
removal, and closure 
Functional improvement from 
baseline to 30 days for NYHA 
functional classification, 6-minute 
walk test, effective orifice area (EOA) 
 
The consistent primary safety endpoint for the Portico clinical evaluation series is 30-day all-
cause mortality. St. Jude Medical follows all European CE mark study subjects to 12 months 
per clinical study protocol. SJM follows Portico subjects enrolled in the CE Mark studies for a 
minimum of 5 years post implant under a separate post-market surveillance study to assess 
long-term safety and performance outcomes, enabling the assessment of long term clinical 
durability for the valve. 
Safety and performance of these clinical series is summarized in Table 6. 
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 20 of 211 
Table 6. Summary of Portico TF Valve Evaluations at 30 Days 
Outcomes 
European 
FIH  
N=10 
Canadian 
Special Access  
N=10 
Portico TF Mark 
Study (23/25mm) 
N=103 
Portico TF CE 
Mark Study 
(23/25/27/29mm) 
N=222 
Death 
• From any cause 
• From cardiovascular 
causes 
 
0 
0 
 
0 
0 
 
3/103 (2.9%) 
3/103 (2.9%) 
 
8/222 (3.6%) 
     8/222 (3.6%) 
• Stroke 
• Disabling 
• Non-disabling 
• TIA 
0 
0 
0 
0 
0 
0 
1/10 (10%) 
0 
4/103 (3.9%) 
3/103 (2.9%) 
1/103 (1.0%) 
4/103 (3.9%) 
12/222 (5.4%) 
7/222 (3.2%) 
5/222 (2.3%) 
6/222 (2.7%) 
Death from any cause or 
stroke 
0 
0 
3/103 (2.9%) 
8/222 (3.6%) 
Myocardial Infarction (MI) 
0 
0 
2/103(1.9%) 
7/222 (3.2%) 
Vascular Complication 
• Major 
• Minor 
 
0 
0 
 
0 
1/10 (10%) 
 
6/103 (5.8%) 
4/103 (3.9%) 
 
14/222 (6.3%) 
11/222 (5.0%) 
Acute Kidney Injury 
• All  
• Stage 1 
• Stage 2 
• Stage 3 
 
0 
0 
0 
0 
 
0 
0 
0 
0 
 
8/103 (7.8%) 
3/103 (2.9%) 
3/103 (2.9%) 
2/103 (1.9%) 
 
9/222 (4.1%) 
3/222 (1.4%) 
3/222 (1.4%) 
3/222 (1.4%) 
Bleeding 
• Life threatening 
• Major 
 
0 
0 
 
0 
0 
 
4/103 (3.9%) 
11/103 (10.7%) 
 
7/222 (3.2%) 
24/222 (10.8%) 
New Pacemaker 
0 
0 
10/103 (9.7%) 
30/222 (13.5%) 
 
2.3 
Rationale (Pivotal IDE and CAP) 
2.3.1 Pivotal IDE Rationale 
The rationale for this study is to potentially offer a SJM transcatheter Portico valve that is 
safe and effective for subjects with symptomatic, severe aortic valve stenosis who are 
considered at high or extreme risk for conventional surgical aortic valve replacement.  
The rationale for conducting the FlexNav study as a separate arm of the pivotal IDE trial is to 
enable the direct comparison of 30-day safety outcomes data for the FlexNav™ Delivery 
System to the first-generation Portico Delivery System.  Results from the FlexNav study will 
be included in a PMA application to support US approval of the Portico Transcatheter Heart 
Valve and FlexNav™ Delivery System. 
 
2.3.2 CAP Rationale 
The rationale for the CAP is to allow current IDE study implanters to maintain their technical 
proficiency in Portico device implantation. Data from the CAP may be used to support the 
PMA application for the Portico™ valve system.  

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 21 of 211 
2.4 
Name and Description of the Investigational Device (Pivotal IDE and CAP) 
The investigational devices used in the PORTICO clinical study  consist of the Portico™ 
Transcatheter Aortic Heart Valve, the first-generation Portico Delivery System and the 
FlexNav™ Delivery System. 
The PORTICO clinical study is utilizing the 23mm, 25mm, 27mm and the 29mm St. Jude 
Medical Portico™ Transcatheter Aortic Heart Valve. The Portico valve will be implanted 
using the Transfemoral access (TF), or alternative access (AA) consisting of 
Subclavian/Axillary and Transaortic access. 
The Portico valve model number and reference dimensions are provided Table 7.  Model 
numbers for equivalent devices may vary based on respective geographies.  
 
Table 7. Valve Model Number and Reference Dimensions 
Model Number 
Intended to Treat Aortic Annulus Diameter 
PRT-23-IDE 
19 – 21mm 
PRT-25-IDE 
21 – 23mm 
PRT-27-IDE 
23 – 25mm 
PRT-29-IDE 
25 – 27mm 
 
The model numbers of the first-generation and second-generation (“FlexNav”) Portico 
delivery systems and loading systems associated with the Portico valve are provided in 
Table 8. Part numbers are subject to change, but SJM maintains a list, which is available 
upon request. Model numbers for equivalent delivery and loading systems may vary based 
on respective geographies.  
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 22 of 211 
Table 8. Delivery and Loading Systems and Model Numbers 
Model Number 
Delivery System Diameter 
PRT-DS-TF-18F-IDE 
18 Fr 
PRT-DS-ALT-18F-IDE 
18 Fr 
FN-DS-SM-IDE1 
18 Fr 
PRT-DS-TF-19F-IDE 
19 Fr 
PRT-DS-ALT-19F-IDE 
19 Fr 
FN-DS-LG-IDE1 
19 Fr 
PRT-LS-TFAL-18FID 
N/A (loading system) 
FN-LS-SM-IDE2 
N/A (loading system) 
PRT-LS-TFALT-19FID 
N/A (loading system) 
FN-LS-LG-IDE2 
N/A (loading system) 
1Indicates second-generation FlexNav™ Delivery System. Only allowed under protocol version L or later 
2Indicates second-generation FlexNav™ Loading System.  Only allowed under protocol version L or later  
 
3 
Portico Transcatheter Aortic Heart Valve 
The Portico Transcatheter Aortic Heart Valve (Figure 2) is designed to be implanted in the 
native aortic heart valve without open heart surgery and without concomitant surgical 
removal of the failed native valve. 
The valve stent is made from nitinol, a material that has self-expanding properties and is 
radiopaque. The valve cuff is made from porcine pericardium that is sutured to the stent 
frame.  
The cuff provides the sealing area for implantation. The valve orifice is made by suturing 
three valve leaflets, each made from a single layer of bovine pericardium, into a trileaflet 
configuration on the stent frame. The cuff and leaflet pericardial tissue is preserved and 
crosslinked in glutaraldehyde. Glutaraldehyde, formaldehyde and ethanol are used in the 
valve sterilization process. 
The valve leaflets and valve cuff are processed using Linx™ anti-calcification treatment. The 
valve is supplied sterile and non-pyrogenic. 
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 23 of 211 
 
Figure 2. Portico Transcatheter Heart Valve 
 
3.1 
Portico Delivery Systems  
3.1.1 First-Generation Portico Delivery System 
The first-generation Portico Delivery System is an over-the-wire, 0.035”-compatible system 
with an outer diameter ranging between 18 French (Fr) and 19 Fr depending on valve size. 
 
Figure 3. First-Generation Portico Delivery System (deployment end) 
 
The distal (deployment) end of the delivery system features an atraumatic radiopaque tip, a 
protective sheath, and an inner shaft (Figure 3)  
The protective sheath covers and maintains the valve in the collapsed position. The 
protective sheath features a protective sheath marker band that provides a reference point 
used to determine the extent of the valve deployment (Figure 3) Error! Reference source 
not found.). 
A handle is located on the proximal end of the delivery system (Figure 4) Error! Reference 
source not found.. The handle features a sliding mechanism, two locking buttons, a 
deployment/re-sheath wheel, and a luerlock connection. The sliding mechanism facilitates 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 24 of 211 
rapid travel of the protective sheath. The sliding mechanism is not used during the valve 
deployment process. The locking buttons control movement of the sliding mechanism and 
the deployment/re-sheath wheel. The deployment/re-sheath wheel is used during the 
implantation procedure, to adjust the protective sheath position relative to the valve. The 
luerlock connection facilitates de-airing of the delivery system.  
 
 
 
Figure 4. First-Generation Portico Delivery System 
 
The delivery system will deploy the annulus end of the valve first and allow gradual 
deployment of the valve. The position of a partially deployed valve can be evaluated, and if 
needed, the valve can be re-sheathed and re-deployed, provided the valve has not been 
fully deployed from the delivery system. The partially deployed valve may be re-sheathed at 
the implantation site. 
The first-generation Portico Delivery System model number and reference dimensions are 
provided in the Instruction For Use (IFU) of the Portico™ Transcatheter Aortic Heart Valve.  
 
3.1.2 Second-Generation FlexNav™ Delivery System  
The second-generation FlexNav™ Delivery System (“FlexNav Delivery System”) is an over-
the-wire, 0.035”- compatible system that includes a hydrophilic-coated, integrated sheath 
to facilitate gradual, controlled deployment of the valve in patients with a minimum vessel 
diameter of ≥5mm.  

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 25 of 211 
 
The FlexNav™ Delivery System allows for transfemoral, subclavian/axillary or transaortic 
access methods with the current range of Portico valves size (23, 25, 27 and 29mm). The 
FlexNav™ Delivery System has a working length of 107cm and is composed of a handle at 
the proximal end, connected to a shaft that is 13 Fr at the proximal end and 18F or 19F at 
the distal end (Figure 5). 
 
 
 
Figure 5: Second-Generation FlexNav™ Delivery System Handle Detail 
 
 
The FlexNav™ Delivery System shaft includes a stability layer over the outer member to 
improve control during positioning and deployment of the valve. The FlexNav™ Delivery 
System handle functions in a similar manner as the first-generation Portico Delivery system 
with modifications and added labeling. The macro slide that facilitates opening and closure 
of the delivery system has been moved and incorporated into the proximal end of the 
handle with two release buttons.   
The distal end of the FlexNav™ Delivery System features an atraumatic, radiopaque tip with 
hydrophilic coating and a radiopaque inner member marker band to aid in visualizing. The 
FlexNav™ delivery system includes the same retainer design as the first-generation Portico 
Delivery System (Figure 6).  
Summary of key design improvements to the FlexNav™ Delivery System: 
• Integrated sheath to allow sheathless insertion 
• Hydrophilic coating for smoother insertion and tracking to the target area  
• Stability Layer to improve valve handling and improve placement accuracy during 
deployment 
• Improved handle design to provide easier user operation 
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 26 of 211 
 
Figure 6: Second- generation FlexNav™ Delivery System (Proximal End) 
 
As with the first-generation Portico Delivery system, the FlexNav™ Delivery Systems deploys 
the annulus end of the valve first to allow gradual deployment of the valve. The position of 
a partially deployed valve can be evaluated, and if needed, the valve can be re-sheathed 
and re-deployed, provided the valve has not been fully deployed from the delivery system. 
The partially deployed valve may be re-sheathed a maximum of two times. 
 
3.2 
Portico Instructions for Use 
For instructions for use (IFU) of the Portico valve and the associated delivery and loading 
systems please refer to the following IFUs (Note: Model numbers for equivalent devices 
may vary based on respective geographies): 
• PorticoTM Transcatheter Heart Valve (Models PRT-23-IDE, PRT-25-IDE, PRT-27-IDE, 
and PRT-29-IDE) 
• PorticoTM Transfemoral Delivery Systems (Model PRT-DS-TF-18F-IDE and PRT-DS-TF-
19F-IDE) 
• PorticoTM Alternative Access Delivery Systems (Model PRT-DS-ALT-18F-IDE and PRT-
DS-ALT-19F-IDE) 
• PorticoTM Transfemoral/Alternative Access Loading Systems (Model PRT-LS-TFALT-
18FID and PRT-LS-TFALT-19FID) 
• FlexNavTM Delivery System (FN-DS-SM-IDE, FN-DS-LG-IDE)  
• FlexNavTM Loading System (FN-LS-SM-IDE, FN-LS-LG-IDE) 
 
4 
Risk and Benefits of the Study Device and Clinical Study (Pivotal IDE and CAP) 
Participation in the pivotal IDE and CAP is expected to be associated with a similar risk and 
benefits profile to other commercially-available TAVR systems.  
Please refer to the IFU of the Portico Transcatheter Aortic Heart Valve (which includes a 
description of risks and benefits), the risks listed below and to the adverse events section in 
this protocol for a list of the potential adverse events. 
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 27 of 211 
4.1 
Risks 
There are potential risks associated with the use of transcatheter procedure with the study 
valve and commercially available control transcatheter valves. The potential risks include 
but are not limited to, the following: 
• Access site complications (e.g., pain, bleeding, infection, hematoma, 
pseudoaneurysm, etc.) 
• Acute coronary obstruction 
• Acute myocardial infarction 
• Access site injury 
• Allergic reaction to antiplatelet agents, contrast medium, anesthesia, or valve 
components 
• Anaphylactic shock/toxic reaction 
• Annulus rupture 
• Aortic rupture 
• Ascending aorta trauma 
• Atrio-ventricular node block 
• AV fistula 
• Bleeding  
• Cardiac arrhythmias 
• Cardiovascular or vascular injury, such as perforation or damage (dissection) of 
vessels, ventricle, myocardium or valvular structures that may require intervention 
• Conduction system injury 
• Death 
• Endocarditis 
• Embolism: air, calcification or thrombus 
• Exercise intolerance (weakness) 
• Fever 
• Heart failure 
• Hematoma 
• Hemodynamic compromise 
• Hemolysis 
• Hemolytic anemia 
• Hemorrhage 
• Hypotension or hypertension 
• Immunological reaction 
• Infection 
• Leakage, regurgitation 
• Left ventricular failure/rupture 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 28 of 211 
• Left ventricular impairment (due to apical scar) 
• Myocardial ischemia 
• Mitral valve insufficiency 
• Multi-organ failure 
• Neurological changes including stroke/transient ischemic attack; 
• Non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, 
inappropriate sizing or positioning) 
• Pannus 
• Paravalvular leak 
• Pericardial effusion 
• Perforation of the myocardium or a blood vessel 
• Potential coronary obstruction 
• Renal failure 
• Renal insufficiency 
• Respiratory failure (shortness of breath) 
• Sepsis 
• Septal rupture 
• Stenosis (high gradient) 
• Stroke 
• Structural valve deterioration (i.e., calcification, leaflet tear) 
• Systemic peripheral ischemia 
• Tamponade 
• Valve explant 
• Valve embolization 
• Valve migration or malposition 
• Valve stenosis 
• Valve thrombosis 
• Ventricular failure (acute) 
• Ventricular rupture 
• Vessel dissection or spasm 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 29 of 211 
It is possible these complications could lead to: 
• Transfusion 
• Conversion to open surgical procedure 
• Reoperation 
• Emergent balloon valvuloplasty 
• Emergent percutaneous coronary intervention (PCI) 
• Emergent surgery (i.e., coronary artery bypass, heart valve replacement) 
• Explantation 
• Permanent disability 
• Death 
• Permanent pacemaker 
All the listed risks may include the symptoms associated with the above mentioned medical 
conditions. 
 
4.2 
Gender-Based Risks 
A TAVR literature and background information search, pertaining to sex or gender 
differences in the intended patient population, did not reveal either a gender disparity 
favoring one gender over the other, or a race or ethnic disparity. This review shows that in 
over 50 studies, the median female percentage is 52% with a maximum of 94% female 
participation.39 It is however evidenced in the literature that the risks experienced in TAVR 
can be observed in a higher rate within the female groups. The CoreValve ADVANCE40 study 
revealed that females experienced a higher rate of stroke, major vascular complications, 
and major bleeding. Similarly, Buchanan et al. (2011) concluded that female sex was a 
predictor of major vascular complications with females requiring more transfusion. No 
differences were noted amongst patients undergoing TAVI in composite safety and efficacy 
endpoints according to sex.41 Female subjects, however, had a better 1 year survival rate in 
the Sapien PARTNER trial.12,34 Also, Humphries et al. (2012) in a study of 641 consecutive 
patients (51.3% female) showed that female gender is associated with better short- and 
long-term survival after TAVR. This is also evidenced in the PARTNER 1A findings. 
 
4.3 
Risk Minimization 
To minimize potential clinical risks to subjects participating in this clinical trial:  
• This study will undergo a review and approval process by Institutional Review Boards 
(IRBs). The IRBs will also review all study-related documents such as the protocol, 
participant recruitment announcements, and informed consent forms. 
• Investigators will be carefully selected based on their knowledge of, and experience 
implanting and managing, the TAVR devices, and in accordance with the CMS NCD 
guidance. 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 30 of 211 
• Investigators will be extensively trained with regards to implantation technique of 
the Portico TAVR devices.  
• Investigators will be provided with detailed Instructions for Use as a reference. 
• The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly 
participate in the intra-operative technical aspects of TAVR. 
• The DSMB and/or CEC will have oversight throughout the clinical trial. 
• All investigational sites will have experienced and trained implanters of the 
commercially available valve (CAV). 
Further efforts will be made to minimize these risks by selecting investigators and study 
sites who meet the following criteria: 
• Careful selection of subjects through rigorous screening and carefully selected 
inclusion and exclusion criteria. Interventional cardiologists (transfemoral operators) 
are experienced and skilled in percutaneous, structural heart interventions (such as 
BAV). 
• Cardiovascular surgeons performing procedures are board certified (or equivalent) 
and have performed sufficient AVR or TAVR procedures to satisfy CMS NCD criteria.  
• Strong interdepartmental collaboration between cardiac surgery and interventional 
cardiology operators constituting a heart team: a cohesive, multi-disciplinary team 
of medical specialties to ensure optimal patient care and who have been trained in 
the use of the study valve.  
• Procedure setting to include either a hybrid catheterization/operating room suite 
and/or a fixed C-arm angiography imaging capability in the operative suite for 
quality imaging. 
 
4.4 
Benefits 
There are no guaranteed benefits from participation in this study. Implantation of the 
transcatheter heart valve in the annular position may result in one or more of the following: 
improved valvular function, acute alleviation of symptoms related to aortic stenosis, 
improved morbidity and mortality. 
Additionally, information gained from the conduct of this study may be of benefit to other 
people with the same medical condition in the future. The long-term results of using the 
study valve are not known at the present time. Alternative treatments include palliative 
medical therapy, aortic balloon valvuloplasty, transcatheter aortic valve delivery and 
surgical replacement of the aortic valve. 
 
5 
Study Population (Pivotal IDE and CAP) 
The PORTICO clinical study is limited to two subject cohorts with severe, symptomatic aortic 
stenosis who are determined to be at high or extreme operative risk for surgical aortic valve 
replacement. The operative risk determination of study candidates will be based on the 
Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Risk Calculator. Subject case review 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 31 of 211 
will be conducted by the Subject Selection Committee to determine the patient’s eligibility to 
receive Portico valve.  
These subject cohorts are defined as follows:  
 
High risk cohort: 
The high risk cohort is defined as subjects with severe aortic stenosis symptoms 
for whom conventional aortic valve replacement surgery is associated with high 
risk equivalent to an STS risk score that is ≥8%. 
 
Extreme risk cohort: 
The extreme risk cohort is defined as subjects with severe aortic stenosis 
symptoms and deemed unsuitable for conventional aortic valve replacement 
because of predicted probability of ≥50% mortality, or at risk for a serious 
irreversible complication by 30 days.  
 
The surgical risk of study candidates will be determined by the heart team's 
interventional cardiologist(s) and cardiac surgeon(s) assessments taking into 
consideration the STS Adult Cardiac Surgery Risk Calculator.35 
 
5.1 
Inclusion Criteria  
High Risk Cohort: 
All candidates for the High Risk Cohort of this study must meet all the following inclusion 
criteria: 
1. Subjects must have co-morbidities such that the surgeon and cardiologist Co-
Investigators concur that the predicted risk of operative mortality is ≥15% or a 
minimum STS score of 8%. A candidate who does not meet the STS score criteria of ≥ 
8% can be included in the study if a peer review by at least two surgeons concludes 
and documents that the patient’s predicted risk of operative mortality is ≥15%. The 
surgeon's assessment of operative comorbidities not captured by the STS score must 
be documented in the study case report form as well as in the patient medical 
record. 
2. Subject is 21 years of age or older at the time of consent.  
3. Subject has senile degenerative aortic valve stenosis with echocardiographically 
derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or 
Doppler Velocity Index <0.25 and an initial aortic valve area (AVA) of ≤ 1.0 cm2 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 32 of 211 
(indexed EOA ≤ 0.6 cm2/m2). (Qualifying AVA baseline measurement must be within 
60 days prior to informed consent).  
4. Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional 
Classification of II, III, or IV. 
5. The subject has been informed of the nature of the study, agrees to its provisions 
and has provided written informed consent as approved by the Institutional Review 
Board (IRB) of the respective clinical site. 
6. The subject and the treating physician agree that the subject will return for all 
required post-procedure follow-up visits. 
7. Subject’s aortic annulus is 19-27mm diameter as measured by CT conducted within 
12 months prior to informed consent. Note:  if CT is contraindicated and/or not 
possible to be obtained for certain subjects, a 3D echo and non-contrast CT of chest 
and abdomen/pelvis may be accepted if approved by the subject selection 
committee. 
Extreme Risk Cohort: 
All candidates for the Extreme Risk Cohort of this study must meet # 2, 3, 4, 5, 6, 7 of the 
above criteria, and 
1. The subject, after formal consults by a cardiologist and two cardiovascular surgeons 
agree that medical factors preclude operation, based on a conclusion that the 
probability of death or serious, irreversible morbidity exceeds the probability of 
meaningful improvement. Specifically, the probability of death or serious, 
irreversible morbidity should exceed 50%. The surgeons' consult notes shall specify 
the medical or anatomic factors leading to that conclusion and include a printout of 
the calculation of the STS score to additionally identify the risks in these patients. 
All Candidates: 
Additionally, all candidates for the study must meet the following inclusion criteria for the 
TAVR Leaflet Motion Sub-study, until the minimum sub-study sample size has been 
achieved, as described in Appendix S.  This sub-study is not applicable for subjects enrolled 
under protocol  Version K or later (including CAP subjects) as the minimum sub-study 
sample size has been achieved: 
Be willing and able to undergo, at both 30 days and 6 months post-implant, a Multi-Slice 
Computed Tomography (MSCT) scan (or TEE, if medically or technically contraindicated for a 
MSCT) of the heart and cardiac structures. 
 
 
 
 
 
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 33 of 211 
5.2 
Exclusion Criteria 
High and Extreme Risk Cohort: 
Candidates will be excluded from the study if any of the following conditions are 
present: 
1. Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as 
evidenced on 12 Lead ECG) within 30 days prior to index procedure. 
2. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified 
as verified by echocardiography. 
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with 
predominant aortic regurgitation 3-4+). 
4. Any percutaneous coronary or peripheral interventional procedure performed 
within 30 days prior to index procedure. 
5. Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic 
ring, severe circumferential mitral annular calcification (MAC) which is continuous 
with calcium in the LVOT, severe (greater than 3+) mitral insufficiency, or severe 
mitral stenosis with pulmonary compromise. Subjects with pre-existing surgical 
bioprosthetic aortic heart valve should be considered for the Valve-in-Valve 
registry. 
6. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 
g/dL), thrombocytopenia (platelet count <50,000 cells/mm³).  
7. History of bleeding diathesis or coagulopathy. 
8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or 
mechanical hemodynamic support. 
9. Untreated clinically significant coronary artery disease requiring revascularization. 
10. Hemodynamic instability requiring inotropic support or mechanical heart assistance. 
11. Need for emergency surgery for any reason. 
12. Hypertrophic cardiomyopathy with or without obstruction (HOCM). 
13. Severe ventricular dysfunction with LVEF <20% as measured by resting 
echocardiogram. 
14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. 
15. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure. 
16. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), 
or clopidogrel (Plavix), or sensitivity to contrast media which cannot be adequately 
premedicated. 
17. Recent (within 6 months prior to index procedure date) cerebrovascular accident 
(CVA) or a transient ischemic attack (TIA). 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 34 of 211 
18. Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring 
chronic dialysis. 
19. Life expectancy < 12 months from the time of informed consent due to non-cardiac 
co-morbid conditions. 
20. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined 
as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), 
aortic arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or 
narrowing (especially with calcification and surface irregularities) of the abdominal 
or thoracic aorta, severe “unfolding” and tortuosity of the thoracic aorta (applicable 
for transfemoral patients only). 
21. Native aortic annulus size < 19 mm or > 27 mm per the baseline diagnostic imaging. 
22. Aortic root angulation > 70° (applicable for transfemoral patients only).  
23. Currently participating in an investigational drug or device study. 
24. Active bacterial endocarditis within 6 months prior to the index procedure. 
25. Bulky calcified aortic valve leaflets in close proximity to coronary ostia. 
26. Non-calcified aortic annulus 
27. Iliofemoral vessel characteristics that would preclude safe placement of the 
introducer sheath such as severe obstructive calcification, or severe tortuosity 
(applicable for transfemoral patients only). 
5.3 
Screening Process 
At the time the patient agrees to participate after receiving information and all the patient’s 
questions have been answered satisfactorily, the study informed consent form will be 
signed. Patients who sign an informed consent form and meet all the inclusion criteria and 
none of the exclusion criteria will be reviewed and confirmed by the Subject Selection 
Committee for participation eligibility. Subject selection should take place within 30 days 
from the date the subject provided informed consent. Once the subject is selected to 
participate in the study, baseline assessments and randomization (if applicable) can be 
completed. The index procedure should take place no later than 14 calendar days from 
subject enrollment. 
Subjects who meet the subject selection criteria and are confirmed by the Subject Selection 
Committee will be assigned to cohorts based on their surgical risk level and either 
randomized into the pivotal IDE randomized cohort  or enrolled into a study-defined registry 
(Roll-in or Valve-in-Valve), the FlexNav study or the CAP. Subjects who do not meet the 
selection criteria will not be scheduled for an implant procedure and will not be considered 
enrolled into the study.  
If a subject is consented and undergoes study-specific testing (i.e., testing that would not be 
done if they were not being considered for the study) but is not enrolled in the study, the 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 35 of 211 
subject should be followed for adverse events for 30 days from informed consent and then 
withdrawn from study participation. 
For subjects consented under protocol version L or later, if a subject undergoes study-
specific testing but does not undergo a Portico implant attempt with the FlexNav™ Delivery 
System the subject will not be considered enrolled in the study and will not require any 
further follow-up.  
Figure 7 summarizes subjects’ screening and enrollment flow. 
Subject screening depends on the joint collaboration of investigators (including designated 
interventional cardiologist(s) and designated cardiac surgeon(s)) at each site. All suitable 
subjects must undergo the established institutional specific multidisciplinary team 
assessment to confirm both appropriateness for transcatheter aortic valve placement and 
high-risk designation.  Both a cardiologist investigator and a cardiac surgeon investigator 
must be involved in the subject selection and screening process. All subjects evaluated for 
severe aortic stenosis in medical and surgical departments that are high or extreme risk 
candidates for AVR should be screened for study eligibility.  
The investigators are responsible for ensuring subject eligibility. Study sites will maintain a 
log of all the screened subjects and subjects enrolled. Reasons for meeting study criteria but 
failing to be enrolled will be captured on the screening log and may be monitored by SJM. 
 
5.3.1 Additional Exclusion Criteria (Transcatheter Access-Related) 
For subjects who do not qualify for transfemoral access, the following exclusion criteria will 
be used to screen for an appropriate alternative access delivery method. 
5.3.1.1 Transaortic Subject Cohort Specific Exclusion Criteria 
1.  Subject has pre-existing patent RIMA graft that would preclude access. 
2. Subject has a hostile chest or other condition that complicates transaortic access. 
3. Subject has a porcelain aorta, defined as an extensive circumferential calcification of 
the ascending aorta that would complicate TAo access. 
For subjects enrolled under version L of the protocol, the following exclusion criteria apply 
for transaortic access using the FlexNav™ Delivery System: 
1. Subject has a distance between the annular plane and the aortic access site <7 cm 
(2.8") 
2. Subject has a distance between the annular plane and the separate introducer 
sheath distal tip <6 cm (2.4") 
5.3.1.2 Subclavian/Axillary Subject Cohort Specific Exclusion Criteria 
1. Subject’s access vessel (subclavian/axillary) diameter will not allow for introduction 
of the applicable 18 Fr or 19 Fr delivery system. 
2. Subject’s subclavian/axillary arteries have severe calcification and/or tortuosity. 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 36 of 211 
3. Subject‘s aortic root angulation is: 
• Left Subclavian/Left Axillary: >70◦ 
• Right Subclavian/Right Axillary: >30◦ 
4. Subject has a history of patent LIMA/RIMA graft that would preclude access 
For subjects enrolled under version L of the protocol, the following exclusion criteria apply 
for subclavian/axillary access using the FlexNav™ Delivery System: 
1. Subject’s access vessel (subclavian/axillary) has a distance between the annular 
plane and the integrated sheath distal tip <17 cm (6.7") 
2. Subject’s access vessel requires the delivery system to be advanced through a 
separate introducer sheath 
For selection of the appropriate alternative access method, subjects will be screened using 
the access specific exclusion criteria, and the selection of the alternative access method will 
be based on the evaluation by the site and the Subject Selection Committee.  
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 37 of 211 
Does the patient have severe 
symptomatic Aortic Stenosis 
and is deemed high or extreme 
surgical risk by the local 
hospital heart team?
STOP. The patient is not eligible 
for the study.
Did the patient sign the study 
informed consent?
STOP. Informed consent is 
required to perform study-
specific screening tests not 
already done. Otherwise patient 
cannot be screened.
Subject scheduled for TAVR 
valve within 14 days of being 
randomized?
Does the subject meet all the 
inclusion and none of the 
exclusion criteria for either risk 
cohort?
STOP. The subject is not 
eligible for the study.
No
Yes
No
Does the subject have a failed 
surgical aortic valve 
bioprosthesis and meets all 
other inclusion/exclusion 
criteria?
Consider Valve-in-Valve 
Registry participation
No
Yes
No
Does the subject still qualify to 
participate in the study after 
going through the screening  
process?
Yes
Enrollment Occurs
Subject is assigned to the 
appropriate risk cohort and 
randomized into the appropriate 
access arm
No
Did the Subject receive a TAVR 
Valve?
Conduct discharge testing and  
follow-up visits and complete 
CRFs per protocol.
Yes
Subject will be followed per 
protocol through the one-year 
visit
No
Is this a Roll-in or Valve-in-
Valve Registry, FlexNav Study  
or CAP Subject?
Yes
No
Enrollment Occurs
Subject is assigned to the Roll-
in or Valve-in-Valve Registry
Subject approved by the 
Subject Selection Committee?
STOP. The subject is not eligible 
for the study. Complete 
applicable Screening, Baseline, 
and Termination CRFs
No
Conduct discharge testing 
and  follow-up visits and 
complete CRFs per 
protocol.
Screening, Enrollment, and Registries
Randomization, Cohorts, and Follow-up
Yes
Yes
Subject scheduled for TAVR valve 
within 14 days of being assigned to a 
Registry
Did the Subject receive a 
TAVR Valve?
Subject will only be assessed for 
any adverse events through 30 
days post procedure, and then 
terminated from the study. 
If enrolled under protocol 
version L or later, the subject 
will be exited from the study 
with no further follow-up
No
   Yes     
Did the Delivery System enter 
the subject s body
Enrollment Occurs
Subject is assigned to FlexNav 
Study or the CAP
Yes
Yes
STOP. The subject is not 
eligible for the study.
No
Figure 7: Study Conduct Flowchart (Pivotal IDE and CAP) 
  
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 38 of 211 
6 
Subject Assignments 
Subjects will be assigned to one of the following cohorts: 
6.1 
High Risk Cohort (Pivotal IDE) 
High risk subjects with an annular size between 19-27mm who qualify for transfemoral 
access and have a suitable iliofemoral vasculature for both Portico valve and an FDA 
approved commercially available transcatheter valve (CAV) will be randomized into the 
transfemoral arm to receive either the Portico valve or the CAV. Subjects who do not qualify 
for the transfemoral access arm (iliofemoral vasculature is not suitable for both Portico and 
CAV) will be randomized within the alternative access arm to receive either the Portico 
valve or CAV (Figure 8 ). 
 
Appropriate Iliofemoral Access 
for Portico and CAV?
1:1 Randomization
1:1 Randomization
TF
CAV
TF 
Portico
AA
Portico
AA
CAV
High Risk Cohort
YES
NO
Subject Selection Committee Review and Approval
 
TF=Transfemoral, CAV= Commercially Available Transcatheter Valve, AA=Alternative Access 
Figure 8. High Risk Cohort Flow Chart 
 
6.2 
Extreme Risk Cohort (Pivotal IDE) 
Extreme risk subjects will be assigned to the Extreme Risk Cohort as follows: 
Extreme risk subjects with annular size between 19-27mm who qualify for transfemoral 
access and have suitable iliofemoral vasculature suitable for both Portico and CAV will be 
randomized into the transfemoral arm to receive either the Portico valve or CAV. Subjects 
who do not qualify for the transfemoral access arm (iliofemoral vasculature is not suitable 
for both Portico and CAV) will be randomized within the alternative access arm to receive 
either the Portico valve or CAV (Figure 9 ). 
 
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 39 of 211 
Extreme Risk Cohort
Appropriate Iliofemoral Access 
for Portico and CAV?
1:1 Randomization
1:1 Randomization
TF
CAV
TF
Portico
AA
Portico
AA
CAV
YES
NO
Subject Selection Committee Review and Approval
 
TF=Transfemoral, CAV= Commercially Available Transcatheter Valve, AA=Alternative Access 
Figure 9. Extreme Risk Cohort Flow Chart 
 
6.3 
Valve-in-Valve Registry  
Subjects who have documented failed aortic surgical valve prosthesis and are deemed 
eligible to receive a transcatheter Portico valve into the existing bioprosthesis will be 
considered for eligibility in the Valve-in-Valve registry. The Valve-in-Valve registry will enroll 
up to 100 qualified subjects from the pivotal IDE trial or CAP. 
Valve-in-valve registry subjects must meet all the applicable inclusion criteria and none of 
the applicable exclusion criteria for the high or extreme risk cohort (Sections 5.1 & 5.2). 
Examples of criteria that may not apply include inclusion criterion numbers 3 and 4 (the 
bioprosthetic valve may be stenotic or require replacement due to other forms of structural 
valve deterioration), and exclusion criterion numbers 2, 3, 5 (existing surgical bioprosthetic 
aortic valve), 21, and 26. If the subject has a bioprosthetic valve in another location, the 
subjects will be excluded from the PORTICO clinical study. 
Valve-in-valve subjects’ data will not be included in the randomized population nor the 
primary data analysis; however, the data will be analyzed and presented separately to 
support an expanded indication for Valve-in-Valve use (Portico-in-SAVR). 
All Valve-in-Valve subjects enrolled under protocol version L or later will have a Portico 
valve implanted using the FlexNav™ Delivery System. Implanting physicians will be required 
to have completed a minimum of one (1) roll-in subject in the FlexNav study before 
enrolling a subject in the IDE Valve-in-Valve registry.  
 
6.4 
Roll-in Registry  
Prior to enrolling subjects in the pivotal IDE randomized cohort, sites will be required to 
complete a minimum of two (2) and up to three (3) roll-in patients per primary implanting 
physician.  However, implanting physicians with prior Portico experience and with a 
minimum of 3 implants in the last 6 months will not be required to include roll-in patients.  

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 40 of 211 
For subjects enrolled under protocol version L or later, all primary implanting physicians 
irrespective of prior Portico implant experience will be required to complete a minimum of 
one (1) and up to three (3) roll-in patients using the FlexNav™ Delivery System.   
All roll-in subjects will be added to the IDE Roll-in Registry. The roll-in subjects must meet all 
the inclusion criteria and none of the exclusion criteria and be approved by the Subject 
Selection Committee. These subjects will be followed per protocol for the duration of the 
study, or until subject’s withdrawal or death.  The roll-in subjects’ data will not be included 
in the randomized population nor the primary data analysis; however, the data will be 
analyzed and presented separately. 
 
6.5 
FlexNav Study  
High and extreme risk subjects with an annular size between 19-27mm with suitable 
anatomy for transfemoral or alternative access valve implantation using the FlexNav™ 
Delivery System (minimum vessel requirement ≥ 5mm) will be enrolled in the FlexNav study.   
All FlexNav study subjects will receive a Portico device (no randomization). 
The number of roll-in patients required by a site before they can contribute to the FlexNav 
study will be at the discretion of the Sponsor.  All roll-in subjects will be designated as such 
prior to enrollment and will be added to the IDE Roll-in Registry. 
Following the successful completion of roll-in subjects, sites will enroll subjects into the 
FlexNav study. These enrolled subjects will be considered part of the ‘analysis population’.  
Analysis subject data (excluding roll-ins) will be summarized and presented separately to 
the randomized cohort in the PMA application.  
 
6.6 
Continued Access Protocol (CAP) 
After the pivotal IDE trial has met its minimum sample-size for the randomized cohort and 
the FlexNav study, sites may choose to participate in the CAP and enroll high and extreme 
risk subjects with an annular size between 19-27mm with suitable anatomy for transfemoral 
or alternative access valve implantation.  All CAP subjects will receive a Portico valve (no 
randomization). For CAP subjects enrolled under protocol version L or later, the Portico 
valve will be implanted using the FlexNav™ Delivery System. 
 
6.7 
Screening  
Data available in the patient’s medical record may be utilized to fulfill screening and 
baseline requirements and testing does not need to be repeated if performed within 60 
days prior to informed consent. Computed Tomography (CT) scan with angiography and 
coronary and aortic angiogram (with runoff if clinically indicated) may be performed within 
12 months prior to informed consent.  

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 41 of 211 
After subject informed consent is obtained, study-specific screening evaluation may be 
conducted to determine inclusion in the study. All cardiac medications and all medications 
given for cardiovascular effect may be continued at their prescribed dosages. 
1. Demographics 
2. Medical History 
3. Canadian Cardiovascular Society (CCS) Angina Scale Assessment 
4. Surgical Risk Assessment tools (STS Risk Score, and EuroSCORE II) 
5. Forced Expiratory Volume (FEV1), if clinically indicated 
6. Physical Exam 
7. Echocardiography to include comprehensive transthoracic or transesophageal 2D 
echocardiogram, including assessment of aortic valve gradients (mean and peak), 
areas, indices, degree of regurgitation, cardiac output and cardiac index, left 
ventricle systolic function (global and segmental) 
8. Lab Measurements (per Table 9, Table of Assessments) 
9. 12 Lead Electrocardiogram (ECG) 
10. Computed Tomography Scan with Angiography for chest, abdomen and pelvis: 
aortic root and valve annulus sizing, assessment of suitability of iliofemoral access, 
and determination of appropriate coaxial angles for optimizing the valve 
implantation procedure. CT scan performed up to 12 months prior to consent will 
be acceptable. 
11. 3D Transesophageal Echocardiogram (TEE) if CT is contraindicated 
12. New York Heart Association (NYHA) Functional Classification 
13. Frailty Index Assessment  
a. Katz Index of Activities of Daily Living 
b. Grip strength 
c. 15 ft. walk 
14. Coronary and aortic angiogram (arteriograms of the lower abdominal aorta to the 
femoral arteries), with runoff if clinically indicated. Coronary and aortic angio 
performed up to 12 months prior to consent will be acceptable. 
 
6.8 
Baseline Assessments  
The following baseline data will be collected for all subjects prior to the index procedure. 
1. Chest X-ray  
2. Cardiovascular medications documentation 
3. Modified Rankin Scale (mRS) 
4. NIH Stroke Scale (NIHSS) 
5. Barthel Index 
6. Quality of Life Measures (QoL) (For CAP subjects enrolled under Ver. K or later, only 
the KCCQ and EQ-5D are required.) 
7. MMSE-2:SV 
8. Six Minute Walk Test (6MWT) (Not required for CAP subjects enrolled under Ver. K 
or later) 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 42 of 211 
9. Troponin or CK/CK-MB, INR (if subject is on Coumadin or Warfarin) 
 
6.9 
Subject Enrollment and Randomization 
All subjects who meet the study eligibility requirements will be assigned into an applicable 
registry (Roll-in or Valve-in-Valve), the FlexNav study, the CAP or one of the pivotal IDE 
randomized cohorts for operability, followed by delivery method determination based on 
vascular access (Figure 10). 
Subjects will be considered enrolled into the study after completion of all of the following 
steps: 
1. Signed informed consent is obtained. 
2. Based on the screening assessments, it is determined that the subject meets all of 
the inclusion and none of the exclusion criteria. 
3. Subject is approved by the subject selection committee. 
4. The trial cohort has been determined, and understood by the subject. 
5. The subject is randomized (pivotal IDE only) or assigned to the appropriate registry 
or CAP. 
In the FlexNav study and the CAP (under protocol version L), the subject will be considered 
enrolled once steps 1-4 above are complete and when the FlexNav™ Delivery System  
enters the subjects’ body.   
For the pivotal randomized IDE cohort, the subject will be randomized based on the cohort 
assignment as follows:  
• The high risk cohort will be randomized against an FDA-approved and commercially-
available transcatheter valve on a 1:1 basis. 
• The extreme risk cohort will be randomized against an FDA-approved and 
commercially-available transcatheter valve on a 1:1 basis. 
It is strongly recommended the implant procedure take place no later than 14 calendar days 
from subject enrollment/randomization  
Once a subject is randomized in the pivotal IDE, crossover from one arm to the other is not 
allowed.  However, following randomization or enrollment in the FlexNav Study, registry or 
the CAP, those subjects who are scheduled to receive a transcatheter valve via transfemoral 
access and found not to be suitable for this delivery modality (per the heart team medical 
decision) can receive a transcatheter valve using an alternate access modality and vice 
versa. However, this will be considered a protocol deviation unless multiple access routes 
were pre-approved by the Subject Selection Committee. The rationale for this decision must 
be documented.  
In the pivotal IDE trial, when subjects are randomized to receive a CAV, the subject selection 
and procedure must follow the FDA-approved instructions for use (IFU). 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 St. Jude Medical Cardiovascular Division is now part of Abbott: All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of St. Jude Medical Cardiovascular Division. 
CL06799 Version L  
 
 
 
 
 
 
Page 43 of 211 
 
Subject Selection Committee Review and Approval
Extreme Risk Cohort
Pivotal IDE Registries
Appropriate Iliofemoral Access for Portico 
and CAV?
1:1 Randomization
1:1 Randomization
TF
CAV
TF 
Portico
Appropriate Iliofemoral Access for Portico and 
CAV?
1:1 Randomization
1:1 Randomization
TF
CAV
TF
Portico
Site Heart/Multidisciplinary team selects a study candidate
High Risk Cohort
NO
YES
NO
YES
AA
CAV
AA 
Portico
AA
CAV
AA
Portico
Roll-in
V-in-V
IDE CAP Cohort
Pivotal IDE Randomized Cohort
Pivotal IDE FlexNav Study
Roll-in
Analysis 
Population
TF=Transfemoral, CAV= FDA approved and commercially available transcatheter valve, 
AA=Alternative Access, V-in-V=Valve-in-Valve 
Figure 10. PORTICO Clinical Study Flow Chart 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 44 of 211  
7 
Study Conduct (Pivotal IDE and CAP) 
7.1 
Subject Informed Consent 
Prior to enrolling in the clinical investigation, subjects shall be fully informed of the 
details of clinical investigation participation as required by applicable regulations and 
the center’s IRB. Informed consent must be obtained from each subject prior to any 
clinical investigation participation (including the study-specific screening phase), using 
the Informed Consent Form (ICF). The ICF must be signed and dated by the subject and 
by the person obtaining the consent. 
The subject shall be provided ample time to meet with the Site Principal Investigator or 
site personnel conducting the consent, and must be given the opportunity to ask 
questions of and receive satisfactory answers.  The subject will then be allowed 
additional time, if requested, to take a copy of the informed consent form home with 
him or her to allow for additional time to thoroughly review this documentation. 
All information pertinent to the clinical investigation shall be provided in writing and in 
native, non-technical language that is understandable to the subject. 
The process of informed consent shall avoid any coercion of or undue influence of 
patients to participate, not waive or appear to waive patient’s legal rights, use language 
that is non-technical and understandable to the patient, provide ample time for the 
patient to consider participation, and include dated signatures of the patient and of the 
clinical investigator or person obtaining the consent. 
Prior to the subject signing the ICF, the Investigator or authorized delegate will fully 
explain to the subject the nature of the research, clinical investigation procedures, 
anticipated benefits, and potential risks of participation in the clinical investigation. The 
Investigator or delegate will allow adequate time for the subject to read and review the 
informed consent form and to ask questions.  
The Investigator or authorized delegate must document in the subject’s medical records 
that the subject was consented and the date on which the consent was obtained. The 
original signed informed consent form will be retained in the subject’s clinical 
investigation records. A copy of the signed informed consent form and will be provided 
to the subject and a copy placed in the subject’s medical record. 
If new information becomes available during the clinical investigation that can 
significantly affect a subject’s future health and medical care, or willingness to continue 
in the study, that information will be provided to the subject(s) in written form. 
 
7.2 
Subject Selection Committee 
The Subject Selection Committee will be responsible for ensuring all subjects’ clinical 
eligibility and technical suitability for implant according to the protocol. The composition 
and detailed process is further defined in the Subject Selection Committee Charter. 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 45 of 211  
Subject Selection Committee review and approval is required prior to enrollment of any 
subject into any randomized cohort, FlexNav study, registry or the CAP.  
 
7.3 
Index Procedure 
The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly 
participate in the intra-operative technical aspects of TAVR.  
The index procedure should occur within 14 calendar days following subject 
randomization, registry or CAP assignment. The procedure must be performed 
according to the instructions for use (IFU) for the assigned device. 
Antiplatelet/Anticoagulation and other medications should be administered per the 
standard of care. 
Cardiac enzymes must be obtained prior to the index procedure and within 
approximately 72 hours after the procedure.  
Cardiac rhythm should be monitored and recorded at the following time points: 
1. Upon crossing native valve with the guidewire 
2. Upon positioning of the guidewire 
3. Prior to valvuloplasty (if performed) 
4. Immediately post valvuloplasty (if performed)  
5. Before valve crosses the AV valve 
6.    After valve crosses the annulus 
7.    After valve is deployed in final position  
The following data should be collected pre and post implant: 
1. Aortic systolic/diastolic pressure, Mean aortic pressure, Mean AV gradient, Peak 
AV gradient 
2. Simultaneous Aortic and LV pressure measurements for valve area calculation 
3. A supra-aortic angiogram for valve performance and coronary patency 
4. Device deployment information  
5. If performed, right atrial (RA) pressure, pulmonary artery (PA) systolic/diastolic 
pressure, Mean PA pressure, pulmonary wedge pressure (PCWP) 
The activated clotting time (ACT) should be monitored and recorded on source 
documentation during the procedure and adjusted to attempt to keep the subject’s 
ACT>250 seconds.  
If an enrolled subject is not implanted with a TAVR valve, the following will apply: 
• Randomized subjects will be followed per protocol through the one-year visit, as 
part of the primary analysis intent to treat (ITT) population, and then terminated 
from the study. 
• Registry-assigned (Roll-in or Valve-in-Valve), FlexNav study and CAP subjects will 
be assessed for any adverse events through 30 days post procedure, and then 
terminated from the study.  
 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 46 of 211  
Post Procedure Activities 
1. Echocardiogram within 24-48 hours of procedure (or at discharge) 
2. Troponin, or CK / CK-MB should be collected within approximately 12-24 hours 
after procedure, 24 hours thereafter, and at approximately 72 hours after the 
procedure (or at discharge, if patient is discharged prior to 72 hours post 
procedure) 
3. BUN and Creatinine should be collected within 72 hours after index procedure 
 
7.4 
Discharge Visit (or up to 7 days post procedure, whichever occurs first) 
The discharge visit will take place at the time of hospital discharge or up to 7 days after 
the procedure, whichever occurs first. If the subject is expected to be discharged over the 
weekend, the discharge tests may be completed on the last week day prior to discharge. 
The discharge assessment will include: 
1. Physical exam 
2. CCS Status of angina 
3. Modified Rankin Scale (mRS) 
4. NIH Stroke Scale (NIHSS) 
5. Barthel Index 
6. Echocardiogram (if not performed during the post procedure testing within 24-
48 hours after procedure) 
7. 12 lead ECG (for subjects receiving a new permanent pacemaker, ECG should be 
completed showing the underlying rhythm as well as the current pacing 
programming) 
8. Cardiovascular medications documentation 
9. Adverse events assessment 
10. Lab Measurements (per Table 9, Table of Assessments) 
 
7.5 
Follow-up Visits 
Every effort should be made by the study site to have the subject return to the 
investigative center for all study visits.  If, despite all efforts, the subject is unable to 
return to the study site in-person during a follow-up window, subjects may undergo a 
remote follow-up assessment to collect applicable data.  Remote assessments should 
include all data that can be reasonably and legally collected remotely on the study 
subject.  Visits occurring at non-study sites will be limited to standard of care data 
collection.  Authorization for the release of medical records from non-study facility is the 
responsibility of the study site.  Protocol deviations will be required for all missed 
testing. 
 
7.6 
30 Day Visit (±7 days) 
The 30 Day visit will take place 30 days (±7 days) post index procedure, and will include 
the following: 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 47 of 211  
 
1. Physical exam 
2. CCS status of angina 
3. Modified Rankin Scale (mRS) 
4. NIH Stroke Scale (NIHSS) 
5. Barthel Index 
6. Echocardiography  
7. 12 lead ECG (for subjects receiving a new permanent pacemaker, ECG should be 
completed showing the underlying rhythm as well as the current pacing 
programming) 
8. Lab Measurements (per Table 9, Table of Assessments) 
9. NYHA Functional Classification 
10. Frailty Index assessment 
11. Quality of Life Measures (For CAP subjects enrolled under Ver. K or later, only the 
KCCQ and EQ-5D are required.) 
12. MMSE-2:SV 
13. Six Minute Walk Test (6MWT) (Not required for CAP subjects enrolled under Ver. 
K or later) 
14. Cardiovascular medications  
15. Adverse events assessment 
16. Multi-Slice CT (MSCT) Scan (or TEE if MSCT is medically or technically 
contraindicated), as described in Appendix S: TAVR Leaflet Motion Sub-study 
until sub-study enrollment is complete. (Not required for subjects enrolled under 
Ver. K or later) 
 
7.7 
6 Month (±30 days) (This visit is not required for CAP subjects enrolled under 
Ver. K or later) 
The following data must be collected at 6 Months post index procedure:     
1. Physical exam 
2. CCS status of angina 
3. Modified Rankin Scale (mRS) 
4. NIH Stroke Scale (NIHSS) 
5. Barthel Index 
6. Echocardiography  
7. 12 lead ECG (for subjects receiving a new permanent pacemaker, ECG should be 
completed showing the underlying rhythm as well as the current pacing 
programming) 
8. Lab Measurements (per Table 9, Table of Assessments) 
9. NYHA Functional Classification  
10. Frailty Index assessment 
11. Quality of Life Measures (QoL)  
12. MMSE-2:SV 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 48 of 211  
13. Six Minute Walk Test (6MWT)  
14. Cardiovascular medications  
15. Adverse events assessment 
Multi-Slice CT (MSCT) Scan (or TEE if MSCT is medically or technically 
contraindicated), as described in Appendix S: TAVR Leaflet Motion Sub-study 
until sub-study enrollment is complete.  
7.8 
One-Year Visit (-30 days, + 45 days) 
The following data must be collected at one-year (-30 days, + 45 days) post index 
procedure: 
1. Physical exam 
2. CCS status of angina 
3. Modified Rankin Scale (mRS) 
4. NIH Stroke Scale (NIHSS) 
5. Barthel Index 
6. Echocardiography  
7. 12 lead ECG (for subjects receiving a new permanent pacemaker, ECG should be 
completed showing the underlying rhythm as well as the current pacing 
programming) 
8. Lab Measurements (per Table 9, Table of Assessments) 
9. NYHA Functional Classification  
10. Frailty Index assessment 
11. Quality of Life Measures (QoL) (For CAP subjects enrolled under Ver. K or later, 
only the KCCQ and EQ-5D are required.) 
12. MMSE-2:SV 
13. Six Minute Walk Test (6MWT) (Not required for CAP subjects enrolled under Ver. 
K or later) 
14. Cardiovascular medications documentation 
15. Adverse events assessment 
 
7.9 
Annual Visits (2 year, 3 year, 4 year and 5 year (±60 days)) 
The following data should be collected at years 2, 3, 4 and 5 post index procedure: 
1. Physical exam 
2. CCS status of angina 
3. NYHA Functional Classification 
4. Cardiovascular medications  
5. Adverse event assessment 
6. NIH Stroke Scale (NIHSS) 
7. Modified Rankin Stroke Scale 
8. Barthel Index 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 49 of 211  
9. 12 lead ECG (for subjects receiving a new permanent pacemaker, ECG should 
be completed showing the underlying rhythm as well as the current pacing 
programming) 
10. Echocardiography 
11. Quality of Life Measures (QoL) (For CAP subjects enrolled under Ver. K or later, 
only the KCCQ and EQ-5D are required.) 
 
7.10 Unscheduled Visits 
7.10.1 Unscheduled Visits for Evaluation of Suspected Neurological Event 
If the subject experiences a neurological event (TIA, stroke, or encephalopathy), the 
event should be documented on an adverse event form and further evaluation should 
be performed at an unscheduled visit 90 days (±14 days) from the date of the 
neurological event.  The unscheduled visit will include the following assessments: 
1. Neurological Assessment conducted by a neurologist or a neurology fellow 
2. NIH Stroke Scale 
3. Modified Rankin Scale (mRS) 
 
7.11 Evaluation of Ischemic Stroke and Myocardial Infarction 
All ischemic strokes and myocardial infarctions should be investigated per standard of 
care to include an assessment for leaflet motion (TEE is recommended) and evaluation 
of sources for an embolus (e.g., left atrial appendage). 
 
7.12 Subject Withdrawal  
All living and enrolled subjects are required to complete clinical follow-up. A study 
subject that has been withdrawn from the study will not be replaced. All data collected 
up to the point of their study discontinuation will be reported and included in the data 
analysis as applicable. 
If a subject cannot be reached for a follow-up visit, the investigator will complete a 
Protocol Deviation Case Report Form. The efforts undertaken to contact the subject, 
referring physicians, including internists as well as cardiologists, family members, or 
other alternate contacts should be noted in the subject’s records. These efforts should 
include at least three (3) attempts of telephone contact on separate dates, and a 
registered letter before considering the subject lost-to-follow-up.  
 
7.13 Table of Assessments 
Subject data and data collection timeline are summarized in Table 9.
                                                     
 
 FDA’s Current Thinking Regarding Neurological Assessments for Transcatheter Valve Trials (Revised: August 25, 2011) 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be reproduced in whole or in part without the express written permission of 
Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 50 of 211  
Table 9. Table of Assessments (IDE Pivotal Trial and CAP) 
 
Study Activity 
 
Visit window [days] 
Screening 
Baseline 
Procedure 
 
Discharge 
 
30 days 
[±7 days] 
6 Month 
[±30 days] 
7 
One Year1 
[-30,+45 
days] 
Annual 
Follow-up 
Up to 5 Y 
[±60 days] 
Physical Assessment and Subject Interview 
Informed Consent 
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
Physical Exam 
X 
 
 
X 
X 
X 
X 
X 
CCS Angina 
X 
 
 
X 
X 
X 
X 
X 
NYHA Classification 
X 
 
 
 
X 
X 
X 
X 
Cardiovascular Medications documentation 
 
X 
 
X 
X 
X 
X 
X 
Coronary and Aortic Angiogram (with runoff if clinically 
indicated) 
X (within 12 
months prior to 
consent) 
 
Adverse Events Assessment 
X 
X 
X 
X 
X 
X 
X 
X 
National Institute of Health Stroke Scale (NIHSS) 
 
X 
 
X 
X 
X 
X 
X 
Modified Rankin Scale (mRS) 
 
X 
 
X 
X 
X 
X 
X 
Barthel Index 
 
X 
 
X 
X 
X 
X 
X 
MMSE-2:SV 
 
X 
 
 
X 
X 
X 
 
Neurological Assessment 
A neurological assessment must be performed at  90 days (±14 days) from the date of a suspected 
neurological event 
Surgical Risk Assessment (STS, EuroSCOREII) 
X 
 
Six Minute Walk Test7 
 
X 
 
 
X 
X 
X 
 
Frailty Index (Katz Index of ADLs, Grip strength, 15 ft. walk) 
X 
 
 
 
X 
X 
X 
 
FEV1 
             X (if clinically indicated) 
Non-Invasive Tests 
12 lead Electrocardiogram (ECG)2 
X 
 
 
X 
X 
X 
X 
X 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be reproduced in whole or in part without the express written permission of 
Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 51 of 211  
Study Activity 
 
Visit window [days] 
Screening 
Baseline 
Procedure 
 
Discharge 
 
30 days 
[±7 days] 
6 Month 
[±30 days] 
7 
One Year1 
[-30,+45 
days] 
Annual 
Follow-up 
Up to 5 Y 
[±60 days] 
Cardiac rhythm monitoring 
 
X 
 
Echocardiogram  
X 
 
X  
optional 
X3 
X 
X 
X 
X 
3D Transesophageal Echocardiogram (TEE) 
X4 (if CT is 
contraindicated) 
TEE is also recommended after adverse events of ischemic stroke and myocardial 
infarction. 
CT Scan with Angiography  for chest, abdomen and pelvis 
X (within 12 
months of consent) 
 
Multi-slice CT (MSCT) Scan (or TEE if MSCT is medically or 
technically contraindicated), as described in Appendix S.8 
 
 
 
 
X 
X 
 
Chest X-Ray 
 
X 
 
Quality of Life Measures 
SF-367 
 
X 
 
 
X 
X 
X 
X 
EQ-5D 
 
X 
 
 
X 
X 
X 
X 
KCCQ 
 
X 
 
 
X 
X 
X 
X 
Lab Measurements 
CBC and Platelet count 
X 
 
 
X 
X 
X 
X 
 
BUN and Creatinine 
X 
 
X5 
X 
X 
X 
X 
 
BNP or ProBNP 
X 
 
 
 
X 
X 
X 
 
INR (if subject is on Coumadin or Warfarin) 
X 
 
 
 
X 
X 
X 
 
Troponin or  CK / CK-MB  
 
X 
X6 
X6 
X 
X 
X 
 
Albumin (for Frailty Index) 
X 
 
 
 
X 
X 
X 
 
1In the event a 12 month visit per the requirements in Section 7.8 is not completed, the site may call the subject to document survival. 
2For subjects receiving a new permanent pacemaker, ECG should be completed showing the underlying rhythm as well as the current pacing programming. 
3To be done within 24-48 hours after procedure, or as close to discharge as possible (but no more than 7 days after procedure). 
4If CT is contraindicated and/or not possible to be obtained for certain subjects, a 3D TEE and non-contrast CT of chest and abdomen/pelvis may be accepted if approved by the subject selection committee.  
5 To be collected within 72 hours before index procedure and within 72 hours after index procedure  
6To be collected within 12-24 hours after the procedure, approximately 24 hours thereafter, and at approximately 72 hours (or at discharge, if patient is discharged prior to 72 hours post procedure) to be consistent with VARC 2 
guidelines.  
7 Not required for CAP subjects enrolled under Ver. K or later. See Appendix V.  
8 Not required for subjects enrolled under Ver.K or later. TAVR Leaflet Motion Sub-study now closed 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 52 of 211  
7.14 Study Activity Definitions 
Table 10 summarizes the study activity definitions. 
 
Table 10. Study Activity Definitions 
Study Activity 
Definition 
Adverse Event 
Assessment 
All adverse events will be documented according to Adverse Events section 9. 
Lab Measurements 
 
The following lab tests will be collected at each required interval per Table 9, 
Table of Assessments: 
• 
CBC and Platelet count 
• 
BUN 
• 
Creatinine 
• 
BNP or ProBNP 
• 
INR (only if subject is taking Coumadin or Warfarin) 
• 
Albumin (for Frailty Index) 
• 
Troponin or CK / CK-MB  
Barthel Index 
A scale used to measure performance in activities of daily living (ADL).  Each 
performance item is rated on this scale with a given number of points 
assigned to each level or ranking.  It uses ten variables describing ADL and 
mobility where a higher number is associated with a greater likelihood of 
being able to live at home with a degree of independence following discharge 
from the hospital. 
Cardiac Rhythm 
Monitoring 
Assessment of heart rate, QRS and dominant rhythm pre-procedure, during 
and after the procedure. 
CCS Angina 
Canadian Cardiovascular Society grading of angina pectoris (Appendix I) 
Coronary and Aortic 
Angiogram (with runoff 
if clinically indicated) 
Coronary and aortic imaging conducted per institutional guidelines. 
CT Scan/MSCT Scan 
Computed Tomography (CT) with minimum of 64-detectors is recommended 
for image acquisition.  The complete cardiac cycle will be captured, 
encompassing both the diastolic and systolic phases of the heart (Multi-Slice). 
Scan records that leave the institution will be modified to remove subject 
identifiers. CT Scan images will be provided to a CT core lab for evaluation. 
Echocardiography 
Each site is responsible for performing the echocardiogram according to the 
Echocardiographic protocol. Echocardiogram will be provided to an   
Echocardiographic core lab for evaluation. 
12 lead 
Electrocardiogram (ECG) 
Assessment of heart rate, QRS and dominant rhythm using 12 lead ECG. 
For subjects receiving a permanent pacemaker during the study, an ECG will 
be completed showing the underlying rhythm as well as the current pacing 
programming. 
Electrocardiograms will be provided to an Electrocardiographic core lab for 
evaluation. 
FEV1 
The volume exhaled during the first second of a forced expiratory maneuver 
started from the level of total lung capacity. 
Frailty Index 
Used to assess if frailty is a high risk factor for subjects prior to enrollment.  
Informed Consent 
An IRB- and Sponsor-approved Informed Consent must be obtained before 
subject enrollment 
Medical History 
General medical history of the subject: 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 53 of 211  
• 
Previous cardiovascular operations  
• 
Coexisting cardiovascular diseases 
• 
Clinically significant peripheral vascular disease (PVD) 
• 
Previous peripheral vascular operations 
• 
Other coexisting medical conditions (e.g., diabetes, hypertension, kidney 
and lung disease, endocarditis) 
Cardiovascular 
Medications  
Only the following Cardiovascular medications will be collected at each visit: 
• 
Beta Blockers 
• 
Calcium Channel Blockers 
• 
Anticoagulants  
• 
Antiplatelet agents including Aspirin  
• 
Diuretics 
• 
Ace-Inhibitors 
• 
Angiotensin Receptor Blocker (ARBs) 
• 
Hydralazine 
• 
Antiarrhythmics 
MMSE-2:SV  
Mini Mental State Exam -2:SV is a screening tool for cognitive impairment 
Modified Rankin Stroke 
Scale* 
 
The modified Rankin Scale (mRS) is functional measurement to assess the 
degree of disability or dependence in the daily activities of people who have 
suffered a stroke. 
 
*This assessment must be completed by a rater who has a current certificate 
that demonstrates completion of an accredited training program for this 
stroke scale, or by a neurologist or neurology fellow. 
Multidisciplinary Heart 
Team 
All suitable subjects must undergo the established institutional specific 
multidisciplinary/Heart team (as defined in the CMS Decision Memo for TAVR 
(CAG-00430N) assessment to confirm both appropriateness for transcatheter 
aortic valve placement and high-risk designation.  Both co- investigators must 
be involved in the subject selection and screening process. All subjects 
evaluated for severe aortic stenosis in medical and surgical departments that 
are high or extreme risk candidates for AVR should be screened for study 
eligibility. 
Neurological Assessment 
A neurological assessment will be conducted on subjects 90 days (±14 days) 
after any neurological event (stroke, TIA, encephalopathy). The neurological 
assessment should be conducted by a neurologist or a neurology fellow and 
should include physical functioning as well as a basic neurocognitive 
evaluation to cover the major domains. 
NIH Stroke Scale** 
 
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate 
the effect of acute cerebral infarction on the levels of consciousness, 
language, neglect, visual-field loss, extraocular movement, motor strength, 
ataxia, dysarthria, and sensory loss. Certified personnel rate the subject’s 
ability to answer questions and perform activities. Ratings for each item are 
scored with 3 to 5 grades with 0 as normal, and there is an allowance for 
untestable items. The single subject assessment requires less than 10 minutes 
to complete.  
 
** National Institute of Health (NIH) Stroke Scale - All personnel conducting 
any study required NIHSS evaluations are required to have received training 
and certification per nationally accepted guidelines such as American Stroke 
Association, or American Academy of Neurology, or National Institute of 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 54 of 211  
Neurological Disorders and Stroke, or must be a neurologist or neurology 
fellow.  
NYHA Classification 
The New York Heart Association (NYHA) Functional Classification provides a 
simple way of classifying the extent of heart failure. It places subjects in one 
of four categories based on how much they are limited during physical 
activity; the limitations/symptoms are in regards to normal breathing and 
varying degrees in shortness of breath and or angina pain 
Physical Assessment 
At the baseline visit the following measurement must be assessed: 
• 
Age on consent date 
• 
Gender 
• 
Ethnicity 
• 
Height (only at baseline) 
The following measurements must be assessed at all visits: 
• 
Weight 
• 
Heart rate  
• 
Heart rhythm  
• 
General physical state   
Procedure Information 
Procedure information must be collected including: 
• 
Pre-procedure Information 
• 
Procedure Information 
• 
Post-procedure Information 
Quality of Life Measures  
EQ-5D 3L is a standardized instrument for use as a measure of health 
outcomes. The process to complete this questionnaire is indicated. 
SF-36 is a survey of subject health to determine cost-effectiveness of a health 
treatment 
KCCQ is a 23 item questionnaire that quantifies physical function, symptoms, 
social function, self-efficacy and knowledge, and quality of life 
Surgical Risk Assessment 
Surgical Risk Assessment tools consist of EuroSCORE II and STS Risk Score. 
Six Minute Walk Test 
 
The six-minute walk test (6MWT) measures the distance an individual is able 
to walk over a total of six minutes on a hard, flat surface. The goal is for the 
individual to walk as far as possible in six minutes. The individual is allowed to 
self-pace and rest as needed as they traverse back and forth along a marked 
walkway. 
Subject Selection 
Committee 
The Subject Selection Committee will be responsible for ensuring all subjects’ 
clinical eligibility and technical suitability for implant according to the 
protocol. The composition and detailed process is further defined in the 
Subject Selection Committee Charter. 
 
 
 
 
 
 
 
 
 
 
 
 
7.15 Determination of the Aortic Annulus Size  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 55 of 211  
The PORTICO clinical study requires that all annulus sizing be determined using a CT scan 
for all participants in the study. However, if CT is contraindicated and/or not possible to 
be obtained for certain subjects, a 3D echocardiogram and non-contrast CT of chest and 
abdomen/pelvis may be accepted if approved by the Subject Selection Committee. 
 
7.16 Core Laboratories 
Independent core laboratories will be utilized for evaluating CT images, ECG rhythms 
and echocardiograms for the pivotal IDE cohort.  The same core laboratories and 
processes will be used for the CT images and echocardiograms for the CAP cohort.  
Each site is responsible for performing the CT scan and echocardiogram according to the 
core laboratory imaging protocol. Also, ECG data collection and reporting must be 
completed according to the ECG core laboratory protocol. 
CT scan, echocardiography, and ECG data will be forwarded to the respective core 
laboratories for interpretation. It is the responsibility of each site to perform the local 
interpretation of the echocardiogram for clinical assessment.  
The core laboratories will not be responsible for notifying the site of any abnormal 
findings that are identified in the study. The responsibility of the core laboratories is to 
complete the data collection forms and submit these to the Sponsor. 
The core laboratories will provide the study required interpretation and documentation 
of each data submission. Data obtained from the core laboratory readings will be used for 
study purposes only and not for clinical treatment of the subject. The Sponsor will use 
only the measurements provided by the core laboratories in data analyses. If the core 
laboratory determines that the data are unreadable, the site will be responsible for having 
the subject return for another assessment. 
 
7.17 Medications 
If a subject is taking any of the following classes of cardiovascular medications, they will 
be reviewed at each applicable visit and documented on the visit CRF: 
1. Beta Blockers 
2. Calcium Channel Blockers 
3. Anticoagulants  
4. Antiplatelet agents including Aspirin  
5. Diuretics 
6. Ace-Inhibitors 
7. Angiotensin Receptor Blocker (ARBs) 
8. Hydralazine 
9. Antiarrhythmics 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 56 of 211  
8 
Data Collection and Management (Pivotal IDE and CAP) 
A study-specific Data Management Plan will be created to document measures ensuring 
data quality and completeness. All required study data will be recorded on study-
specific electronic Case Report Forms (eCRFs), as provided by SJM.  
Subject data will be collected using a web-based remote electronic data capture 
(EDC/RDC) system supported by SJM. The Investigator or his/her designee is responsible 
for timely recording of all data onto the study eCRFs. The data used to complete these 
forms has to be verified by authorized site personnel. 
If additional documentation (e.g., procedural notes, discharge summaries) is required 
for any reason (such as an adverse event) it should be appropriately redacted (e.g., 
blacked out) to remove the subject’s name and any additional identifying information, 
and the subject’s unique study ID code inserted, prior to being submitted to SJM. 
 
8.1 
Source Data and Subject Files 
The Investigator has to keep a written or electronic subject file for every subject 
participating in the clinical study. In this subject file, the available demographic and 
medical information of a subject has to be documented, in particular the following: 
1. Name 
2. Birth date 
3. Sex 
4. Height 
5. Weight 
6. Ethnicity (if available) 
7. Medical history 
8. Concomitant diseases and concomitant medications (including changes 
during the course of the study) 
9. Statement of entry into the study 
10. Study identification 
11. Date of informed consent 
12. All study visit dates 
13. Predefined performed examinations and clinical findings 
14. Observed AEs and source documents related to the AE 
15. Reason for withdrawal from the study, if applicable.  
It should be possible to verify the inclusion and exclusion criteria for the study from the 
available data in this file. 
It must be possible for the investigator to identify each subject by using this subject file.  
Additionally, any other documents with source data that were generated by technical 
equipment have to be filed. This may include 12 lead ECG recordings, X-ray films, CT 
scans and laboratory value listings, as applicable. All these documents have to bear at 
least the subject identification. The medical evaluation of such records should be 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 57 of 211  
documented as necessary. All data recorded on the eCRF must be found in the subject’s 
source data. 
 
Table 11. Schedule of Data Collection (Case Report Forms) 
Screening 
• Inclusion Exclusion 
• Screening 
Prior to subject selection 
committee review 
Randomization 
• Subject Selection Decision/Randomization 
At subject selection committee 
review/randomization 
Baseline 
• Baseline  
• Barthel Index 
• SF-36 v2 Health Survey (IDE Only) 
• KCCQ 
Prior to Index Procedure 
Procedure 
• Procedure  
• Lab Measurements Procedure 
• Device Portico Valve and Loading & Delivery 
System, OR 
• Device Commercially Available Valve 
• Healthcare Utilization/Hospitalization  
At time of Index Procedure 
Discharge 
• Discharge  
• Lab Measurements 
• Barthel Index 
At hospital discharge 
Follow-up 
• 30 Days, 6 Month (IDE Only) & Annual Follow-
Up Visit  
• Barthel Index 
• SF-36 v2 Health Survey (IDE Only) 
• KCCQ 
• 30 Day  
• 6 month (pivotal IDE trial only) 
• One year  
• Annually through year five 
Adverse Event 
• Adverse Event 
• Healthcare Utilization/Hospitalization (for 
cardiovascular event requiring treatment 
and/or is device-related) 
At the time of occurrence or 
notification of event 
Suspected 
Neurological 
Event 
• Neurological Assessment 
• Adverse Event 
A neurological assessment must 
be performed at  90 days (±14 
days) from the date of a suspected 
neurological event 
Protocol 
Deviation 
• Protocol Deviation 
At the time of occurrence or 
notification of event 
Subject 
Termination 
• Subject Termination 
 
When a subject is deemed to be 
no longer available for follow-up 
evaluation for any reason or when 
the subject completes the study 
Death 
• Adverse Event 
• Death 
• Subject Termination 
At the time of occurrence or 
notification of event 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 58 of 211  
9 
Adverse Events (Pivotal IDE and CAP) 
9.1 
Unanticipated Adverse Device Effect 
Any serious adverse effect on health or safety or any life-threatening problem or death 
caused by, or associated with a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the investigational 
plan or application, including a supplementary plan or application, or any other 
unanticipated serious problem associated with the device that relates to the rights, 
safety, or welfare of subjects (21 CFR 812.3 (s)). 
 
9.2 
Anticipated Adverse Events 
Adverse Events will be classified as either a Serious Adverse Event or an Adverse Event. 
Serious Adverse Event- is defined as those adverse events resulting in the following: 
death, life-threatening adverse event, unplanned inpatient hospitalization or 
prolongation of existing hospital stay, persistent or significant disability/incapacity, 
congenital anomaly/birth defect or medically significant event. 
Adverse Event - is defined as an event which does not meet the definition of a serious 
adverse event but is still an undesirable clinical occurrence and is a negative change 
from baseline, whether or not device related 
 
 
9.3 
Potential Anticipated Adverse Events 
The potential anticipated adverse events include but are not limited to, the following: 
1. Access site complications (e.g., pain, bleeding, infection, hematoma, 
pseudoaneurysm, etc.) 
2. Acute coronary obstruction 
3. Acute myocardial infarction 
4. Access site injury 
5. Allergic reaction to antiplatelet agents, contrast medium, anesthesia, or valve 
components 
6. Anaphylactic shock/toxic reaction 
7. Annulus rupture 
8. Aortic rupture 
9. Ascending aorta trauma 
10. Atrio-ventricular node block 
11. AV fistula 
12. Bleeding  
13. Cardiac arrhythmias 
14. Cardiovascular or vascular injury, such as perforation or damage (dissection) of 
vessels, ventricle, myocardium or valvular structures that may require intervention 
15. Conduction system injury 
16. Death 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 59 of 211  
17. Endocarditis 
18. Embolism: air, calcification or thrombus 
19. Exercise intolerance (weakness) 
20. Fever 
21. Heart failure 
22. Hematoma 
23. Hemodynamic compromise 
24. Hemolysis 
25. Hemolytic anemia 
26. Hemorrhage 
27. Hypotension or hypertension 
28. Immunological reaction 
29. Infection 
30. Leakage, regurgitation 
31. Left ventricular failure/rupture 
32. Left ventricular impairment (due to apical scar) 
33. Myocardial ischemia 
34. Mitral valve insufficiency 
35. Multi-organ failure 
36. Neurological changes including stroke/transient ischemic attack; 
37. Non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, 
inappropriate sizing or positioning) 
38. Pannus 
39. Paravalvular leak 
40. Pericardial effusion 
41. Perforation of the myocardium or a blood vessel 
42. Potential coronary obstruction 
43. Renal failure 
44. Renal insufficiency 
45. Respiratory failure (shortness of breath) 
46. Sepsis 
47. Septal rupture 
48. Stenosis (high gradient) 
49. Stroke 
50. Structural valve deterioration (i.e., calcification, leaflet tear) 
51. Systemic peripheral ischemia 
52. Tamponade 
53. Valve explant 
54. Valve embolization 
55. Valve migration or malposition 
56. Valve stenosis 
57. Valve thrombosis 
58. Ventricular failure (acute) 
59. Ventricular rupture 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 60 of 211  
60. Vessel dissection or spasm 
 
It is possible these complications could lead to: 
1. Transfusion 
2. Conversion to open surgical procedure 
3. Reoperation 
4. Emergent balloon valvuloplasty 
5. Emergent percutaneous coronary intervention (PCI) 
6. Emergent surgery (i.e., coronary artery bypass, heart valve replacement) 
7. Explantation 
8. Permanent disability 
9. Death 
10. Permanent pacemaker 
There are no known interactions of the Portico Transcatheter Heart Valve with 
concomitant medical treatment.  
Subjects experiencing an adverse event shall be treated per the standard of care at the 
investigation site. 
 
9.4 
Adverse Event Reporting  
9.4.1 Reporting All Adverse Events 
Investigators are responsible for promptly reporting ALL adverse events to SJM by 
completing the Adverse Event eCRF.  Serious Adverse Events must be reported to the 
Sponsor no later than three (3) calendar days from the day the site personnel became 
aware of the event or as per the investigative site’s local requirements, if the 
requirement is more stringent than those outlined above. All unresolved adverse events 
should be followed by the investigator until resolution.  
For subjects enrolled under version L or later of the protocol, the reporting of adverse 
events will commence at the time of the Portico implant attempt.  
 
9.4.2 Paravalvular Leak 
Paravalvular leak should be reported as an adverse event in the following cases: 
• When paravalvular leak remains moderate or severe after balloon dilatation, or 
• When valve-in-valve, surgical conversion or other intervention is required for any 
grade of paravalvular leak after implant. 
 
9.4.3 Reporting Unanticipated Adverse Device Effects  
An investigator shall submit to the Sponsor and the reviewing IRB a report of any 
unanticipated adverse device effect occurring during an investigation no later than three 
(3) calendar days from the day the site personnel first learns of the effect. 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 61 of 211  
9.5 
Classification of Causal Relationships 
For each adverse event, the causal relationship between the adverse event and the 
Portico Transcatheter Heart Valve and Delivery System, and the causal relationship 
between the event and the index procedure, will be assessed by the Investigator and 
reported as such on the Adverse Event case report form. Final causal relationships for 
events related to primary and secondary endpoint criteria according to the Valve 
Academic Research Consortium (VARC 2) definitions will be determined per CEC 
adjudication. 
 
9.6 
Subject Death 
Subject death is a potential outcome of a Serious Adverse Event that will be reported 
within three (3) calendar days from the time of the site personnel knowledge of the event, 
if the event occurs from the time of signed informed consent until the subject exits the 
study. 
Subject death will be subdivided specifically denoting cardiovascular and non-
cardiovascular mortality: 
1. Cardiovascular mortality includes any one of the following criteria: 
a. Any death due to proximate cardiac cause (such as MI, tamponade, worsening 
heart failure) 
b. Sudden or unwitnessed death  
c. Death of unknown cause 
d. All procedure-related deaths including those related to a complication of the 
procedure or treatment for a complication of the procedure 
e. Death caused by non-coronary vascular conditions such as cerebrovascular 
disease, pulmonary embolism, ruptured aortic aneurysm, dissecting 
aneurysm, or other vascular disease. 
2. Non-cardiovascular mortality includes any death in which the primary cause of death 
is clearly related to another condition (e.g. trauma, cancer, suicide) 
An Adverse Event CRF, Death CRF and relevant source documentation including the death 
certificate should be submitted to SJM. 
 
10 Independent Boards (Pivotal IDE and CAP) 
10.1 Clinical Events Committee 
An independent Clinical Events Committee (CEC), consisting of, at a minimum, an 
interventional cardiologist, cardiologist, cardiothoracic surgeon, and a neurologist will 
adjudicate events related to primary and secondary endpoint criteria according to the 
Valve Academic Research Consortium (VARC 2) definitions. The CEC will have final 
adjudication responsibilities for subject outcomes related to primary and secondary 
endpoint criteria. Members of the CEC cannot be investigators on the PORTICO Clinical 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 62 of 211  
Study. A charter that is agreed upon by both the Sponsor and the independent CEC 
governs the event adjudication process. 
 
10.2 Data Safety Monitoring Board (DSMB) (Pivotal IDE) 
An independent Data Safety Monitoring Board (DSMB) will be utilized to regularly 
review study progress with regard to safety of the pivotal IDE trial. Members of the 
DSMB cannot be investigators on the PORTICO Clinical Study. Board membership may 
consist of, but not limited to, a cardiologist, cardiac surgeon, neurologists, and a 
biostatistician. 
The primary responsibilities of the DSMB include: 
•  Review and validate the subject sample (i.e., review inclusion/exclusion deviations 
and other protocol deviations) 
•  Provide oversight for issues affecting general subject welfare 
•  Recommend premature study termination or modification of the trial for any 
perceived safety concerns 
At any time during the course of the study, the DSMB may offer opinions or make 
formal recommendations concerning aspects of the study that impact subject safety 
(e.g., safety-related protocol changes or input regarding adverse event rates associated 
with the investigational study). Additionally, the DSMB may act as an advisory panel for 
questions regarding informed consent, subject enrollment, protocol implementation, 
study endpoints, data discrepancies, and other issues that may present during the 
course of the study. A charter that is agreed upon by both the sponsor and the DSMB 
members governs the role and responsibility of this committee. 
The recommendations of the DSMB are not binding, and all final decisions related to 
modifications to the clinical investigational protocol rest with the Sponsor. 
 
11 Statistical Methods and Analysis (Pivotal IDE) 
This section describes the statistical methods and analysis of the pivotal IDE randomized 
cohort unless otherwise specified. The analysis will be performed on combined high-risk 
cohort and extreme-risk cohort.  
11.1 Analysis Populations 
The primary analysis will be based on the intention-to-treat (ITT) population. The ITT 
population is defined at the time that randomization treatment is assigned to the 
subject. For the primary analysis in this study, subjects will be analyzed according to 
their ITT arm, and the randomization day will be considered Day 0 when referring to a 
specific number of days. 
Additional populations will be used to confirm the results of the ITT population. 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 63 of 211  
• As Treated: defined as randomized subjects in whom treatment is initiated 
(defined as entering the procedure room). Subjects are analyzed according to the 
treatment initiated. Subjects who are randomized but do not have treatment 
initiated will be excluded from the As Treated analysis. The index procedure day 
will be considered Day 0 when referring to a specific number of days. 
• Per-protocol: defined as randomized subjects who have successful treatment 
with the assigned valve implanted and no deviation for inclusion/exclusion. The 
index procedure day will be considered Day 0 when referring to a specific 
number of days. 
11.2 Randomization and Stratification  
Subjects will be randomized per 1:1 ratio to test (Portico) vs. control (CAV) group 
according to a computer-generated randomization scheme.  Randomization will be 
stratified by each clinical site, then by risk cohort (high risk vs. extreme risk), and 
vascular access method (transfemoral vs. alternative access). The purpose of using the 
stratified randomization is to ensure balance of the treatment groups with respect to 
each clinical site and each of four strata (high risk TF, high risk AA, extreme risk TF, and 
extreme risk AA). Permuted blocks will be used within each stratum to achieve balance 
and block sizes will not be revealed to sites.  
 
11.3 Primary Endpoints 
11.3.1 Primary Effectiveness Endpoint  
The primary effectiveness endpoint is the composite endpoint of all-cause mortality or 
disabling stroke at one year. This endpoint will be evaluated by a non-inferiority test 
comparing the Portico test group to the control (CAV) group, and the primary analysis 
will be conducted on the ITT population. There were 8 subjects randomized but not 
treated in the trial when the trial was paused; these subjects will be excluded in the 
primary analysis and will be replaced with 8 additional randomized subjects.  The 
primary analysis will be performed based on combined high and extreme risk cohort 
with pooled access data.  
The primary analysis will be conducted on a dataset locked after all enrolled subjects 
have had their one-year study visit (except those withdrawn or lost-to-follow-up before 
one year). 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 64 of 211  
The study hypotheses are:  
Null hypothesis: The probability of a subject experiencing a primary effectiveness 
endpoint event at one year for the test group is inferior to the probability in the control 
group. 
Ho: ptest > pcontrol + Δp1  
 
 
Alternative hypothesis: The probability of a subject experiencing a primary effectiveness 
endpoint event at one year for the Portico test group is not inferior to the probability in 
the control group by more than Δp1.  
Ha: ptest <  pcontrol + Δp1  
where ptest is the probability of a subject experiencing a primary effectiveness endpoint 
event by one year in the Portico test group, pcontrol is the probability of a subject 
experiencing a primary effectiveness endpoint event by one year in the control group, 
and Δp1, the non-inferiority margin for the primary effectiveness endpoint, is set at 8%.  
ptest and pcontrol will be estimated as 1-year Kaplan-Meier event rates. The hypothesis will 
be tested at the one-sided 5% level of significance, i.e., the upper bound of the one-
sided 95% confidence interval for ptest - pcontrol must be entirely less than Δp1. 
 
Non-inferiority margin  
The selection of the non-inferiority margin is based upon clinically acceptable outcomes. 
It has been demonstrated that inoperable subjects with severe AS had a one-year 
mortality rate of 50%. Based on the data from the PARTNER trial for subjects who 
cannot undergo SAVR, the TAVR treated subjects had 31% mortality rate, therefore 
choosing a Delta (Δ) that is 30% of this rate will preserve more than half of 19% 
treatment effect. On the other hand, a non-inferiority margin of 7.5% was used for 
PARTNER A (high risk subjects), which is 31% of the one year mortality rate 24.2% for 
the High risk cohort for the TAVR group.  In a review of recent data on commercially 
available TAVR cases within the TVT registry48, the event rate for death or major stroke 
was reported to be 25%.  A non-inferiority margin of 8% represents 32% of the one year 
event rate.  
Hypothesis Test 
The hypothesis test will be performed by calculating the 95% one-sided upper 
confidence limit for the difference of (ptest - pcontrol), using Kaplan-Meier estimates for the 
event rates and standard errors.  This analysis is will be performed on all patients, 
combining data from the high risk cohort and extreme risk cohort.  If the upper 
confidence limit for the difference is less than 0.08, the Portico test group will be 
determined to be non-inferior to the control group. The standard error of the test 
statistic Ptest - Pcontrol is defined as SE = sqrt(SE(Ptest)2 + SE(Pcontrol)2), where SE(Ptest) and 
SE(Pcontrol) are Greenwood standard errors for the Kaplan-Meier estimates. 
If non inferiority is demonstrated, a reflex test for superiority will be performed to 
determine if the Portico test group is superior to the control group.  If the upper bound 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 65 of 211  
of the two-sided 95% CI for (ptest - pcontrol) is entirely < 0, superiority will be claimed. The 
hypotheses of superiority test are: 
Ho: ptest - pcontrol  ≥ 0 
Ha: ptest - pcontrol  <  0 
Subjects withdrawn or lost-to-follow-up without experiencing an endpoint event before 
one year will be considered censored at the time of withdrawal or loss to follow-up in the 
Kaplan-Meier analysis. 
 
11.3.2 Primary Safety Endpoint 
The primary safety endpoint is the non-hierarchical composite endpoint of all-cause 
mortality, disabling stroke, life-threatening bleeding requiring blood transfusion, acute 
kidney injury requiring dialysis, or major vascular complications at 30 days. This endpoint 
will be evaluated by a non-inferiority test comparing Portico test group to the control 
group, and the primary analysis will be conducted on the ITT population. There were 8 
subjects randomized in the trial when the trial was paused; these subjects will be excluded 
in the primary analysis and will be replaced with 8 additional randomized subjects. The 
primary analysis will be performed based on combined high and extreme risk cohort with 
pooled access data.  
The study hypotheses are:  
Null hypothesis: The probability of a subject experiencing a primary safety endpoint 
event at 30 days for the test group is inferior to the probability in the control group. 
Ho: test > control + Δp2  
 
 
Alternative hypothesis: The probability of a subject experiencing a primary safety 
endpoint event at 30 days for the test group is not inferior to the probability in the 
control group by more than Δp2.  
Ha: test < control + Δp2  
where test is the probability of a subject experiencing a primary safety endpoint event 
by 30 days in the Portico test group, control is the probability of a subject experiencing a 
primary safety endpoint event in the control group, and Δp2, the non-inferiority margin 
for the primary safety endpoint, is set at 8.5%.  The event rates, test and control, will be 
estimated as 30-day Kaplan-Meier event rates.  The hypothesis will be tested at the one-
sided 5% level of significance, i.e., the upper bound of the one-sided 95% confidence 
interval for test - control must be entirely less than Δp2. 
Non-inferiority margin  
The selection of the non-inferiority margin is based upon clinically acceptable outcomes. 
It has been demonstrated that inoperable subjects with severe aortic stenosis had a 1-
year mortality rate of 50%. Based on the data from the PARTNER trial for subjects who 
cannot undergo SAVR, the TAVR treated subjects have 31% mortality rate, therefore 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 66 of 211  
choosing a Delta (Δ) that is 30% of this rate will preserve more than half of 19% 
treatment effect. On the other hand, a non-inferiority margin of 7.5% was used for 
PARTNER A (high risk subjects), which is 31% of the one-year mortality rate 24.2% for 
the High risk cohort for TAVR group. A conservative value of 30% of the rate in the 
control group is chosen for the non-inferiority margin in each of the high risk and 
extreme risk groups:  
 
The expected control rate for the high-risk group is 27.59%, therefore Δp2 = 0.083 
(0.2759*0.30). 
The expected control rate for the extreme-risk group is 43.69%, therefore Δp2 = 0.131 
(0.4369*0.30). 
The expected control rate for combined high-risk and extreme-risk group by enrolling 
80% high risk subjects and 20% extreme risk subjects46 is 30.81%, therefore Δp2 = 0.092 
(0.3081*0.30). 
Therefore a conservative value of 8.5% is chosen as the non-inferiority margin for the 
primary safety endpoint for the combined high and extreme risk cohort. 
Hypothesis Test 
The hypothesis test will be performed by calculating a 95% one-sided upper confidence 
limit for the difference of (test - control), using the Kaplan-Meier estimates for the event 
rates and standard errors.  This analysis is performed on all patients, combing data from 
the high risk cohort and extreme risk cohort.  If the upper confidence limit for the 
difference is less than 0.085, the Portico test group will be determined to be non-
inferior to the control group.  The standard error of the test statistic Ltest - Lcontrol is 
defined as SE = sqrt(SE(Ltest)2 + SE(Lcontrol)2), where SE(Ltest) and SE(Lcontrol) are Greenwood 
standard errors for the Kaplan-Meier estimates. 
If non inferiority is demonstrated, a reflex test for superiority will be performed to 
determine if the Portico test group is superior to the control group.  If the upper bound 
of the two-sided 95% CI for (test - control) is entirely < 0, superiority will be claimed. The 
hypotheses of superiority test are: 
Ho: test  - control  ≥  0 
Ha: test - control <  0 
Subjects withdrawn or lost-to-follow-up without experiencing an endpoint event before 
30 days will be considered censored at the time of withdrawal or loss to follow-up in the 
Kaplan-Meier analysis. 
 
11.4 Sample Size Calculations 
Primary Endpoints Estimated event rates 
The primary endpoints event rates for the study have been selected following careful 
review of available literature on disease states and current therapies including TAVR and 
SAVR. 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 67 of 211  
Control group 
The control groups will be composed of subjects who receive an approved control 
transcatheter heart valve. The estimated primary endpoints event rates for the control 
group of each of the cohorts have been derived as follows:  
The efficacy assessment included composite event rate of all-cause mortality or 
disabling stroke for the valve procedure at 1-year for high risk and extreme risk patients. 
The mean cumulative rates derived from all included studies are presented in Table 2 in 
section 2.1.7.  
The safety data of TAVI/TAVR procedures are composite rate of all-cause mortality, 
disabling stroke, life threatening bleeding, acute kidney injury requiring dialysis or major 
vascular complications at 30 days. The mean cumulative rates from all included studies 
are presented in Table 3 in section 2.1.8. 
Test group 
The subject selection process and criteria will result in a population in the Portico Test 
groups comparable to those enrolled in the control groups. SJM believes that 
performing the TAVR procedure using the Portico device will result in event rates similar 
to the control groups. Therefore, for hypothesis and sample size assumptions, the 
primary endpoint event rates for the Portico Test group are assumed to be the same as 
the primary endpoints event rates for each cohort’s control group.  
Sample Size Calculation 
The sample sizes are estimated based on the primary effectiveness and safety endpoints 
and tests. The study is powered on combined high and extreme risk cohort. The sample 
size is calculated to achieve at least 80% power for both primary effectiveness and 
safety endpoints assuming 80% of subjects are high risk and 20% of subjects are 
extreme risk based on recent publication from the TVT registry46.   
 
11.4.1 Sample Size for the Primary Effectiveness Endpoint 
The operating characteristics of the statistical test for the primary effectiveness 
endpoint are calculated by simulating 10,000 trials for a given sample size using custom-
written software in the R software package. The expected proportion of subjects with a 
primary effectiveness endpoint event in the control and Portico test groups are 22.9% 
for high risk group and 29.6% for extreme risk group per Table 2. The expected 
proportion of subjects with primary effectiveness endpoint event in control and Portico 
test group for the combined cohort of 80% high risk subjects and 20% extreme risk 
subjects are each 24.24%. This event rate assumption is consistent with data reported 
on commercially available TAVR within the TVT registry48.  As TAVR is currently indicated 
in the United States for extreme risk or high risk, the TVT registry is representative of 
patients to be studied in the PORTICO pivotal IDE trial.  More than half of patients within 
the TVT registry have undergone transfemoral access and overall the rate of death or 
disabling stroke at 1 year is reported to be 26%, with transfemoral access providing 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 68 of 211  
safer outcomes.  Therefore, the event rate of the primary effectiveness endpoint at one 
year is assumed to be 25% for both control and Portico test groups. Using the above 
estimated event rates and an 8% non-inferiority margin, a sample size of 750 will 
provide 80% power at the 5% significance level to demonstrate non-inferiority of the 
Portico test group to the control group for the primary effectiveness endpoint. All power 
calculations assume 7.5% loss-to-follow-up per year. Subjects who are lost-to-follow-up 
without experiencing an endpoint event will be censored in the Kaplan-Meier analysis 
for the primary effectiveness endpoint. 
 
11.4.2 Sample Size for the Primary Safety Endpoint 
The operating characteristics of primary safety endpoint are calculated by simulating 
10,000 trials per scenario using custom-written software in the R software package.  All 
power calculations assume 5% loss-to-follow-up at 30 days. Subjects who are lost-to-
follow-up without experiencing an endpoint event will be censored in the Kaplan-Meier 
analysis for primary safety endpoint. 
The expected rates of subjects with primary safety endpoint event in control and Portico 
test group are both 27.59% for high-risk group and 43.69% for extreme-risk group. The 
expected rates of subjects with primary safety endpoint event in control and Portico test 
group for combined cohort by enrolling 80% high risk subjects and 20% extreme risk 
subjects are both 30.8%. Using the above estimated event rates and an 8.5% non-
inferiority margin a sample size of 750 will provide 80% power at the 5% significance 
level to demonstrate non-inferiority of the Portico test group to the control group for 
the primary safety endpoint. 
 
11.4.3 Total Sample Size 
The total sample size required for evaluating the primary effectiveness and safety 
endpoints is 750 and 750 subjects respectively. Thus the total sample size is 750 for the 
study.  
Using the above estimated event rates a sample size of 750 will achieve 80% power to 
demonstrate non-inferiority for both the primary effectiveness endpoint and primary 
safety endpoint.  To accommodate the replacement of the 8 subjects who were 
randomized but not treated when the trial was paused, the total number of randomized 
subjects required to evaluate the primary endpoints is 758. 
 
11.5 Secondary Endpoints 
All secondary endpoints are defined in section 1.3. Among these, 4 have hypotheses to 
be tested. The secondary study hypotheses are:  
• Severe aortic regurgitation (AR) at one year   
• Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year 
• Moderate or severe aortic regurgitation at one year 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 69 of 211  
• 6-minute walk at one year  
Non-inferiority tests will be performed for each endpoint.   The first and third endpoints 
will use tests of proportions, and the second and fourth endpoints will use a test of 
means.   
Specifically, null and alternative hypotheses for each endpoint are: 
• Severe aortic regurgitation at one year (higher proportion is worse) 
Ho:  θtest,1  ≥  θcontrol,1 + 0.04 
Ha:  θtest,1 < θcontrol,1 + 0.04 
Where θtest,1 and θcontrol,1 are the proportions of subjects with severe aortic 
regurgitation at 1 year in the Portico test and control groups, respectively. The test 
statistic is based on the Farrington-Manning method of testing non-inferiority of 
proportions. 
• KCCQ at one year (higher mean better) 
Ho: θtest,2  ≤  θcontrol,2 - 10 
Ha: θtest,2 > θcontrol,2 - 10 
Where θtest,2 and θcontrol,2 are the KCCQ scores at 1 year in the Portico test and 
control groups, respectively. The test statistic is based on a two-sample t-test.  
• Moderate or severe aortic regurgitation at one year (higher proportion is worse) 
Ho:  θtest,3  ≥  θcontrol3 +0.06 
Ha:  θtest,3 < θcontrol,3 + 0.06 
Where θtest,3 and θcontrol,3 are the proportions of patients with moderate or severe 
aortic regurgitation at 1 year in the Portico test and control groups, respectively. The 
test statistic is based on the Farrington-Manning method of testing non-inferiority of 
proportions. 
• 6-minute walk distance at one year (higher mean better) 
Ho: θtest,4  ≤  θcontrol,4 - 36 
Ha: θtest,4 > θcontrol,4 - 36 
Where θtest,4 and θcontrol,4 are the mean 6-minute walk distance at 1 year in the 
Portico test and control groups, respectively. The test statistic is based on a two-sample 
t-test. 
The non-inferiority margins for the 1-year severe aortic regurgitation endpoint is 4%, for 
the 1-year KCCQ score is 10 points, for the 1-year moderate or severe aortic 
regurgitation is 6%, and for the 1-year 6-minute walk is 36m.  
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 70 of 211  
11.6 Multiplicity Adjustment 
Multiplicity adjustment will apply to hypothesis testing for the superiority tests of 
primary endpoints and four non-inferiority tests of secondary endpoints (severe AR, 
KCCQ, moderate or severe AR, and 6-minute walk).  
If non-inferiority test of either primary endpoint fails to achieve statistical significance, 
superiority tests of primary endpoints and non-inferiority test of secondary endpoints 
will not be performed. If the primary endpoints of non-inferiority of effectiveness and 
safety are met, a sequential gate keeping strategy will be used in this study to ensure 
strong control of study-wise type I error for testing secondary endpoints and superiority 
of primary endpoint43, 44. 47. In the case that non-inferiority tests of both primary 
endpoints are demonstrated, the secondary endpoints of non-inferiority and primary 
endpoints of superiority tests will be performed subsequently according to the following 
pre-specified hierarchical order. The tests for the secondary endpoints will be conducted 
at one-sided tests at the 5% alpha level.  The superiority tests of the primary endpoints 
(tests 3 and 4 below) will be conducted as one-sided test at the 2.5% alpha level: 
1. Non-inferiority tests for severe AR at one year and KCCQ score at one year. 
Both tests have to be met at the 5% significance level in order to claim non-
inferiority of the Portico test group to the control group on each secondary 
of these endpoints. 
2. If the above two secondary endpoints are met, non-inferiority tests for 
moderate or severe AR and 6-minute walk at one year will be performed 
next. Both tests have to be met at the 5% significance level in order to claim 
non-inferiority of the Portico test group to the control group on each of these 
secondary endpoints. 
3. Finally, if the above endpoints met, superiority tests for the primary safety 
endpoint and effectiveness endpoint at one year will be performed. Both 
tests have to be met at the 2.5% significance level in order to claim 
superiority of each primary endpoint. 
Hypothesis testing will stop at the first failed test. 
 
11.7 Additional Analysis  
11.7.1 Subgroup Analysis: Sex/gender  
For the primary safety and effectiveness endpoints and secondary endpoints (aortic 
regurgitation, KCCQ score at one year, 6-minute walk at one year) tests will be 
performed to identify the interaction by treatment group and with gender. 
If the p-value statistic associated with the interaction is below 0.05, then interaction will 
be considered statistically significant and further analysis will be conducted on other key 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 71 of 211  
risk factors to identify baseline covariates that have differential treatment effect across 
randomization groups. 
 
11.7.2 Additional Analyses of Primary Effectiveness Endpoint  
11.7.2.1 Subgroup Analysis: Risk Status  
The primary effectiveness endpoint at one year will be summarized separately for the 
high-risk cohort and the extreme risk cohort. The one-sided 95% confidence interval for 
the difference in 1-year event rates will be calculated. 
11.7.2.2 Analysis Comparing Portico with each Control device 
Separate analyses will be performed to compare St Jude Medical’s Portico TAVR device to 
each company’s device in the control group that is used in the trial for primary 
effectiveness endpoint at one year. The one-sided 95% confidence interval for the 
difference in 1-year event rates will be calculated. 
In addition, hazard ratios as well as 12-month risk differences will be calculated with two-
sided 95% confidence intervals overall between devices and within each risk cohort. 
 
11.7.3 Additional Analyses of Primary Safety Endpoint 
11.7.3.1 Subgroup Analysis: Risk Status  
The primary endpoint and each individual component of the primary safety composite 
endpoint at 30 days will be summarized separately for the high-risk cohort and the 
extreme risk cohort. The one-sided 95% confidence interval for the difference in 30-day 
event rates will be calculated. 
 
11.7.3.2 Analysis Comparing Portico with each Control device 
Separate analyses will be performed to compare St Jude Medical’s Portico TAVR device to 
each company’s device in the control group that is used in the trial for primary safety 
endpoint at 30 days. The one-sided 95% confidence interval for the difference in 1-year 
event rates will be calculated. 
In addition, hazard ratios as well as 30-day risk differences will be calculated with two-
sided 95% confidence intervals overall between devices and within each risk cohort.  
 
11.7.3.3 Augmented Analysis of Primary Safety Endpoint including FlexNav Study 
Data 
Augmented analysis of the primary safety endpoint will be performed by combining the 
data for randomized Portico test group subjects with data from the FlexNav study, and 
data from up to 50 subjects enrolled in a prospective, multi-center single-arm FlexNav 
EU CE Mark study. The combined dataset of Portico subjects will be summarized for the 
primary safety endpoint and each individual component of the primary safety composite 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 72 of 211  
endpoint at 30 days. In addition, the combined dataset of Portico subjects will be tested 
for non-inferiority against the CAV control group using the same analysis methods as 
those employed in the primary analysis in Section 11.3.2. The Sponsor understands that 
FDA will treat these analyses as supportive analyses and that FDA will review the totality 
of the data in the PMA application.  
To assess poolability of the primary safety endpoint between the Portico subjects across 
studies, the log-rank test will be constructed by study. P-values of 0.15 or less will be 
considered as evidence of potential heterogeneity in the outcome. If there is no 
statistically significant difference between studies for the primary safety endpoint then 
the data will be considered poolable.  
 
11.7.4 Analysis of Descriptive Endpoints 
The descriptive endpoints listed in section 1.3 will be summarized using descriptive 
statistics including mean, standard deviation, median and range for continuous data and 
count and percentage for categorical data.  
 
11.8  Pooling Analysis 
To assess poolability of the primary effectiveness and safety endpoints across sites, Cox 
proportional hazard regression models will be constructed that model the hazard rate of 
a subject with a primary endpoint event as a function of treatment group, site, and the 
treatment group by site interaction. If the interaction term is significant at the 0.15 
significance level, the clinical relevance will be considered. In the pooling analysis, 
investigational sites that have less than ten (10) subjects enrolled will be grouped as one 
‘small’ center for the purpose of this analysis. If the number of subjects in this ‘small’ 
center exceeds the total number of subjects enrolled in the ‘biggest’ site, then multiple 
small sites will be created based on geographic region as appropriate. 
 
11.9  Additional Assessment 
An exploratory comparison of the rates of individual patient success attained by each 
group of subjects (ITT or as attempted) receiving either the test (Portico) or control 
devices will be performed. Individual patient success is defined as: 
1. Acute device success 
2. Discharged alive from the hospital without device-related major AEs (Includes AI 
≤ 1+)  
3. Survival to one year with:  
o No disabling stroke  
o No device-or procedure-related mortality  
o NYHA class ≤ 2, or improvement in by at least 1 level from baseline 
o No re-hospitalizations for valve related complications/dysfunction or 
congestive heart failure (CHF) due to aortic valve related causes 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 73 of 211  
4. No Permanent Pacemaker dependency at 1 year (excluding subjects with pre-
procedural conduction abnormalities).  
Pacemaker dependency defined by the presence of a high degree atrioventricular block 
(HDAVB; second [AV2] and third degree [AV3B]), or a slow (< 30 bpm) or absent 
ventricular escape rhythm during follow-up pacemaker interrogation.38 
 
11.10 Statistical Methods and Analysis (FlexNav Study, Registries and CAP) 
No formal hypotheses testing will be performed in the FlexNav study, Roll-in Registry, 
Valve-in-Valve Registry or the CAP.  Data collected in these cohorts will be summarized 
separately using descriptive statistics.  Please refer to Appendix V and Appendix W for 
further analysis plan details for the CAP and FlexNav study cohorts respectively. 
 
12 Study Termination/Withdrawal (Pivotal IDE and CAP) 
Active subject participation in the pivotal IDE is expected to last for five (5) years after 
index procedure unless the subject was randomized or assigned to a registry or FlexNav 
study but not implanted with a TAVR valve. Enrolled CAP subjects successfully implanted 
with a Portico valve will be followed for a minimum of one year and up to 5 years or 
upon study completion (whichever is reached first). 
If an enrolled subject was not implanted with a TAVR valve, the following will apply: 
• Randomized subjects will be followed per protocol through to the one-year visit, as 
part of the primary analysis intent to treat (ITT) population, and then terminated 
from the study. 
• Registry-assigned (Roll-in or VIV Registry), FlexNav study or CAP subjects will be 
assessed for any adverse events through 30 days post procedure, and then 
terminated from the study. 
The study will be closed at the investigational site following the distribution of the final 
clinical study report for all study locations. A copy of the final report will be provided to 
the IRB and Competent Authorities, if applicable, and acknowledgement requested.  
 Early termination of the study by either SJM or the Investigator, if applicable, will be 
communicated to the IRB. 
Upon completion of subject participation in this study, the subject will be followed-up in 
accordance with institutional standards.  
Possible reasons for early termination of the study and/or investigation site’s 
participation in the study may include, but are not limited to: 
• Request from the Clinical Investigation Site Principal Investigator 
• Delivery system or device fails to perform as intended 
• Occurrence of UADE which cannot be prevented in future cases 
• SJM management decision to discontinue the study 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 74 of 211  
• Request from Regulatory bodies 
• Site’s noncompliance with the requirements of the CIP and/or applicable 
laws and regulations  
• Falsification of data or any other breach of ethics or scientific principles 
Subjects must be informed about their right to withdraw from the study at any time and 
for any reason without sanction, penalty, or loss of benefits to which the subject is 
otherwise entitled and withdrawal from the study will not jeopardize their future 
medical care or their relationship with the Principal Investigator. Subjects will be asked 
what the reason for termination is but have the right not to answer. 
The Principal Investigator may withdraw a subject from the study at any time if s/he 
believes it is in the subject’s best interest.  
The subject’s future care will not be changed by a decision, voluntary or otherwise, to 
withdraw from the study. All reasonable efforts should be made to retain the subject in 
the clinical study until completion of the clinical study. 
Reasons for subject’s termination or withdrawal include, but are not limited to, the 
following: 
• Subject death (in case of subject death, cause must be documented)   
• Subject and/or family request, if applicable 
• Subject non-compliance 
• Subject lost to follow-up, defined as the following: a subject will be 
considered “lost to follow-up” after a minimum of 3 documented phone calls 
of a physician or designee at the study site to the subject or emergency 
contact and a letter sent to the last known address 
• Subject’s participation terminated by the Principal Investigator 
• Study discontinued due to management decision by sponsor or request from 
Regulatory bodies 
• Investigational site ends participation in the study 
The study will be terminated according to locally applicable regulations. If applicable, 
the study may be temporarily suspended or terminated, either at the local, national, or 
international level, at the request of the IRB and/or the FDA. Justification and request 
for resuming the clinical investigation after suspension will be communicated to the IRB 
and the FDA. 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 75 of 211  
13 Study Management (Pivotal IDE and CAP) 
SJM, as the study sponsor, is responsible for: 
• the design, overall conduct, analysis, and reporting of the results from this 
study as described in this CIP 
• conducting CIP and technical training of the Principal Investigator and Co-
Investigator(s) 
• conducting CIP training of clinical staff, including but not limited to, research 
coordinator(s), echocardiographers, procedural staff 
• monitoring the study  
• performing those actions necessary to protect the rights of subjects and the 
scientific credibility of this study is conducted 
• selecting qualified study Investigators, study monitors and research staff  
• safety reporting to Competent Authorities  
• providing support from a Field Clinical Specialist at each Portico valve implant 
• providing a proctor as support for each Portico valve implant until the 
proctor/SJM determines the site can function independently 
SJM reserves the right to obtain data clarification and/or additional medical 
documentation on subjects enrolled in this study until the study is terminated or closed 
by study final report. 
The Sponsor of this study and manufacturer of the investigational device is: 
 
St. Jude Medical (now Abbott) 
Attn: Global Clinical Affairs, PORTICO Clinical Study 
5050 Nathan Lane North 
Plymouth, MN 55442 USA 
Tel +651.756.5400 
 
SJM will retain, at a minimum, the following reports, records, publications: 
• Signed Clinical Investigation Plan and all amendments 
• Blank, revision controlled eCRFs  
• Informed Consent Form template, and all IRB-approved versions 
• Signed Study Agreements and all amendments completed  
• Investigator Financial Disclosure information and all updates thereto 
• IRB approval letters 
• Regulatory approval letters 
• All significant correspondence relating to the conduct of this study between 
SJM the study site, and IRB 
• Signed CVs and professional licenses (if applicable) for all study personnel 
• Training records relevant to conduct of the Clinical Investigation 
• CIP/device related training records for all applicable study personnel 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 76 of 211  
• Site personnel signatures and documentation of the Investigator’s delegation 
of study related responsibilities 
• Investigational device inventory information including the date, quantity, and 
unique identifier of all investigational devices shipped and received 
• Appropriate tracking of each investigational device to include implant, explant, 
return, and analysis 
• Publication Agreement 
• IRB Registration Number 
• List of IRB voting members (optional) 
• Insurance Certificate  
• Relevant Source Documentation (de-identified). 
 
13.1 Study Investigators 
Study Investigators are those who have been qualified and sufficiently trained by SJM on 
the study CIP requirements. Implanting Study Investigators have to complete required 
training as per the Training Plan prior to implanting the Portico Transcatheter Heart 
Valve. 
 
13.2 National Principal Investigators 
The following investigators have been appointed by the Sponsor as the study National 
Principal Co-Investigators: 
Dr. Greg Fontana, MD (Cardiac Surgeon) 
Los Robles Hospital and Medical Center 
215 West Janss Road 
Thousand Oaks, CA  91360 
(805) 497-2727 
Dr. Raj Makkar, MD (Interventional Cardiologist) 
Cedars-Sinai Medical Center 
8700 Beverly Blvd. 
Los Angeles, CA 90048 
(310) 423-3977 (Office) 
 
13.3 Investigator Responsibilities 
This investigation will be conducted in accordance with this clinical investigation plan, the 
signed Agreement, other agreements, amendments, applicable laws and regulations and 
any conditions of approval imposed by the IRB. To ensure compliance with guidelines, 
SJM, an independent body, or a regulatory agency may audit the investigation.  
An Investigator should have experience in and will be responsible for: 
• Providing signed Study Agreements and amendments 
• Complete device and clinical investigational plan training 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 77 of 211  
• Obtain and maintain IRB approval 
• Coordinating the execution of, and providing signed Financial Disclosure 
Questionnaires for Clinical Investigations to SJM and any subsequent updates; 
• Coordinating the execution of and providing signed required study documents to 
SJM 
• Providing appropriate Research IRB approved informed consent form 
• Conducting the clinical investigation in accordance with the signed agreement 
and any amendments with St Jude Medical, the investigation plan, all applicable 
laws and regulations, and any conditions of approval imposed by the appropriate 
IRB or applicable regulatory authorities where the investigation is performed 
• Collecting and archiving of data obtained after implant and at follow-up 
examinations and after the investigation has been completed 
• Strict adherence to the CIP testing requirements to provide for optimal safety 
and efficacious use of the device under clinical investigation 
• Screening and selecting appropriate subjects as described herein 
• Maintaining accurate investigational device accountability 
• Supporting the monitor and auditor, if applicable, in their activities to verify 
compliance with the CIP, to perform source data verification and to correct the 
electronic case report forms where inconsistencies or missing values are 
identified 
• Act as the main contact for all Co-investigators in case of medical questions 
related to the conduct of the investigation 
• Notifying the subject’s primary care physician of the subject’s participation in the 
study 
• Notifying SJM of any deviations to the CIP 
• Notifying SJM, the IRB and/or FDA of any SAEs, UADEs, or device deficiencies 
that could have led to an SAE.  
 
It is acceptable for the Principal Investigator to delegate one or more of the above 
functions to a trained associate or Co-Investigator, however, the Principal Investigator 
remains responsible for the proper conduct of the clinical study, complying with the CIP 
and collecting all required data. The study is not transferable to other implant centers 
attended by the Investigator unless prior written approval is obtained from SJM. New 
personnel may be added to the Investigation Team. These new team members may not 
perform any study-related duties without sufficient training specific to the clinical 
investigation requirements. 
 
13.4 Reports 
Table 12 includes details on required reporting obligations. 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 78 of 211  
Table 12. Reporting Obligations 
Report 
Submitted By 
Submit To 
Timeframe 
Unanticipated Adverse 
Device Effect (UADE), 
Serious Adverse Event 
(SAE). 
Principal Investigator, 
SJM 
SJM and IRB 
Within 3 calendar days 
from becoming aware of 
the event.  
Device deficiencies 
Principal Investigator, 
SJM 
SJM and IRB (If 
applicable)  
Within 3 calendar days 
from becoming aware of 
the event.  
Failure to obtain 
informed consent 
Principal Investigator, 
SJM 
SJM, IRB 
Within 5 working days  
Withdrawal of IRB 
Approval 
Principal Investigator 
SJM 
Within 5 working days  
Protocol deviation to 
protect the life or 
physical well-being of a 
subject in an 
emergency 
Principal Investigator 
IRB and Abbott 
Within 5 working days 
after the emergency 
occurred 
Annual Report 
Principal Investigator 
IRB and  Abbott 
Without unjustified 
delay, annually upon IRB 
approval date 
Annual Progress Report 
SJM 
Principal Investigator, 
IRB and FDA 
Annually, on approval 
date of IDE study 
Sub-study (Appendix S) 
Periodic Progress 
Reports 
SJM 
FDA 
After every fifty (50) 
randomized subjects 
complete 30-Day imaging 
(MSCT or TEE), analyzed 
by the Core Lab 
Sub-study (Appendix S) 
Final Report 
SJM 
Principal Investigator, 
IRB and FDA 
After a minimum of 200 
randomized subjects 
complete both 30-Day 
and 6-Month imaging 
(MSCT or TEE), analyzed 
by the Core Lab.  
Final 
SJM 
Principal Investigator,  
IRB, and FDA  
Within 6 calendar 
months following the 
completion or 
termination of the study  
Final 
Principal Investigator 
IRB and Abbott 
Within 3 calendar 
months following the 
completion or 
termination of the study 
at the study site 
 
 
 
 
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 79 of 211  
13.5 Records 
Records to be maintained by the Principal Investigator in a designated study file include, 
but are not limited to: 
• Investigation plan and all amendments 
• Signed Study Agreement and all amendments 
• Report of Prior Investigations (ROPI) 
• IRB approval letters, including a copy of all versions of the approved informed 
consent form, progress reports, AE reports 
• IRB Registration Number 
• List of IRB voting members (optional) 
• Insurance certificate 
• All correspondence relating to the conduct of this study between the site, sponsor 
and IRB 
• Signed CVs and professional licenses (if applicable) for all study personnel 
• Training records relevant to conduct of the Clinical Investigation 
• Site personnel signatures and documentation regarding the Principal 
Investigator’s delegation of responsibilities 
• Site Visit Log 
• Blank copies of each version of eCRFs 
• Documentation of all approved changes made to informed consent form 
• Documentation of FDA approval and communication 
• CIP/device related training records for all applicable study personnel  
• Investigational device inventory information including the date, quantity, and 
unique identifiers for all devices shipped and received, identification of all subjects 
in whom the device was used, and final disposition of all devices received 
• Enrollment Log including all procedurally excluded subjects  
• Financial Disclosure documentation for the Principal Investigator and all Co-
Investigators. 
The following records must be maintained by the Principal Investigator for each subject 
enrolled: 
• Completed eCRFs 
• Subject Identification Log 
• Source documentation for SAEs and AEs  
• Signed and dated informed consent forms 
• Complete medical records including procedure reports, lab reports, source 
documents  
• Records pertaining to a subject’s death during the study (if applicable) 
 
13.6 Record Retention 
Subject study records, correspondence files, all supporting study documentation, and 
reports must remain on file at the study site for a minimum of two (2) years, or longer 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 80 of 211  
per local laws, after the termination of this study or when it is no longer needed to 
support a marketing application within or outside of the U.S., whichever is the latter. 
The Principal Investigator must contact SJM prior to destroying or archiving off-site any 
records and reports pertaining to this study to ensure that they no longer need to be 
retained on-site. 
The Investigator Study Binder must be safely archived after termination of the 
investigation. It is the responsibility of the investigator to ensure that the subject 
identification logs are stored for a minimum period of two (2) years after the latter of 
following 2 dates: the date on which the study is terminated or completed, or the date 
that the records are no longer required to support a PMA. All original subject files must 
be stored for the longest possible time permitted by the regulations at the hospital, 
research institute, or practice in question. If archiving can no longer be maintained at 
the site, the investigator will notify SJM.  
Additionally, SJM must be contacted if the Principal Investigator plans to leave the 
study site to ensure that arrangements for a new Investigator or records transfer are 
made prior to the Investigator’s departure. If the Principal Investigator wishes to 
withdraw from the responsibility of maintaining custody of the study records, FDA must 
also be notified by the Principal Investigator not later than 10 working days after the 
transfer of records to another party who will accept responsibility for the records, 
including the responsibilities during an FDA/IRB/SJM inspection. 
 
13.7 Confidentiality 
All subject information collected during the course of this study will be kept strictly 
confidential according to applicable country-specific laws and regulations. All data and 
information concerning subjects and their participation in this study are considered 
confidential by Sponsor, and its affiliates (located in the U.S.A. and European Economic 
Area (EEA), and other countries), and other people who work for Sponsor to provide 
services related to the device and this study (collectively referred to as “SJM”). All public 
reporting of the results of the study will eliminate identifiable references to the 
subjects.  Information on paper will be kept in secured locations. Electronic information 
will be kept on password-protected computers. 
Personal data, including medical and health information, will be processed both by 
computer and manually, during and after the study by Sponsor, and its affiliates, its 
designated third party data processors, the IRB, the institution conducting the study, the 
study doctors and other healthcare personnel involved in the study for the purposes of 
this study. The electronic data stored for this study will be kept in the Sponsor database, 
in compliance with part 11 of the US Code of Federal Regulations.  Subject data will not 
contain details of study subject identity.  The data will be stored on a secure server and 
backed up routinely.  All records and reports required by or prepared in connection with 
this study shall be maintained by the institution and the site’s Principal Investigator in a 
secure location for a minimum period of 2 years after the latter of the following 2 dates: 
the date on which the study is terminated or completed, or the date that the records 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 81 of 211  
are no longer required to support a PMA. Personal data will be key-coded to prevent 
subject identification, except by the institution, study doctors and other healthcare 
personnel involved in the study, if necessary for the purpose of the study, for regulatory 
inspections, and to comply with sponsor reporting obligations. 
Study subjects have a right to gain access and to correct inaccuracies in information 
about them as permitted by applicable law.  In order to help keep subject medical 
records and personal information confidential only certain authorized investigators and 
sponsor personnel, or approved contracted agents of the sponsor, will have access to 
confidential records. These include researchers in the hospital who are part of this 
study, the sponsor and its affiliates and representatives that perform study-related 
services who may be located in the USA, European Economic Area (EEA) and other 
countries. The IRB and other regulatory authorities also have the right to inspect and 
copy records pertinent to this study. It is necessary for them to review study data, 
portions of study subject records and information so that they can follow the study 
progress, which may include without limitation: 
1. monitor the accuracy and completeness of the study 
2. perform scientific analysis and develop the medical product  
3. and/or obtain approval to market the medical products in the USA, Canada, EEA, 
and other countries. 
Any information about subjects that leaves the institution conducting the study will be 
modified to remove certain information that could identify the subject (e.g., subject’s 
name, address, and hospital number) and only be identifiable by a study ID code. Study 
data provided to sponsor that is published in medical journals and/or presented at 
scientific conferences will not allow the identification of study subjects.  
The results of the study will be made available to the sponsor and its affiliates (located 
in the U.S.A., EEA, and other countries) along with other people who work for the 
sponsor to provide services related to the device and this study and study center. 
A summary of the information on all subjects may be provided to governmental 
agencies (including regulatory agencies), regulatory authorities in the U.S.A., Canada, 
EEA and other countries who may also need to review study data and portions of 
medical records.  Results from this study may also be published in scientific journals or 
presented at conferences as an oral or poster presentation; however, the identity of a 
study subject will not be disclosed. 
 
13.8 Amendment Procedure  
If an amendment becomes necessary during the study, the site along with SJM will 
submit the CIP amendment to the IRB. SJM will submit the amendment to the FDA, as 
required. Prior approval from the FDA and IRB will need to be obtained, when 
applicable, prior to the implementation of the change except in an emergency situation 
to protect the health and welfare of the subject(s) as deemed necessary by the Principal 
Investigator.  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 82 of 211  
A justification statement shall be included with each amended section of the CIP 
documentation, and the version number and dates of amendments will be documented.  
 
13.9 Ethical Basis 
The PORTICO clinical study will be performed in compliance with all applicable Federal 
regulations concerning the protection of human subjects found in the Code of Federal 
Regulations (CFR) and 21 CFR Parts 50 and 56. 
This clinical investigation will be performed in accordance with the World Medical 
Association Declaration of Helsinki and 21 CFR parts 54 and 812. 
IRB approval letter should clearly identify: 
• the date of the meeting 
• duration of approval or expiration date of approval  
• the approved version of the Clinical Investigation Plan 
• the approved version of the informed consent form and any other advertising or 
subject recruitment materials 
• the approved version of the Instructions for Use (IFU) 
Approval from the IRB is necessary prior to the start of the investigation. The original 
approval is to be filed in the Investigator Study Binder and a copy of the approval is 
provided to SJM prior to the first investigational assessment. 
Any amendments to the CIP should be submitted to the FDA.  Approval of amendments 
shall be obtained in written form from the FDA and IRB prior to implementation. 
The IRB will be informed about SAEs, UADEs, and protocol deviations in accordance with 
local and national requirements. 
 
13.10  Insurance 
Subjects will be allowed to participate in the study regardless of their personal health 
insurance status.  
 
13.11 Subpopulations 
The PORTICO clinical study will include study patients with severe, symptomatic aortic 
stenosis that can be considered as one of three subpopulations: 
• High operative risk for surgical aortic valve replacement 
• Extreme operative risk for surgical aortic valve replacement 
• Patients at either high or extreme operative risk who will have a TAVR valve 
implanted in an existing failed bioprosthetic surgical aortic valve.  
 
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 83 of 211  
13.12 Underrepresented Group Considerations 
Since findings based on data collected from trials are commonly used to support the 
application of therapies across the general population, it is important that the enrolled 
patient population be as representative as possible of the eligible population in terms of 
the racial, ethnic and gender mix.  
The PORTICO clinical study inclusion and exclusion criteria do not unduly exclude any 
particular underrepresented group. In order to facilitate access to the study by 
underrepresented groups, the PORTICO clinical study will be conducted at sites 
throughout the United States and Australia and will consist of urban as well as rural 
facilities. Steps (e.g., translation of ICF to native language, financial hardship program, 
etc.) will be taken to ensure inclusion of underrepresented groups. 
 
13.13  Study Monitoring 
Investigational sites will be monitored to ensure the study is being conducted in 
accordance with this Clinical Investigation Plan, Investigator Agreement, applicable laws 
and regulations and SJM policies and procedures. Qualified clinical representatives will 
be selected to monitor this study.  If required, a study-specific Monitoring Plan will be 
created. The Monitoring Plan will be in accordance with SJM procedures and will be 
updated as appropriate.  
St. Jude Medical (or their designee) will conduct periodic visits to monitor the study 
progress. The Investigator will make subject and study records available to the clinical 
monitor for periodic inspection. The clinical monitor will review subject records to verify 
that they are accurate and up to date and to ensure compliance with all requirements of 
the CIP and applicable national and local regulations and competent authorities. Clinical 
monitoring will be conducted according to SJM procedures. 
 
13.14  Regulatory Inspections 
The Investigator and/or designee should contact SJM immediately upon notification of 
an impending FDA inspection. 
An Investigator who has authority to grant access shall permit authorized FDA 
employees, at reasonable times and in reasonable manner, to enter and inspect any 
establishment where devices are held (including any establishment where devices are 
used or where records or results are kept). 
An Investigator, or designee, shall permit authorized FDA employees, at reasonable 
times and in a reasonable manner, to inspect and copy all records relating to an 
investigation. 
An Investigator shall permit authorized FDA employees to inspect and copy records that 
identify subjects, upon notice that FDA has reason to suspect that adequate informed 
consent was not obtained, or that reports required to be submitted by the investigator, 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 84 of 211  
to the sponsor or IRB have not been submitted or are incomplete, inaccurate, false, or 
misleading. 
 
13.15  Compliance 
It is the responsibility of SJM to promptly secure compliance from any study site that is 
not complying with the requirements of this study. If a monitor is unable to secure 
compliance, the SJM Project Manager must be notified immediately. The Project 
Manager will work directly with the monitor and site to implement a compliance action 
plan. If the site does not complete the activities outlined in the compliance action plan, 
or if the noncompliance is considered significant and may affect the scientific soundness 
of the study or safety of the subjects, SJM may terminate the Investigator’s participation 
in the study. 
 
13.16  Protocol Deviation 
The Principal Investigator and delegates are required to adhere to the Clinical 
Investigation Plan, signed Study Agreement, applicable national or local laws and 
regulations, and any conditions required by the reviewing IRB or applicable regulatory 
authorities. 
A protocol deviation is used to describe situations in which the CIP was not followed. All 
deviations must be reported to SJM on the Protocol Deviation Case Report Form. 
Deviations must be reported to the IRB per their requirements. Any corrective and 
preventive actions required by the IRB must be completed by the site. 
The Investigator must notify SJM and the IRB (as required by the IRB’s requirements) of 
any deviation from the Investigation Plan to protect the life or physical well-being of a 
subject in an emergency as soon as possible, but no later than 5 working days after the 
deviation has occurred.  
SJM retains the right to terminate the participation of a study Investigator for any of, 
but not limited to, the following reasons: 
• Concern for subject safety and welfare 
• Failure to secure informed consent prior to any study activity 
• Failure to report unanticipated adverse device effects without unjustified delay  
• Repeated non-compliance with this Investigation Plan or the Study Agreement 
• Inability to successfully implement this Investigation Plan 
• Violation of the Declaration of Helsinki 
• Violation of applicable national or local laws and regulations 
• Falsification of data, or any other breach of ethics or scientific principles 
• Loss of or unaccounted use of investigational device inventory 
• Management decision by SJM 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 85 of 211  
13.17  Device Accountability 
The study site must maintain device accountability records documenting the receipt, 
expiration date, and final disposition (e.g., subject ID if implanted, attempted, or 
returned to SJM) of all investigational devices. The unique device identifiers and date 
received must be documented on the log for all valves and delivery systems upon 
receipt and include the initials of the person completing the log. All devices that are 
opened must be accounted for on the device accountability log, even if they are not 
used. 
SJM must also maintain device accountability documenting all shipments and returns of 
investigational devices by unique device identifier, date, and person completing the log. 
Storage locations for the investigational devices will be locked with access restricted 
only to investigators or designee. 
 
13.18 Economic and Quality of Life Analysis 
In conjunction with the clinical study, the costs and benefits of treatment will be 
evaluated through an economic and quality of life analysis. Medical resource use, cost 
and health-related quality of life within the trial period will be compared between 
treatment groups. If the Portico device is found to be safe and effective, its long-term 
cost-effectiveness will be assessed. The economic and quality of life analysis will be fully 
integrated into the clinical trial, with a common informed consent form and collection of 
subject reported resource use in the case report form.  
 
13.19 Publications  
Upon receiving Investigational Device Exemption from FDA, the PORTICO clinical study 
will be registered on www.clinicaltrials.gov. The trial will adhere to the publication 
principles of the International Committee of Medical Journal Editors (ICMJE).  
Once a PMA or final report is accepted and reviewed by FDA, the results of the PORTICO 
clinical study will be published within 24 months of the end of data collection. A full 
report of the primary outcomes from the PORTICO clinical study will be made public no 
later than three (3) years after the end of data collection.  
No study results obtained under this protocol, nor any information provided to the 
investigator for the purposes of performing the study, will be published or passed on to 
any third party without the consent of SJM. Investigators are obligated to follow the SJM 
publication policy. 
 
13.20  Investigational Site Start-up 
13.20.1 
Study Initiation Visit 
Prior to beginning the study, SJM personnel will contact the Investigator to discuss the 
CIP and review the data requirements in detail. 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 86 of 211  
 
13.20.2 
 Site Activation 
Before a site is activated and allowed to enroll subjects, the following documents, at a 
minimum, must be received by SJM: 
• 
copy of FDA letter of approval 
• 
copy of IRB letter of approval, along with a copy of the approved informed consent form 
• 
fully Executed Study Agreement 
• 
current Curriculum Vitae (signed and dated) of the Principal Investigator  
 
14 Sponsor Contact Information  
To contact the Sponsor regarding the PORTICO Clinical Study: 
 
St. Jude Medical (now Abbott) 
Attn:  Global Clinical Affairs, PORTICO Clinical Study 
5050 Nathan Lane North 
Plymouth, MN 55442 USA 
Tel 651.756.5400 
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 87 of 211  
15 Bibliography 
1. Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, 
Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective 
survey of patients with valvular heart disease in Europe: The Euro Heart Survey on 
Valvular Heart Disease. Eur Heart J 2003; 24:1231—43. 
2. Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a 
population-based study. Lancet 2006;368:1005-11. 
3. R.V. Freeman, C.M. Otto. Spectrum of calcific aortic valve disease pathogenesis, 
disease progression, and treatment strategies. Circulation, 111 (2005), pp. 3316–
3326. 
4. C.M. Otto, I.G. Burwash, M.E. Legget et al. A prospective study of asymptomatic 
valvular aortic stenosis clinical, echocardiographic, and exercise predictors of 
outcome Circulation, 95 (1997), pp. 2262–2270. 
5. R. Rosenhek, U. Klaar, M. Schemper et al. Mild and moderate aortic stenosis. 
Natural history and risk stratification by echocardiography. Eur Heart J, 25 (2004), 
pp. 199–205. 
6. P.A. Pellikka, M.E. Sarano, R.A. Nishimura et al. Outcome of 622 adults with 
asymptomatic, hemodynamically significant aortic stenosis during prolonged 
follow-up. Circulation, 111 (2005), pp. 3290–3295. 
7. Ross J Jr, Braunwald E. Aortic stenosis. Circulation. 1968; 38 (Suppl I): I-61–I-67. 
8. Bonow RO, Carabello BA, Kanu C, de Leon Jr AC, Faxon DP, Freed MD, Gaasch WH, 
Lytle BW, Nishimura RA, O’Gara PT, O’Rourke RA, Otto CM, Shah PM, Shanewise JS, 
Smith Jr SC, Jacobs AK, Adams CD, Anderson JL, Antman EM, Faxon DP, Fuster V, 
Halperin JL, Hiratzka LF, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B. 
ACC/AHA 2006 guidelines for the management of patients with valvular heart 
disease: a report of the American College of Cardiology/American Heart Association 
Task Force on Practice Guidelines (writing committee to revise the 1998 Guidelines 
for the Management of Patients With Valvular Heart Disease): developed in 
collaboration with the Society of Cardiovascular Anesthesiologists: endorsed by the 
Society for Cardiovascular Angiography and Interventions and the Society of 
Thoracic Surgeons. Circulation 2006; 114: e84—231. 
9. Bach DS, Siao D, Girard SE, Duvernoy C, McCallister Jr BD, Gualano SK. Evaluation of 
patients with severe symptomatic aortic stenosis who do not undergo aortic valve 
replacement: the potential role of subjectively overestimated operative risk. 
Circulation 2009;2:533—9.  
10. Schwartz B, Facklam RR, Breiman RF. Changing epidemiology of group A 
streptococcal infection in the USA Lancet 1990;336:1167-1171. 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 88 of 211  
11. O’Keefe Jr JH, Shub C, Rettke SR. Risk of noncardiac surgical procedures in patients 
with aortic stenosis Mayo Clin Proc 1989;64:400-405 
12. Leon, M. B., Smith, C. R., Mack, M., Miller, D. C., Moses, J. W., Svensson, L. G., et al. 
Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot 
Undergo Surgery. New England Journal of Medicine, 363(17), 1597-1607. 
13. Murakami, T., Kikugawa, D., Endou, K., Fukuhiro, Y., Ishida, A., Morita, I., Masaki, H., 
Inada, H. and Fujiwara, T. (2000), Changes in Patterns of Left Ventricular 
Hypertrophy After Aortic Valve Replacement for Aortic Stenosis and Regurgitation 
with St. Jude Medical Cardiac Valves. Artificial Organs, 24: 953–958. 
doi: 10.1046/j.1525-1594.2000.06641. 
14. Safian RD, Berman AD, Diver DJ, McKay LL, Come P, Riley M, Warren S, Cunningham 
MJ, Wyman MR, Weinstein JS, Grossman W, McKay RG. Balloon aortic valvuloplasty 
in 170 consecutive patients. New England Journal of Medicine 1988; 319: 125-130.  
15. Culliford AT, Galloway AC, Colvin SB, et al. Aortic valve replacement for aortic 
stenosis in persons aged 80 years and over. Am J Cardiol 1991;67:1256-60. 
16. Kvidal P, Bergstrom R, Horte LG, et al. Observed and relative survival after aortic 
valve replacement. J Am Coll Cardiol 2000;35:747-56. 
17. Astor BC, Kaczmarek RG, Hefflin B, et al. Mortality after aortic valve replacement: 
results from a nationally representative database. Ann Thorac Surg 2000;70:1939-
45. 
18. Burr LH, Jamieson WR, Munro AI, et al. Porcine bioprostheses in the elderly: clinical 
performance by age groups and valve positions. Ann Thorac Surg 1995;60:S264-9. 
19. Birkmeyer JD, Siewers AE, Finlayson EV, et al. Hospital volume and surgical 
mortality in the United States.NEngl J Med 2002;346:1128-37. 
20. Bonow RO, Carabello BA, Chatterjee K, et al. ACC/AHA 2006 guidelines for the 
management of patients with valvular heart disease: a report of the American 
College of Cardiology/American Heart Association Task Force on Practice Guidelines 
(writing Committee to Revise the 1998 guidelines for the management of patients 
with valvular heart disease) developed in collaboration with the Society of 
Cardiovascular Anesthesiologists endorsed by the Society for Cardiovascular 
Angiography and Interventions and the Society. 
21. Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Sebagh L, Bash A, Nusimovici 
D, Litzler PY, Bessou JP, Leon MR. Early experience with percutaneous transcatheter 
implantation of heart valve prosthesis for the treatment of end-stage inoperable 
patients with calcific aortic stenosis. J Am Coll Cardiol. 2004;43:698 –703. 
22. Grube E, Laborde JC, Gerckens U, et al. Percutaneous implantation of the CoreValve 
self-expanding valve prosthesis in high-risk patients with aortic valve disease: the 
Siegburg first-in-man study. Circulation 2006;114:1616-24. 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 89 of 211  
23. Grube E, Laborde JC, Zickmann B, et al. First report on a human percutaneous 
transluminal implantation of a self-expanding valve prosthesis for interventional 
treatment of aortic valve stenosis. Catheter Cardiovasc Interv 2005;66:465-9. 
24. Hanzel GS, Harrity PJ, Schreiber TL, et al. Retrograde percutaneous aortic valve 
implantation for critical aortic stenosis. Catheter Cardiovasc Interv 2005;64:322-6. 
25. Webb JG, Chandavimol M, Thompson CR, et al. Percutaneous aortic valve 
implantation retrograde from the femoral artery. Circulation 2006;113:842-50. 
26. Grube E, Schuler G, Buellesfeld L, et al. Percutaneous aortic valve replacement for 
severe aortic stenosis in high-risk patients using the second- and current third 
generation self-expanding CoreValve prosthesis: device success and 30-day clinical 
outcome. J Am Coll Cardiol 2007;50:69-76. 
27. Webb JG, Pasupati S, Humphries K, et al. Percutaneous transarterial aortic valve 
replacement in selected high-risk patients with aortic stenosis. Circulation 
2007;116:755-63. 
28. Cribier A, Eltchaninoff H, Tron C, et al. Treatment of calcific aortic stenosis with the 
percutaneous heart valve: mid-term follow-up from the initial feasibility studies: 
the French experience. J Am Coll Cardiol 2006;47:1214-23. 
29. Andersen HR, Knudsen LL, Hasenkam JM. Transluminal implantation of artificial 
heart valves: description of a new expandable aortic valve and initial results with 
implantation by catheter technique in closed chest pigs. Eur Heart J. 1992;13:704 –
708. 
30. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of 
an aortic valve prosthesis for calcific aortic stenosis: first human case description. 
Circulation 2002; 106: 3006-8. 
31. http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-
memo.aspx?NCAId=257”.  Last accessed 01 Nov 2012 
32. Willson AB, et al. Transcatheter aortic valve replacement with the St. Jude Medical 
Portico valve: first-in-human experience. J Am Coll Cardiol. 2012 Aug 14;60(7):581-
6. 
33. Manoharan G 2012 (Oct) Prospective, Multicenter Evaluation of the Portico 
Transcatheter Aortic Valve: Acute Results and 1-year Outcomes,  TCT , Miami FL 
34. Smith CR, Leon MB, Mack MJ et al., Transcatheter versus surgical aortic-valve 
replacement in high-risk patients. N Engl J Med 2011;364:2187-98. PARTNER cohort 
A. 
35. http://riskcalc.sts.org/STSWebRiskCalc273/ 
36. Piazza N, Bleiziffer S, Brockmann G, et al. Transcatheter Aortic Valve Implantation 
for Failing Surgical Aortic Bioprosthetic Valve: From Concept to Clinical Application 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 90 of 211  
and Evaluation (Part 1). J Am Coll Cardiol Intv. 2011;4(7):721-732.  
doi:10.1016/j.jcin.2011.03.016. 
37. Kappetein, A. P., Head, S. J., Généreux, P., Piazza, N., van Mieghem, N. M., 
Blackstone, E. H., et al. Updated standardized endpoint definitions for transcatheter 
aortic valve implantation: the Valve Academic Research Consortium-2 consensus 
document. European Heart Journal, 33(19), 2403-2418.  
38. Robert M.A. van der Boon, Nicolas M. Van Mieghem, Dominic A. Theuns, Rutger-Jan 
Nuis, Sjoerd T. Nauta, Patrick W. Serruys, Luc Jordaens, Ron T. van Domburg, Peter 
P.T. de Jaegere, Pacemaker dependency after transcatheter aortic valve 
implantation with the self-expanding Medtronic CoreValve System, International 
Journal of Cardiology, Available online 5 January 2013, ISSN 0167-5273, 
10.1016/j.ijcard.2012.11.115. 
39. Eggebrecht H, Schmermund A, Voigtlander T, Kahlert P, Erbel R, Mehta RH. Risk of 
stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 
10,037 published patients. EuroIntervention 2012;8:129–138. 
40. Linke A. The ADVANCE TAVR registry. TCT 2012; October 22, 2012; Miami, FL. 
41. Buchanan GL, Chieffo A, Montorfano M, et al. The role of sex on VARC outcomes 
following transcatheter aortic valve implantation with both Edwards SAPIEN™ and 
Medtronic CoreValve ReValving System® devices: the Milan registry. 
EuroIntervention 2011;7:556-63. 
42. Humphries K, Toggweiler S, Rodés-Cabau J, et al. Sex differences in mortality after 
transcatheter aortic valve replacement for severe aortic stenosis. J Am Coll Cardiol 
2012; DOI: 0.1016/j.jacc.2012.05.009. 
43. Marcus, R., Peritz, E., Gabriel, K. R. (1976). On closed testing procedures with 
special reference to ordered analysis of variance. Biometrika 63:655–660. 
44. Hung, H.M.J. and Wang, S.-J. (2009). Some controversial multiple testing problems 
in regulatory applications. Journal of Biopharmaceutical Statistics, 19: 1-11. 
45. http://www.cardiosource.org/~/media/Files/Science%20and%20Quality/Clinical%2
0Trials/ACC%2013%20Slides/PARTNER%20II%20Presentation%20Slides.ashx 
46. Mack MJ, Brennan JM, Brindis R, Carroll J, Edwards F, Grover F, Shahian D, Tuzcu 
EM, Peterson ED, Rumsfeld JS, Hewitt K, Shewan C, Michaels J, Christensen B, 
Christian A, O'Brien S, Holmes D; STS/ACC TVT Registry. Outcomes following 
transcatheter aortic valve replacement in the United States. JAMA. 2013 Nov 
20;310(19):2069-77. doi: 10.1001/jama.2013.282043. 
47. Hochberg, Y. (1988) A sharper Bonferroni procedure for multiple tests of 
significance. Biometrika, 75, 800-803. 
48. Holmes Jr. DR, et al.  Clinical Outcomes at 1 Year Following Transcatheter Aortic 
Valve Replacement. JAMA 2015; 313(10):1019-28. 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 91 of 211  
16 APPENDICES 
Appendix A: Abbreviations 
 
Abbreviation 
Term 
6MWT 
Six Minute Walk Test 
AA 
Alternative Access 
ACC 
American College of Cardiology 
ACT 
Activated Clotting Time 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AF 
Atrial Fibrillation 
AHA 
American Heart Association 
ARB 
Angiotensin Receptor Blocker 
AS 
Aortic Stenosis 
AV 
Aortic Valve 
AVA 
Aortic Valve Area 
AVR 
Aortic Valve Replacement 
BARC 
Bleeding Academic Research Consortium 
BNP 
B-type Natriuretic Peptide 
CAD 
Coronary Artery Disease 
CAP 
Continued Access Protocol 
CAV 
FDA Approved and Commercially Available Transcatheter Valve 
CBC 
Complete Blood Count 
CCS 
Canadian Cardiovascular Society 
CE 
Conformité Européene (European Conformity) 
CEC 
Clinical Events Committee 
CIP 
Clinical Investigation Plan 
CMS 
Centers for Medicare & Medicaid Services 
CPB 
Cardiopulmonary Bypass 
eCRF 
Electronic Case Report Form 
CT 
Computed Tomography 
CV 
Curriculum Vitae 
CVA 
Cerebral Vascular Accident 
DSMB 
Data Safety Monitoring Board 
ECG 
Electrocardiogram 
Echo 
Echocardiography 
eDC 
Electronic Data Capture 
EEA 
European Economic Area 
EF 
Ejection Fraction 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 92 of 211  
Abbreviation 
Term 
EOA 
Effective Orifice Area 
EU 
European Union 
FDA 
Food and Drug Administration 
GI 
Gastro Intestinal 
HOCM 
Hypertrophic cardiomyopathy with or without obstruction 
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption 
IFU 
Instructions For Use 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
ITT 
Intent To Treat 
KCCQ 
Kansas City Cardiomyopathy Questionnaire 
Kg 
Kilogram 
LBBB 
Left Bundle Branch Block 
LV 
Left Ventricular 
LVEF 
Left Ventricular Ejection Fraction 
MAC 
Mitral Annular Calcification 
MI 
Myocardial Infarction 
MMSE 
Mini-mental state examination 
MR 
Mitral Regurgitation 
MRI 
Magnetic Resonance Imaging 
mRS 
Modified Rankin Scale 
MSCT 
Multi-Slice Computed Tomography 
NCD 
National Coverage Determination 
NIHSS 
NIH Stroke Scale 
NYHA 
New York Heart Association 
PA 
Pulmonary Artery 
PCI 
Percutaneous Coronary Intervention 
PCWP 
Pulmonary Capillary Wedge Pressure 
PI 
Principal Investigator 
QoL 
Quality of Life 
PAVR 
Percutaneous Aortic Valve Replacement 
PMA 
Premarket Approval 
PVD 
Peripheral Vascular Disease 
PVL 
Paravalvular Leak 
RA 
Right Atrium 
RV 
Right Ventricular 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 93 of 211  
Abbreviation 
Term 
SAV 
Surgical Aortic Valve 
SAVR 
Surgical Aortic Valve Replacement 
SD 
Standard Deviation 
SJM 
St. Jude Medical, Cardiovascular Division 
SSC 
Subject Selection Committee 
STS 
Society of Thoracic Surgeons 
TA 
Trans Apical 
TAV 
Transcatheter Aortic Valve 
TAVI 
Transcatheter Aortic Valve Implantation 
TAVR 
Transcatheter Aortic Valve Replacement 
TEE 
Transesophageal Echocardiogram (same as TOE) 
TF 
Trans Femoral 
TIA 
Transient Ischemia Attack 
TAo 
Transaortic 
TTE 
Transthoracic Echocardiogram 
UADE 
Unanticipated Adverse Device Effect 
US 
United States (same as USA) 
USA 
United States of America (same as US) 
VARC 2 
Valve Academic Research Consortium 2 
VIV 
Valve in Valve 
WBC 
White Blood Cell 
WMA 
World Medical Association 
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 94 of 211  
Appendix B: Synopsis (Pivotal IDE) 
Study Title: 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE 
Trial (PORTICO) 
 
Study Number: 
1203 
 
Study Device: 
Portico™ Transcatheter Heart Valve and the Portico Delivery 
Systems 
Study Purpose:  
 
The Portico™ Transcatheter Aortic Heart Valve is indicated for patients with symptomatic 
severe native aortic stenosis, who are considered high surgical or extreme surgical risk. 
 
Primary Endpoints  
 
Effectiveness endpoint: the composite endpoint of all-cause mortality or disabling stroke 
at one year.  
Safety Endpoint: Non-hierarchical composite of all-cause mortality, disabling stroke, life 
threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, 
or major vascular complications at 30 days. 
 
Secondary Endpoints  
 
1. Severe aortic regurgitation (AR) at one year 
2. Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year 
3. Moderate or severe aortic regurgitation at one year 
4. Six minute walk at one year 
 
 Descriptive Endpoints  
1. Acute device success defined as: 
o Absence of procedural mortality AND 
o Correct positioning of a single prosthetic heart valve into the proper 
anatomical location AND 
o Intended performance of the prosthetic heart valve (mean aortic valve 
gradient <20 mmHg or peak velocity <3 m/s, no moderate or severe 
prosthetic valve regurgitation) AND 
o Successful access was obtained as intended by group assignment 
2. Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year for Centers 
for Medicare and Medicaid Services (CMS) National Coverage Decision 
primary quality of life endpoint. 
3. Major vascular complications at 30 days from the index procedure 
4. NYHA functional classification at 30 days, 6 months, and one year 
5. Six minute walk test at 30 days, 6 months, and one year 
6. Paravalvular Leak (PVL) at 30 days, 6 months, and one year 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 95 of 211  
7. Aortic insufficiency greater than trace at 30 days, 6 months, one year, and two 
years 
8. Reintervention to treat aortic insufficiency at one year and two years 
9. Permanent pacemaker insertion at 30 days from the index procedure  
10. Major bleeding at 30 days from the index procedure 
11. Acute kidney injury at 30 days from the index procedure 
12. Individual components of the primary effectiveness endpoint 
o All-cause mortality at 30 days, 6 months, one year and two years 
o Disabling stroke at 30 days, 6 months, one year and two years 
13. Non-Disabling Stroke and Transient Ischemic Attack (TIA) at 30 days, 6 
months, one year, and two years 
14. Atrial fibrillation at  one year and two years 
15. Quality of Life (QOL) from baseline at 30 days, 6 and one year 
 
Study Design  
 
The PORTICO pivotal IDE trial is a prospective, multi-center, randomized-controlled 
clinical study designed to evaluate the safety and effectiveness of the SJM Portico™ 
Transcatheter Aortic Heart Valve and Delivery Systems (Portico) via transfemoral and 
alternative delivery methods, in high risk and extreme risk cohorts.  
The pivotal IDE trial includes a randomized cohort, three nested registries (Roll-in, Valve-
in-Valve and Portico Extreme Risk (now closed to enrollment)) and a separate FlexNav 
study arm (under Protocol version L).  
For the randomized cohort, approximately 758 subjects will be enrolled from  up to 70 
investigational sites globally. 
Data from the randomized cohort and the FlexNav study will be used to support a PMA 
application for approval of the Portico™ Transcatheter Aortic Heart Valve and FlexNav™ 
Delivery System in the United States. Data of subjects enrolled in the registries will not 
be included in the randomized population nor the primary data analysis; however, the 
data will be analyzed and presented separately. 
 
Sponsor: 
 
St. Jude Medical (now Abbott) 
Attn:  Global Clinical Affairs, PORTICO Clinical Study 
5050 Nathan Lane North 
Plymouth, MN 55442 USA 
Tel 651.756.5400 
 
National Principal  
Greg Fontana, MD 
 
Investigators:   
Raj Makkar, MD  
 
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 96 of 211  
Study Contact: 
Angie Roach 
Clinical Program Director, Structural Heart – Transcatheter Aortic 
and Surgical Valves Abbott 
5050 Nathan Lane North 
Plymouth, MN  55442  
U.S.A. 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 97 of 211  
Appendix C: Definitions 
 
Source 
Definition 
Cardiovascular 
Mortality 
(VARC 2) 
Any one of the following criteria: 
• 
Death due to proximate cardiac cause (e.g. myocardial infarction, cardiac 
tamponade, worsening heart failure) 
• 
Death caused by non-coronary vascular conditions such as neurological events, 
pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other 
vascular disease 
• 
All procedure-related deaths, including those related to a complication of the 
procedure or treatment for a complication of the procedure 
• 
All valve-related deaths including structural or nonstructural valve dysfunction or 
other valve-related adverse events 
• 
Sudden or unwitnessed death 
• 
Death of unknown cause 
Myocardial  
Infarction 
(VARC 2) 
Peri-procedural MI (less than or equal to (≤) 72 h after the index procedure) 
New ischemic symptoms (e.g., chest pain or shortness of breath), or new ischemic signs 
(e.g. ventricular arrhythmias, new or worsening heart failure, new ST-segment changes, 
hemodynamic instability, or imaging evidence of new loss of viable myocardium or new 
wall motion abnormality),  
AND  
Elevated cardiac biomarkers within 72 h after the index procedure consisting of at least 
one sample post-procedure with a peak value exceeding 15x upper reference limit 
(troponin) or 5x for CK-MB. If cardiac biomarkers are increased at baseline (>99th 
percentile), a further increase of at least 50% post-procedure is required AND the peak 
value must exceed the previously stated limit. 
Spontaneous MI (greater than (>) 72 h after the index procedure) 
Any one of the following criteria: 
• Detection of rise and/or fall of cardiac biomarkers (preferably troponin) with at least 
one value above the 99th percentile URL, together with evidence of myocardial 
ischemia with at least one of the following: 
o Symptoms of ischaemia 
o ECG changes indicative of new ischemia [new ST-T changes or new Left Bundle 
Branch Block (LBBB)] 
o New pathological Q waves in at least two contiguous leads 
o Imaging evidence of new loss of viable myocardium or new wall motion 
abnormality 
• Sudden, unexpected cardiac death, involving cardiac arrest, often with symptoms 
suggestive of myocardial ischemia, and accompanied by presumably new ST-segment 
elevation, or new LBBB, and/or evidence of fresh thrombus by coronary angiography 
and/ or at autopsy, but death occurring before blood samples could be obtained, or at 
a time before the appearance of cardiac biomarkers in the blood. 
• Pathological findings of an acute myocardial infarction. 
Stroke 
(FDA/VARC 2) 
This study is following the FDA’s definition of Stroke per FDA’s Current Thinking 
Regarding Neurological Assessments for Transcatheter Valve Trials (Revised: 25 Aug 
2011) and VARC 2 (2012) 
  
1. Definitions:  
a. Stroke: Stroke is an acute episode of focal or global neurological dysfunction caused 
by the brain, spinal cord, or retinal vascular injury as a result of hemorrhage or 
infarction.  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 98 of 211  
Source 
Definition 
Subclassifications of stroke:  
i. Ischemic Stroke is defined as an acute symptomatic episode of focal cerebral, 
spinal, or retinal dysfunction caused by an infarction of central nervous system 
tissue.  
ii. Hemorrhagic Stroke is defined as an acute symptomatic episode of focal or 
global cerebral or spinal dysfunction caused by a nontraumatic 
intraparenchymal, intraventricular, or subarachnoid hemorrhage.  
Stroke Disability (consistent with VARC 2 Definitions):  
i. Disabling:  an mRS score of 2 or more at 90 days and an increase of at least one 
mRS category from an individual’s pre-stroke baseline 
ii. Non-disabling:  an mRS score of < 2 at 90 days or one that does not result in an 
increase of at least one mRS category from an individual’s pre-stroke baseline 
b. Cerebral Infarction: Evidence of brain cell death from imaging studies or pathological 
examination. If there are clinical symptoms, then it is a stroke; otherwise, it is an 
asymptomatic cerebral infarction.  
c. Transient Ischemic Attack (TIA): A transient (less than (<) 24 hrs) episode of 
neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, 
without acute infarction. No evidence of infarction if imaging performed.  
d. Encephalopathy: Altered mental state (e.g., seizures, delirium, confusion, 
hallucinations, dementia, coma, psychiatric episode, etc.).  
e. Intracranial Hemorrhage: Collection of blood between the brain and skull. 
Subcategorized as epidural, subdural, and subarachnoid bleeds.  
 
Bleeding 
(VARC 2) 
 
Life-threatening or disabling bleeding 
• Fatal bleeding (BARC type 5) OR 
• Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial 
necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC 
type 3b and 3c) OR 
• Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or 
surgery (BARC type 3b) OR 
• Overt source of bleeding with drop in hemoglobin of greater than or equal to (≥) 5 g/dl 
or whole blood or packed red blood cells (RBCs) transfusion greater than or equal to (≥) 
4 U (BARC type 3b). Given 1 U of packed RBC typically will raise blood hemoglobin 
concentration by 1 g/dl, an estimated decrease in hemoglobin will be calculated. 
 
Major bleeding (BARC type 3a) 
• Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0 g/dl 
or requiring transfusion of two or three units of whole blood/ RBC, or causing 
hospitalization or permanent injury, or requiring surgery AND 
• Does not meet criteria of life-threatening or disabling bleeding  
 
Minor bleeding (BARC type 2 or 3a, depending on the severity) 
• Any bleeding worthy of clinical mention (e.g., access site hematoma) that does not 
qualify as life-threatening, disabling or major 
 
Acute Kidney 
Injury (AKIN 
Classification) 
(VARC 2) 
Change in serum creatinine (up to 48 h) compared with baseline 
 
Stage 1  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 99 of 211  
Source 
Definition 
Increase in serum creatinine to 150% to 199% (1.5 to 1.99 X increase compared with 
baseline) or increase of greater than or equal to (≥) 0.3 mg/dl (≥26.4 mmol/l) or 
Urine output <0.5 ml/kg per hour for > 6 but < 12 hours 
 
Stage 2  
Increase in serum creatinine to 200% to 299% (2.0 to 2.99 X increase compared with 
baseline) or  
Urine output <0.5 ml/kg per hour for > 12 but < 24 hours 
 
Stage 3  
Increase in serum creatinine to greater than or equal to (≥) 300% (>)3 X increase 
compared with baseline) or serum creatinine of ≥ 4.0 mg/dl (≥354 mmol/l) with an acute 
increase of at least 0.5 mg/dl (44 mmol/l) or Urine output < 0.3 ml/kg per hour for > 24 
hours or anuria for > 12 hours. Patients receiving renal replacement therapy are 
considered to meet Stage 3 criteria irrespective of other criteria. 
Vascular 
Access Site 
and Access-
Related 
Complications 
(VARC 2) 
Major vascular complications 
• 
Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or 
new apical aneurysm/pseudo-aneurysm or 
• 
Access site or access-related vascular injury (dissection, stenosis, perforation, 
rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve 
injury, compartment syndrome, percutaneous closure device failure) leading to 
death, life-threatening or major bleeding*, visceral ischaemia or neurological 
impairment or 
• 
Distal embolization (non-cerebral) from a vascular source requiring surgery or 
resulting in amputation or irreversible end-organ damage or 
• 
The use of unplanned endovascular or surgical intervention associated with death, 
major bleeding, visceral ischaemia or neurological impairment or 
• 
Any new ipsilateral lower extremity ischemia documented by patient symptoms, 
physical exam, and/or decreased or absent blood flow on lower extremity angiogram 
or 
• 
Surgery for access site-related nerve injury or 
• 
Permanent access site-related nerve injury  
Minor vascular complications 
• 
Access site or access-related vascular injury (dissection, stenosis, perforation, 
rupture, arterio-venous fistula, pseudoaneuysms, hematomas, percutaneous closure 
device failure) not leading to death, life-threatening or major bleeding*, visceral 
ischaemia or neurological impairment or 
• 
Distal embolization treated with embolectomy and/or thrombectomy and not 
resulting in amputation or irreversible end-organ damage or 
• 
Any unplanned endovascular stenting or unplanned surgical intervention not 
meeting the criteria for a major vascular complication or 
• 
Vascular repair or the need for vascular repair (via surgery, ultrasound-guided 
compression, transcatheter embolization, or stent-graft) or 
 
 
Percutaneous closure device failure 
Failure of a closure device to achieve haemostasis at the arteriotomy site leading to 
alternative treatment (other than manual compression or adjunctive endovascular 
ballooning) 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 100 of 211  
Source 
Definition 
 
Acute Device 
Success 
(VARC 2 with 
modifications) 
1. Acute device success defined as: 
o 
Absence of procedural mortality 
o 
Correct positioning of a single prosthetic heart valve into the proper anatomical 
location 
o 
Intended performance of the prosthetic heart valve (mean aortic valve gradient 
<20 mmHg or peak velocity <3 m/s, no moderate or severe prosthetic valve 
regurgitation) 
o 
Successful access was obtained as intended by group assignment 
Device success is a ‘technical’ composite endpoint meant to characterize the acute 
device and procedural factors which underlie vascular access, delivery, and performance 
of the TAVI system. Echocardiography should be routinely utilized as the standard for 
measuring prosthetic valve stenosis and regurgitation immediately after TAVI, and should 
always be performed in a resting state, either within 24–48 h after the index procedure 
or before hospital discharge. 
FDA 
Individual Patient Success 
1. Acute device success 
2. Discharged alive from the hospital without device-related major AEs (Includes AI ≤ 
1+) 
3. Survival to one year with:  
o 
No disabling stroke  
o 
No device-or procedure-related mortality  
o 
NYHA class ≤ 2, or improvement in NYHA class by at least 1 level from 
baseline 
o 
No re-hospitalizations for valve related complications/dysfunction or 
CHF due to aortic valve related causes 
4. No pacemaker dependency at 1 year (Excluding subjects with pre-procedural 
conduction abnormalities) 
Prosthetic 
Valve Stenosis 
Criteria 
In conditions 
of normal or 
near normal 
stroke volume 
(50–70 ml). 
(VARC 2) 
 
Parameter  
Normal 
Mild Stenosis 
Moderate/ 
severe 
Stenosis 
Peak velocity (m/s) 
less than (<) 3 
3–4 
greater than 
(>) 4 
Mean gradient (mm Hg) 
less than (<) 20 
20–40 
greater than 
(>) 40 
Doppler velocity index 
greater than or equal 
to (≥) 0.35 
0.35–0.25 
less than (<) 
0.25 
Effective orifice area 
(cm2) 
greater than (>) 1.1 
1.1–0.8 
less than (<) 
0.80 
Prosthetic 
Valve 
Regurgitation 
Criteria  
(VARC 2) 
Diastolic flow reversal in the descending aorta (semi-quantitative parameters) 
Diastolic flow 
reversal in the 
descending aorta  
PW Doppler 
Absent or brief early 
diastolic 
Intermediate 
Prominent, 
holodiastolic 
                                                     
 
 Effective orifice area (EOA) used in this protocol is 1.0 cm2 for Portico valve of 23mm diameter. 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 101 of 211  
Source 
Definition 
Circumferential 
extent of 
paraprosthetic AR 
less than (<) 10% 
10–29% 
greater than 
or equal (>) 
30% 
Doppler parameters (quantitative) 
Regurgitant volume 
(ml/beat) 
less than (<) 30% 
30–59% 
greater than 
or equal (>) 
60% 
Regurgitant fraction 
less than (<) 30% 
30–49% 
greater than 
or equal (>) 
50% 
EROA (cm2) 
0.10 cm2 
0.10-0.29 cm2 
≥0.30 cm2 
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 102 of 211  
Appendix D: Surgical Risk Assessment Tools 
This clinical study requires the use of two surgical risk assessment tools: 
1. The Society of Thoracic Surgeons’ (STS) risk calculation tools, Version 2.73 
(http://riskcalc.sts.org/STSWebRiskCalc273/de.aspx) 
2. Euro SCORE II (http://euroscore.org/calc.html) 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 103 of 211  
SAMPLE 
Appendix E: Quality of Life – EQ-5D 3L 
 
By placing a checkmark in one box in each group below, please indicate which statements 
best describe your own health state today. 
Mobility 
I have no problems in walking about 
 
❑ 
I have some problems in walking about 
 
❑ 
I am confined to bed 
 
❑ 
Self-Care 
I have no problems with self-care 
 
❑ 
I have some problems washing or dressing myself 
 
❑ 
I am unable to wash or dress myself 
 
❑ 
Usual Activities (e.g. work, study, housework, family or leisure activities) 
I have no problems with performing my usual activities 
 
❑ 
I have some problems with performing my usual activities 
 
❑ 
I am unable to perform my usual activities 
 
❑ 
Pain/Discomfort 
I have no pain or discomfort 
 
❑ 
I have moderate pain or discomfort 
 
❑ 
I have extreme pain or discomfort 
 
❑ 
Anxiety/Depression 
I am not anxious or depressed 
 
❑ 
I am moderately anxious or depressed 
 
❑ 
I am extremely anxious or depressed 
 
❑ 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 104 of 211  
To help people say how good or bad a health state is,  
we have drawn a scale (rather like a thermometer) on 
which the best state you can imagine is marked 100 and 
the worst state you can imagine is marked 0. 
  
 
 
9 0 
8 0 
7 0 
6 0 
5 0 
4 0 
3 0 
2 0 
1 0 
100 
Worst 
imaginable 
health state 
0 
Best  
imaginable 
health state 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 105 of 211  
Appendix F: Quality of Life – SF-36v2 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 106 of 211  
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 107 of 211  
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 108 of 211  
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 109 of 211  
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 110 of 211  
 
 
 
 
 
 
 
 
 
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 111 of 211  
Appendix G: Quality of Life – Kansas City Cardiomyopathy Questionnaire (KCCQ) 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 112 of 211  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 113 of 211  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 114 of 211  
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 115 of 211  
Appendix H: Mini-Mental State Examination (MMSE-2) 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 116 of 211  
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 117 of 211  
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 118 of 211  
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 119 of 211  
Appendix I: Canadian Cardiovascular Society grading of angina pectoris 
Grade I  
 
Ordinary physical activity does not cause angina, such as walking and 
climbing stairs. Angina with strenuous or rapid or prolonged exertion 
at work or recreation  
 
Grade II 
Slight limitation of ordinary activity. Walking or climbing stairs rapidly, 
walking uphill, walking or stair climbing after meals, or in cold, or in 
wind, or under emotional stress, or only during the few hours after 
awakening. Walking more than two blocks on the level and climbing 
more than one flight of ordinary stairs at a normal pace and in normal 
conditions  
 
Grade III 
 
Marked limitation of ordinary physical activity. Walking one or two 
blocks on the level and climbing one flight of stairs in normal 
conditions and at normal pace 
 
Grade IV 
 
Inability to carry on any physical activity without discomfort, anginal 
syndrome may be present at rest 
 
  
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 120 of 211  
Appendix J: Frailty Assessment 
The Frailty Index Data Collection Form will be used as an assessment tool to determine if 
frailty is a high risk factor for subjects prior to enrollment. This assessment will be 
performed after the informed consent has been obtained and prior to procedure. The 
assessment can be administered by either an investigator or research coordinator. 
The frailty assessment consists of three evaluations: 
1. Katz Index of Independence in Activities of Daily Living  
2. Grip Strength 
3. 15 Foot walk test 
 
Katz Index of Independence in Activities of Daily Living Activities  
 
Points (1 or 0)  
Independence 
(1 Point) 
NO supervision, direction or personal 
assistance 
Dependence 
(0 Points) 
WITH supervision, direction, 
personal assistance or total care 
BATHING  
Points: ________  
(1 POINT) Bathes self completely or needs 
help in bathing only a single part of the 
body such as the back, genital area or 
disabled extremity  
(0 POINTS) Need help with bathing 
more than one part of the body, 
getting in or out of the tub or shower. 
Requires total bathing  
DRESSING  
Points: ________  
(1 POINT) Get clothes from closets and 
drawers and puts on clothes and outer 
garments complete with fasteners. May 
have help tying shoes.  
(0 POINTS) Needs help with dressing 
self or needs to be completely 
dressed.  
TOILETING  
Points: ________  
(1 POINT) Goes to toilet, gets on and off, 
arranges clothes, cleans genital area 
without help. 
(0 POINTS) Needs help transferring to 
the toilet, cleaning self or uses 
bedpan or commode. 
TRANSFERRING  
Points: ________  
(1 POINT) Moves in and out of bed or chair 
unassisted. Mechanical transfer aids are 
acceptable. 
(0 POINTS)Needs help in moving from 
bed to chair or requires a complete 
transfer. 
CONTINENCE  
Points: ________  
(1 POINT) Exercises complete self control 
over urination and defecation.  
(0 POINTS) Is partially or totally 
incontinent of bowel or bladder.  
FEEDING  
Points: ________  
(1 POINT) Gets food from plate into 
mouth without help. Preparation of food 
may be done by another person.  
(0 POINTS) Needs partial or total help 
with feeding or requires parenteral 
feeding.  
 
TOTAL Points:______________ 
 
 
Grip strength   Subjects elbow should be at a 90 degree angle without arm supported or 
resting on table or against chest wall. Each grasp should be completed with the 
dynamometer in the dominant hand. 
 
Grasp 1____________ 
Grasp 2___________ Grasp3____________   
Average_____________ 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 121 of 211  
15 Foot Walk    _______________seconds 
   
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 122 of 211  
Appendix K: Structured Interview for the Modified Rankin Scale (mRS) 
After the NIHSS has been completed, the mRS (by a certified rater) is to be determined 
and graded by the same certified rater. 
The determination of the scale should be made from 5 to 0, i.e., the order presented.  
The purpose of the mRS is to record whether the patient is dead, severely, moderately, 
or slightly disabled and if not dead or disabled, whether the patient is performing all 
usual activities without symptoms or not. Because subjects and family members may 
understate the severity of disability, it is important for the rating clinician to understand 
that the mRS is a clinical scale and not a patient-reported outcome. The rater may ask 
questions but must assess the disability whether or not in agreement with the subject or 
family.  
 “Improving the assessment of outcomes in stroke: use of a structured interview to 
assign grades on the Modified Rankin Scale” Stroke; 33:2243-2246) 
5: Severe disability; someone needs to be available at all times; care may be provided by 
either a trained or an untrained caregiver.  
Question: Does the person require constant care?  
4: Moderately severe disability; need for assistance with some basic activities of daily 
living (ADL), but not requiring constant care.  
Question: Is assistance essential for eating, using the toilet, daily hygiene, or walking?  
3: Moderate disability; need for assistance with some instrumental ADL but not basic 
ADL.  
Question: Is assistance essential for preparing a simple meal, doing household chores, 
looking after money, shopping, or traveling locally?  
2: Slight disability; limitations in participation in usual social roles, but independent for 
ADL.  
Questions: Has there been a change in the person’s ability to work or look after others if 
these were roles before stroke? Has there been a change in the person’s ability to 
participate in previous social and leisure activities? Has the person had problems with 
relationships or become isolated?  
1_No significant disability; symptoms present but not other limitations.  
Question: Does the person have difficulty reading or writing, difficulty speaking or 
finding the right word, problems with balance or coordination, visual problems, 
numbness (face, arms, legs, hands, feet), loss of movement (face, arms, legs, hands, 
feet), difficulty with swallowing, or other symptom resulting from stroke?  
0_No symptoms at all; no limitations and no symptoms.  
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 123 of 211  
Appendix L: Explant, Return, and Analysis of Valve 
The disposition of explanted valves warrants special consideration, as their proper return 
will allow for analyses providing valuable information. 
Clinical Study Sites’ Responsibilities for Explant and Return of Device:  SJM requests that 
all valves that are explanted or recovered be returned to SJM as follows: 
 
➢ Contact the SJM Project Manager(s) for this study as soon as it is learned that a valve 
will be explanted, or recovered during an autopsy. The Clinical Representative(s) will 
obtain a RA# (used for returning products to SJM), and then send a St. Jude Medical 
Product Return Kit to the site for return of the explanted valve. 
➢ When possible, take in situ photographs of the valve. 
➢ Remove the valve from the subject and immediately place it in the inner jar of the 
product return kit. (If the explant kit is not available, place the valve in any specimen 
jar until the product return kit arrives.) 
➢ Cover the valve with a formalin solution (usual lab concentration 3-8%). If an alternate 
solution is used [i.e., alkaline glutaraldehyde (Cidex) at 0.5-1% concentration], please 
indicate the solution type and concentration on the specimen container. 
➢ Secure the cap. 
➢ Complete the round white label with device, subject, and surgeon information. 
➢ Place the completed label on the cap of the inner jar and fold tape edges down over 
jar. 
➢ Place the small labeled jar in the absorbent wrapping provided, and place inside the 
larger jar. 
➢ Secure the cap. 
➢ Place the outer jar into the shipping box. Tape the box closed. 
➢ Write the RA#, and the name and phone number of the person responsible for 
shipping the valve on the return shipping label. 
➢ For infectious specimens, complete the highlighted portions of the Shipper’s 
Declaration for Dangerous Goods form, and keep this form with the product return 
kit. 
➢ Send the packaged valve, in situ photographs, and operative/autopsy notes via courier 
to the following address: 
St Jude Medical (now Abbott) 
Attn: Clinical Returns 
2305 Walnut St 
Roseville, MN  55113  
St. Jude Medical’s Responsibilities for the Analysis of an Explanted and Returned Device: 
 
SJM TAVR valves that are explanted or recovered at autopsy and returned will, upon 
receipt at St. Jude Medical, Inc., be evaluated according to documented SJM procedures. 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 124 of 211  
Appendix M: Instructions for Packaging and Returning Products to St. Jude Medical 
(now Abbott)  
St. Jude Medical provides instructions and a Device Return Kit (DRK) for components 
being returned for analysis. Please follow these instructions when returning products. 
1- Email the completed product Complaint and Event Form or Field Experience Report. 
Please submit event within 2 calendar days of becoming aware of the event. 
2- Clearly print the RGA number in the designated space on the event report form. 
3- Package device to be returned in DRK as follows: 
a. Insert hands into rubber gloves as provided in the DRK 
b. With gloved hands, place device to be retuned into zip lock bag and seal shut. 
c. Carefully position the sealed zip lock bag and device into the bio-hazard bag 
without damaging returned components. 
d. Place absorbent strip into bio-hazard bag. 
e. Follow instructions on the front facing bag to seal biohazard bag. 
f. Place plastic biohazard bag inside the Tyvek envelope (follow instructions on the 
outside of the Tyvek envelope). 
g. Assemble the box provided in the DRK following the directions on the box. 
h. Place the Tyvek envelope with the sealed biohazard pouch into box, again being 
careful not to damage 
i. Close box using the instructions provided on the panel of the box and seal with 
Chem-Tran Box Sealing. 
j. Affix UN3373 Label to the area as shown on the outer shipping box. 
4- Clearly print the RGA number on the outer portion of the DRK box. 
5- Affix the address label provided to the outside of the box and return DRK to the 
sponsor: 
 
St. Jude Medical (now Abbott) 
ATTN: Clinical Returns 
2305 Walnut St 
Roseville, MN 55113 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 125 of 211  
Appendix N: NYHA Classification 
 
Class I 
Patient has cardiac disease but without resulting limitations of 
ordinary physical activity. Ordinary physical activity (e.g., walking 
several blocks or climbing stairs) does not cause undue fatigue, 
palpitation, dyspnea, or anginal pain. Limiting symptoms may occur 
with marked exertion. 
 
Class II  
 Patient has cardiac disease resulting in slight limitation of ordinary 
physical activity. Patient is comfortable at rest. Ordinary physical 
activity such as walking more than two blocks or climbing more than 
one flight of stairs results in limiting symptoms (e.g., fatigue, 
palpitation, dyspnea, or anginal pain). 
 
Class III 
 
 Patient has cardiac disease resulting in marked limitation of physical 
activity. Patient is comfortable at rest. Less than ordinary physical 
activity (e.g., walking one to two level blocks or climbing one flight of 
stairs) causes fatigue, palpitation, dyspnea, or anginal pain. 
 
Class IV 
Patient has dyspnea at rest that increases with any physical activity. 
Patient has cardiac disease resulting in inability to perform any 
physical activity without discomfort. Symptoms may be present even 
at rest. If any physical activity is undertaken, discomfort is increased. 
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 126 of 211  
Appendix O: ATS Guidelines for the Six Minute Walk Test 
This Six Minute Walk (6MWT) Test measures the distance that a patient can quickly walk 
on a flat, hard surface in a period of 6 minutes. It evaluates the global and integrated 
responses of all the systems involved during exercise, including the pulmonary and 
cardiovascular systems, systemic circulation, peripheral circulation, blood, 
neuromuscular units, and muscle metabolism. It does not provide specific information 
on the function of each of the different organs and systems involved in exercise or the 
mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise 
testing. 
 
SAFETY ISSUES  
1. Testing should be performed in a location where a rapid, appropriate response to 
an emergency is possible. The appropriate location of a crash cart should be 
determined by the physician supervising the facility.  
2. Supplies that must be available include oxygen, sublingual nitroglycerine, aspirin, 
and albuterol (metered dose inhaler or nebulizer). A telephone or other means 
should be in place to enable a call for help.  
3. The technician should be certified in cardiopulmonary resuscitation with a minimum 
of Basic Life Support by an American Health Association–approved cardiopulmonary 
resuscitation course. Advanced cardiac life support certification is desirable. 
Training, experience, and certification in related health care fields (registered nurse, 
registered respiratory therapist, certified pulmonary function technician, etc.) are 
also desirable. A certified individual should be readily available to respond if 
needed.  
4. Physicians are not required to be present during all tests. The physician ordering the 
test or a supervising laboratory physician may decide whether physician attendance 
at a specific test is required.  
5. If a patient is on chronic oxygen therapy, oxygen should be given at their standard 
rate or as directed by a physician or a protocol. 
Reasons for immediately stopping a 6MWT include the following: (1) chest pain, (2) 
intolerable dyspnea, (3) leg cramps, (4) staggering, (5) diaphoresis, and (6) pale or ashen 
appearance.  
Technicians must be trained to recognize these problems and the appropriate 
responses. If a test is stopped for any of these reasons, the patient should sit or lie 
supine as appropriate depending on the severity or the event and the technician's 
assessment of the severity of the event and the risk of syncope. The following should be 
obtained based on the judgment of the technician: blood pressure, pulse rate, oxygen 
saturation, and a physician evaluation. Oxygen should be administered as appropriate.  
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 127 of 211  
CONTRAINDICATIONS  
Absolute contraindications for the 6MWT include the following: unstable angina during 
the previous month and myocardial infarction during the previous month. Relative 
contraindications include a resting heart rate of more than 120, a systolic blood pressure 
of more than 180 mm Hg, and a diastolic blood pressure of more than 100 mm Hg.  
Patients with any of these findings should be referred to the physician ordering or 
supervising the test for individual clinical assessment and a decision about the conduct 
of the test. The results from a resting electrocardiogram done during the previous 6 
months should also be reviewed before testing. Stable exertional angina is not an 
absolute contraindication for a 6MWT, but patients with these symptoms should 
perform the test after using their antiangina medication, and rescue nitrate medication 
should be readily available. A deviation from the Clinical Investigation Plan will need to 
be collected if the subject is unable to complete this test. 
LOCATION 
The 6MWT should be performed indoors, along a long, flat, straight, enclosed corridor 
with a hard surface that is seldom traveled. If the weather is comfortable, the test may 
be performed outdoors. The walking course must be 30 m in length. A 100-ft hallway is, 
therefore, required. The length of the corridor should be marked every 3 m. The 
turnaround points should be marked with a cone (such as an orange traffic cone). A 
starting line, which marks the beginning and end of each 60-m lap, should be marked on 
the floor using brightly colored tape.  
PROCEDURE 
REQUIRED EQUIPMENT  
• Countdown timer (or stopwatch)  
• Mechanical lap counter  
• Two small cones to mark the turnaround points  
• A chair that can be easily moved along the walking course  
• Worksheets on a clipboard  
• A source of oxygen  
• Sphygmomanometer  
• Telephone  
• Automated electronic defibrillator  
PATIENT PREPARATION  
• Comfortable clothing should be worn.  
• Appropriate shoes for walking should be worn.  
• Patients should use their usual walking aids during the test (cane, walker, etc.).  
• The patient's usual medical regimen should be continued.  
• A light meal is acceptable before early morning or early afternoon tests.  
• Patients should not have exercised vigorously within 2 hours of beginning the test.  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 128 of 211  
• This test should be performed about the same time of day for each interval to 
minimize intraday variability.  
• A "warm-up" period before the test should not be performed.  
• The patient should sit at rest in a chair, located near the starting position, for at 
least 10 minutes before the test starts. During this time, check for 
contraindications, measure pulse and blood pressure, and make sure that clothing 
and shoes are appropriate. Complete the first portion of the worksheet. 
Baseline Measurements 
1. Set the lap counter to zero and the timer to 6 minutes. Assemble all necessary 
equipment (lap counter, timer, clipboard, Borg Scale, worksheet) and move to the 
starting point.  
Instruct the patient as follows:  
“The object of this test is to walk as far as possible for 6 minutes. 
You will walk back and forth in this hallway. Six minutes is a long 
time to walk, so you will be exerting yourself. You will probably get 
out of breath or become exhausted. You are permitted to slow 
down, to stop, and to rest as necessary. You may lean against the 
wall while resting, but resume walking as soon as you are able.  
You will be walking back and forth around the cones. You should 
pivot briskly around the cones and continue back the other way 
without hesitation. Now I'm going to show you. Please watch the 
way I turn without hesitation." 
Demonstrate by walking one lap yourself. Walk and pivot around a cone briskly.  
"Are you ready to do that? I am going to use this counter to keep 
track of the number of laps you complete. I will click it each time 
you turn around at this starting line. Remember that the object is to 
walk AS FAR AS POSSIBLE for 6 minutes, but don't run or jog.  
Start now, or whenever you are ready."  
Position the patient at the starting line. You should also stand near the starting line 
during the test. Do not walk with the patient. As soon as the patient starts to walk, start 
the timer.  
Do not talk to anyone during the walk. Use an even tone of voice when using the 
standard phrases of encouragement. Watch the patient. Do not get distracted and lose 
count of the laps. Each time the participant returns to the starting line, click the lap 
counter once (or mark the lap on the worksheet). Let the participant see you do it. 
Exaggerate the click using body language, like using a stopwatch at a race.  
After the first minute, tell the patient the following (in even tones):  
"You are doing well. You have 5 minutes to go."  
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 129 of 211  
When the timer shows 4 minutes remaining, tell the patient the following:  
"Keep up the good work. You have 4 minutes to go."  
 
When the timer shows 3 minutes remaining, tell the patient the following:  
"You are doing well. You are halfway done."  
 
When the timer shows 2 minutes remaining, tell the patient the following:  
"Keep up the good work. You have only 2 minutes left."  
 
When the timer shows only 1 minute remaining, tell the patient:  
"You are doing well. You have only 1 minute to go."  
 
Do not use other words of encouragement (or body language to speed up).  
 
If the patient stops walking during the test and needs a rest, say this:  
"You can lean against the wall if you would like; then continue 
walking whenever you feel able."  
 
Do not stop the timer. If the patient stops before the 6 minutes are up and refuses to 
continue (or you decide that they should not continue), wheel the chair over for the 
patient to sit on, discontinue the walk, and note on the worksheet the distance, the time 
stopped, and the reason for stopping prematurely.  
 
When the timer is 15 seconds from completion, say this:  
"In a moment I'm going to tell you to stop. When I do, just stop right 
where you are and I will come to you."  
 
When the timer rings (or buzzes), say this: "Stop!"  
 
Walk over to the patient. Consider taking the chair if they look exhausted. Mark the spot 
where they stopped. 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 130 of 211  
Appendix P: Barthel Index 
 
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 131 of 211  
 
 
 
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 132 of 211  
Appendix Q: Patient Informed Consent 
STUDY TITLE:  PORTICOTM RE-SHEATHABLE TRANSCATHETER AORTIC VALVE SYSTEM  
US PIVOTAL IDE TRIAL (PORTICO) 
  
Principal Investigator: <    >  
Hospital: <    >  
 
 
Address: <    > 
 
Phone: <    > 
Sponsor: 
 St. Jude Medical, Cardiology Division Inc is now part of Abbott. 
(hereinafter referred to as “Sponsor” or “St Jude Medical”) 
 
 
 
 
PART 1 
 
1. Invitation 
You are being invited to take part in a research study.  Before you decide, it is important 
for you to know why the research is being done and what it will involve.  Please take 
time to read the following information carefully.  Feel free to discuss it with others if you 
wish.  Ask us if there is anything that is not clear or if you want more information. Take 
your time to decide if you wish to participate. 
 
2. Purpose of the study 
The purpose of this study is to evaluate the safety and effectiveness of the new St Jude 
Medical Portico Transcatheter Heart Valve and delivery systems.  The study valve is 
made to replace your diseased aortic heart valve.  
 
3. Why have I been invited? 
You are being asked to take part in this research study because your doctors have 
decided that you may be a high or extreme risk candidate for aortic heart valve 
replacement through open heart surgery. At your request, your study doctor will notify 
your personal physician of your participation in this study. 
 
4. How many people will participate? 
This study will be conducted at up to seventy (70) centers globally, and will include a 
maximum of 758 randomized subjects (enrollment of randomized subjects ended in 
October 2017).  Additionally, up to 100 subjects will be enrolled in a Valve-in-Valve 
registry and up to 200 subjects in a separate FlexNav study. 
 
5. What is the device being tested? 
The Portico Transcatheter Heart Valve is an investigational device.  This means that the 
valve is being studied, and is not for sale in the United States. This study is collecting 
data on the valve and delivery system for review and approval by the Food and Drug 
Administration (FDA).  
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 133 of 211  
The Portico Transcatheter Heart Valve is a replacement heart valve that can be placed 
through a tube in your leg or through your chest. The valve is made of animal tissue and 
is on a stent, or scaffold, which holds the valve in position. The stent portion of the valve 
is made with Nitinol (metal with Nickel and Titanium).  Picture 1 below shows the 
Portico valve.  Picture 2 on page 6 shows the different ways the valve can be put in 
place. 
 
Picture 1: Portico Aortic Heart Valve 
 
 
 
 
This is for general educational purposes only and is not completely 
representative of what will be implanted 
 
 
 
 
The Portico Transcatheter Heart Valve is loaded into a delivery system which is part of 
the catheter used to help the study doctor place the valve in your heart.  The delivery 
system is about as big around as your ring finger.  The valve is put into the delivery 
system with a two-part funnel system which compresses the stent to fit inside the 
delivery system. 
 
While using echocardiography and fluoroscopy (angiogram pictures) the study doctor 
will position the valve in your heart.  After positioning the heart valve, the delivery 
system will slowly let the valve expand to the full size.   
 
The Portico Transcatheter Heart Valve is designed to have the capability to be released 
slowly in a controlled manner, be repositioned (should the need arise), be removed 
completely and another attempt made, and the final position can be checked 
thoroughly before final valve release (with normal new valve function during the 
assessment). 
 
6. Do I have to take part? 
No. Your participation in this study is entirely voluntary and you are under no pressure to 
take part. If you decide to participate in this study, but later change your mind, you can 
withdraw at any time without explanation and without any loss of medical care or benefits 
you would otherwise have received.  You can withdraw from this study without penalty, 
and withdrawal from this study will not jeopardize your future care or your relationship 
with the study doctor. If you withdraw from the study, you will be asked what the reason 
is for withdrawing from the study, but you do not have to answer.   
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 134 of 211  
If the study doctor has concerns about your participation, you will not be able to take 
part in the study.  The study doctor can also withdraw you from the study at any time.   
  
If you do decide to take part, you will be asked to sign this consent form. By consenting 
to take part in this study you are agreeing that the St Jude Medical Portico valve (Picture 
1) may be implanted using the delivery system.  
 
7.  What are the alternate treatments? 
If you do not wish to take part in this study, your study doctor may treat your aortic 
valve with: 
1. Medication 
2. An FDA approved Transcatheter Aortic Valve Replacement (TAVR) valve and 
delivery system  
3. Standard open heart surgery by a referral to a heart surgeon  
 
8. How long will my participation last in this clinical study? 
Your participation in this study will begin when you sign the informed consent form and 
for up to five years following your implant, unless it is determined that you do not meet 
the study eligibility criteria or you decide to stop your participation in the study.   
 
If you are randomized in the study and do not receive a TAVR valve, you will be followed 
through the one-year visit, as part of the primary analysis intent to treat (ITT) population, 
and then withdrawn from the study. If you are enrolled in a registry or the FlexNav study  
and do not receive a Portico valve, you will be followed for any adverse events through 
the 30 days post procedure and then withdrawn from the study.  
 
If you undergo study-specific testing, but are not randomized you will be followed for any 
adverse events for 30 days from informed consent and then withdrawn from study 
participation. If you undergo study-specific testing,  but are not assigned to a registry or 
enrolled in the FlexNav study you will not be required to return for any follow-up. 
 
You may stop your participation in this study at any time.  Your participation in this study 
may also be stopped by St Jude Medical or by your study doctor.  
 
Reasons for ending your participation in the study by the Principal Investigator include, 
but are not limited to, the following: 
 
• Study participation was not in your best interest  
• You did not meet the inclusion/exclusion criteria  
• You and/or family request, if applicable 
• You aren’t able to comply with the requirement of the study (e.g., you 
aren’t able to attend follow-up visits) 
• Death   

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 135 of 211  
• Your non-compliance with study requirements 
• You are considered “lost to follow-up”, which occurs after a minimum of 3 
documented phone calls of a physician or designee at the study site to the 
subject or emergency contact and a letter sent to the last known address 
by traceable mail  
• Your participation is terminated by the Principal Investigator if it is not in 
your best interest to continue in the study 
• Study discontinued due to St Jude Medical management decision or 
request from applicable governing bodies 
• Investigational site ends participation in the study 
 
The study may be temporarily stopped or terminated, either at the local or national level, 
at the request of the Institutional Review Board (IRB), regulatory authorities (FDA), or St 
Jude Medical.   
St Jude Medical may stop the study if new information about the device is learned during 
the duration of the study to ensure patient safety.  
You will be notified in writing if there are new findings or reasons for any changes to the 
study plan which will affect your continued participation in the study.  
 
9. What will take place during the study? 
 
This is a randomized research study. “Randomized” means that you will be assigned to a 
study group by chance, like flipping a coin.  Depending on your valve size you will be 
randomized into one of two study groups which will determine the device you are 
implanted with: 
 
• Test Group:  Portico Transcatheter Heart Valve 
• Control Group:  FDA-approved Transcatheter Heart Valve 
 
Note: The randomized cohort completed enrollment in October 2017. 
 
There are also two (2) registries and a separate FlexNav study group (which uses  a new 
delivery system)  in this research study. If you are placed in a registry or the FlexNav 
study you will receive a Portico valve rather than be randomized.  
 
The first registry is called a roll-in registry. You may be considered for this registry based 
on your order of enrollment in the study. All those placed in this registry will receive a 
Portico valve. The second registry is for those who have already received a replacement 
surgical aortic valve and require another. If you qualify for this registry, a Portico valve 
will be implanted inside your existing surgical valve. 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 136 of 211  
The FlexNav study will evaluate the safety of the new FlexNav™ Delivery System. All 
those assigned to the study group will receive a Portico valve using the new delivery 
system.   
 
There is no change in the intended use of the new delivery system compared to the 
first-generation Portico Delivery System. Modifications that have been made to the new 
FlexNav™ Delivery System are designed to reduce the overall size of the system, 
improve the doctor’s ability to position the heart valve, and promote overall ease of use. 
These design modifications do not alter the procedure to load or deploy the Portico 
valve.  
 
Before your operation: 
To determine if you qualify for the study, you may have the following tests performed, 
depending on your clinical condition.  None of these tests are considered experimental 
and would be part of your normal care even if you were not in the study: 
 
• Physical Exam: your study doctor or a trained member of his or her staff will ask 
you about your medical history and do a basic physical exam 
• CT Scan: a test to assess the blood vessels (ascending aorta, bilateral iliac arteries) 
of your body  
• Chest x-ray: An x-ray will be taken to assess any abnormalities in your chest.  This 
takes about 5 minutes to complete. 
• Echocardiography (echo): a test that uses sound waves to look at how your heart is 
functioning  
• Electrocardiogram (ECG):  a tracing of your hearts rhythm 
• Lab work: standard blood tests 
• Frailty Index:  an evaluation by your doctor used to predict your risk for medical 
procedures 
• NYHA Functional Classification and Angina Scale:  an evaluation by your study 
doctor to rank the limitations in your daily activities based on shortness of breath 
and chest pain 
• STS Risk Score/EuroSCORE II:  evaluations to measure the amount of risk surgery 
may pose to you 
• Pulmonary Function Test: a breathing test to check the function of your lungs 
• Coronary and Aortic Angiogram: a test to assess the blood vessels of your body 
 
If you do not meet all the criteria for the study, no further procedures will be 
performed. If you do meet all criteria for the study, and would like to participate, then 
you will complete the following tests prior to being randomized and scheduled for the 
procedure.  You may not have to repeat some tests that were performed during 
screening. You can change your mind even after signing this form; simply let the 
research staff know. The baseline tests include: 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 137 of 211  
• Lab work: standard blood tests 
• Quality of Life Questionnaires (QOL): you will be asked to complete questionnaires 
about your general health, and symptoms that you may or may not have 
• Medications: you will be asked the names of medications you are taking 
• 6 Minute Walk: you will be asked to walk for 6 minutes at your normal speed. The 
distance you walk and how you feel will be recorded. The purpose of this test is to 
measure how many feet you can walk in six minutes   
• Stroke Scales: scales used to measure the degree of disability or dependence in 
daily activities for people who have had a stroke.  This will be done for this study 
even if you have not had a stroke 
• Disability Scale: an evaluation to assess your physical functions, self-care and ability 
to get around 
• Mini-Mental State Exam: you will be asked to answer questions and to perform a 
few tasks to assess your thinking and memory 
 
During your procedure: 
The Portico Transcatheter Heart Valve implant will be done in the hospital 
catheterization laboratory, a special room for these kinds of procedures.  You may be 
given medication to make you sleepy and more comfortable during the procedure or 
you may be put fully asleep for the duration of the procedure.   
 
 
If your blood vessels are the right size and shape the study doctor will make an incision 
in your groin (upper part of your leg where it connects to your hip) and insert a catheter 
(small tube) into the opening made.  The catheter will be moved through your femoral 
(leg) artery (picture 2a) up to the heart and into position in the heart to allow placement 
of the valve. 
 
If your leg blood vessels are too small or diseased the study valve will be implanted 
through your chest (picture 2b), or through blood vessels near your shoulder (picture 2c 
or 2d) 
   
 
 
 
 
 
 
 
 
 
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 138 of 211  
Picture 2: Different Methods for Valve Implantation 
a
 
b 
 
 
c 
d 
 
 
a) transfemoral b) transaortic c) left subclavian d) left axillary (courtesy of Rodés-Cabau, J. Nat. Rev. 
Cardiol. 9, 15–29 (2012) 
 
The study doctor will use various special imaging methods such as angiographic pictures 
(x-ray picture of the coronary arteries) to check the position of the catheter and valve.  
Once the catheter and valve are in the correct position the study doctor will slide the 
valve out of the catheter and it will unpack and expand to form a replacement aortic 
valve.   
 
With the replacement valve in place, the study doctor will use echo and angiographic 
pictures to check that valve is working correctly.  When the study doctor has confirmed 
placement, the catheter will be removed and you will be taken to the recovery area.  
Following the procedure, if you had the valve placed through your leg, you will have 
pressure applied to the groin area and will be required to lay flat for a specified amount 
of time. If you had the valve placed through your chest, your doctor will determine your 
limitations.  
 
If the study doctor was unable to place the valve in your heart, you may need open 
heart surgery to replace the valve using standard surgical methods.   
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 139 of 211  
During the procedure, a representative of St Jude Medical may be in the procedure 
room to provide technical support on the device for your doctor.   
 
After your operation 
After your operation, you will be visited by the study doctor. The study doctor will be 
looking to see whether you have any complications from the procedure. Before you are 
discharged from the hospital the following will be done: 
 
• Physical Exam: your study doctor or a trained member of his/her staff will ask 
you about your medical history and do a basic physical exam 
• Echocardiography: a test that uses sound waves to look at how your heart is 
functioning. This test will be completed after the procedure or before you are 
discharged from the hospital. 
• Lab work: standard blood tests 
• Medications: you will be asked for the name of the medications you are taking 
• ECG: tracing of your heart rhythm 
• Stroke Scales: scales used to measure the degree of disability or dependence in 
daily activities for people who have had a stroke.  This will be done for this study 
even if you have not had a stroke 
• Assessment of changes in health status: you will be asked if there are any 
changes in your health status since you have had your heart valve replaced. Your 
health status assessment will continue throughout the course of your 
participation in this study. 
• Disability Scale: an evaluation to assess your physical functions, self-care and 
ability to get around 
• Angina Scale:  an evaluation by your study doctor to rank the limitations in your 
daily activities based on shortness of breath and chest pain 
 
Follow-up visits 
After the procedure, you will return to the study doctor’s office for follow-up visits at 30 
days, 6 months, and 12 months (one year) and yearly through five years after the 
procedure.  
 
At these visits the following will be done: 
• Physical Exam: your study doctor or a trained member of his/her staff will ask 
you about your medical history and do a basic physical exam 
• ECG:  tracing of your heart rhythm 
• Echocardiography: a test that uses sound waves to look at how your heart is 
functioning.   
• QOL: you will be asked to complete questionnaires about how you are feeling  
• Medications: you will be asked the names of medications you are taking 
• 6 Minute Walk: you will be asked to walk for 6 minutes at your normal speed. 
The distance you walk and how you feel will be recorded. The purpose of this 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 140 of 211  
test is to measure how many feet you can walk in six minutes. (This test will not 
be done at the annual visits past one year.)  
• Lab Work: standard blood tests (This will not be done at the yearly visits past one 
year.) 
• Assessment of changes in health status: you will be asked if there are any 
changes in your health status since you have had your heart valve replaced. Your 
health status assessment will continue throughout the course of your 
participation in this study. 
• Frailty Index:  an evaluation by your doctor used to predict your risk for medical 
procedures (This will not be done at the yearly visits past one year.) 
• Stroke Scales: scales used to measure the degree of disability or dependence in 
daily activities for people who have had a stroke.  This will be done for this study 
even if you have not had a stroke.  
• NYHA Functional Classification and Angina Scale:  evaluations by your study 
doctor to rank the limitations in your daily activities based on shortness of 
breath and chest pain 
• Mini-Mental State Exam: you will be asked to answer questions and to perform 
a few tasks to assess your thinking and memory (This will not be done at the 
annual visits past one year.) 
• Disability Scale: an evaluation to assess your physical functions, self-care and 
ability to get around  
• Angina Scale: an evaluation by your study doctor to rank the limitations in your 
daily activities based on shortness of breath and chest pain 
 
If you are one of the first approximately 500 subjects enrolled, you will have the 
following test performed at your 30-Day and 6-month follow-up visits: 
• Multi-Slice Computed Tomography (MSCT) Scan: a sophisticated x-ray machine that 
utilizes a liquid dye to produce sharp, detailed 3-D images of the heart and vessels.  
o If your doctor decides you are not a good candidate for the MSCT Scan, a 
Transesophageal Echocardiogram (TEE) test will be performed instead:  a 
type of echo test which provides a close look at the heart's valves and 
chambers, without interference from the ribs or lungs. 
 
Your doctor will inform you if you are part of this group undergoing the additional scans 
(Note: Participation in this group is now closed). 
 
If you have a suspected stroke or other neurological event, the following will be done at 
a visit 90 days after the event: 
• Neurological assessment:  an examination of how your brain functions to help 
determine if you may have had a stroke 
• Stroke Scales: scales used to measure the degree of disability or dependence in 
daily activities for people who have had a stroke.   

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 141 of 211  
 
10. Health Economic Analysis 
The Sponsor is also conducting a health economic analysis. The Health Economic 
Analysis will evaluate the costs and benefits of treatment. This information is being 
collected so we can understand the cost effects of the treatment in the PORTICO study. 
For the purpose of this Health Economic Analysis, information about your reported 
resource use of hospital care will be collected. Medical resource use, cost and health-
related quality of life within the trial period will be compared between study subject 
groups. 
 
11. Radiation exposure 
This study may involve radiation exposure from a CT or fluoroscopy. As part of everyday 
living, everyone is exposed to a small amount of background radiation. Background 
radiation comes from space and naturally-occurring radioactive minerals.  
 
The angiography procedure uses x-ray radiation to guide the examination.  The amount 
of radiation you are exposed to during this procedure will depend on the complexity of 
the procedure, but will range from the equivalent of 3 to 12 years of exposure to the 
natural background radiation to which we are all exposed.  In this research you will not 
be exposed to any additional radiation during the procedure, as you will undergo the 
same procedure regardless of whether or not you choose to participate in this research 
trial.  
 
The overall risk from this dose is considered small. A part of this radiation exposure 
would already be necessary for your medical care. 
 
12. Potential risks and side effects of transcatheter aortic valve implantation 
 
Possible risks and discomforts associated with the participation in this study will be 
similar as those associated with any routine transcatheter aortic valve implantation and 
related follow-up and may include, but are not limited to: 
 
Technical Name 
What it means 
Access site complications 
primarily relates to bruising or bleeding at the 
site where the delivery system was inserted 
Acute coronary obstruction 
blocking the arteries carrying blood to the 
heart 
Acute myocardial infarction 
heart attack 
Access site injury 
Injury during the process of inserting valve or 
the valve damages other parts of the body 
near it 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 142 of 211  
Technical Name 
What it means 
Allergic reaction to antiplatelet 
agents, contrast medium, 
anesthesia or valve components 
reaction to some medications, x-ray dye, 
procedural dye, or materials used to make the 
valve 
Anaphylactic shock/toxic reaction 
serious allergic reaction 
Annulus rupture 
tearing of the ring tissue around the heart 
valve 
Aortic rupture 
tearing of the aortic valve 
Ascending aortic trauma 
damage to the largest artery in your body. The 
artery is the main supply from the heart.  
Atrio-ventricular node block 
a slowed heart beat due to top and bottom 
chambers of your heart not beating normally 
together  
AV fistula 
abnormal connection between an artery or 
vein 
Bleeding 
an episode which involves bleeding 
Cardiac arrhythmia 
irregular heart beat 
Cardiovascular or vascular injury 
injury to blood vessels, heart  
Conduction system injury 
a change in the way your heart impulses are 
transmitted which may require a pacemaker 
insertion  
Death 
Death 
Endocarditis 
infection in the heart 
Embolism: air, calcification or 
thrombus 
clogging an artery or vein stopping blood flow 
to a body part 
Exercise intolerance (weakness) 
unable to exercise at your normal level of 
physical tolerance 
Fever 
elevated body temperature 
Heart failure 
heart cannot pump enough blood to the rest of 
the body 
Hematoma 
collection of blood outside a blood vessel 
Hemodynamic compromise 
problems with blood flow 
Hemolysis 
break down of the blood cells 
Hemolytic anemia 
abnormal breakdown of the red blood cells in 
your blood 
Hemorrhage 
excessive bleeding  
Hypertension 
blood pressure is too high 
Hypotension 
blood pressure is too low 
Immunological reaction 
disorder of the immune system 
Infection 
organisms in body causing abnormal body 
reactions or sickness 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 143 of 211  
Technical Name 
What it means 
Leakage, regurgitation 
some blood flows around the edges of the 
valve 
Left ventricular failure/rupture 
 
lower left chamber of your heart does not 
work correctly or tears 
Left ventricular impairment (due to 
apical scar) 
lower left chamber of your heart does not 
work correctly due to past damage  
Myocardial ischemia 
not enough blood flow to the heart muscle 
Mitral valve insufficiency 
heart valve does not close properly and leaks 
Multi-organ failure 
more than one body organ does not function 
Neurological changes including 
stroke/transient ischemic attack 
a blood clot travels to a vessel in your brain 
and blocks blood flow (stroke)/blood flow to a 
part of the brain stops for a brief period of 
time(tia) 
Non-structural dysfunction 
wrong size valve, suture or tissue gets in way 
of valve function 
Pannus 
abnormal layer of tissue 
Paravalvular leak 
some blood flows around the edges of the 
valve 
Pericardial effusion 
bleeding into the sac around the heart 
Perforation, of the myocardium or a 
blood vessel                                              
hole in blood vessel 
Potential coronary obstruction 
Coronary artery is blocked 
Renal failure 
kidneys not functioning to normal capacity 
Renal insufficiency 
poor kidney function 
Respiratory failure (shortness of 
breath) 
breathing difficulty requiring medical 
intervention 
Sepsis 
generalized overall systemic infection  
Septal rupture 
tear in the tissue which divides the heart 
chambers 
Stenosis (high gradient) 
a high amount of vessel narrowing  
Stroke 
a blood clot travels to a vessel in your brain 
and blocks blood flow 
Structural valve deterioration 
parts of valve do not work or do not work as 
expected 
Systemic peripheral ischemia 
inadequate blood flow 
Tamponade 
a large amount of fluid collects around the sac 
surrounding your heart  
Valve migration or malposition 
valve movement out of position 
Valve explant 
remove valve  
Valve embolization 
valve is not in contact with aortic annulus 
Valve stenosis 
narrowing of valve opening 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 144 of 211  
Technical Name 
What it means 
Valve thrombosis 
blood clot is attached to or near the valve 
Ventricular failure (acute) 
lower chamber of your heart is currently not 
functioning 
Ventricular rupture 
tear in the lower chamber of the heart 
Vessel dissection or spasm 
structure of vessel is changed 
 
 
It is possible these complications could lead to: 
• Transfusion 
• Conversion to open surgical procedure 
• Reoperation 
• Emergent balloon valvuloplasty 
• Emergent percutaneous coronary intervention (PCI) 
• Emergent surgery (i.e., coronary artery bypass, heart valve replacement) 
• Explantation 
• Permanent disability 
• Death 
• Permanent pacemaker 
Due to the nature of the delivery methods used, TAVR procedures may be associated 
with an increased risk of stroke and vascular complications when compared to surgical 
aortic valve replacement. 
 
A layer of thrombus (blood clot) has been seen on some TAVR valves when four-
dimensional computed tomography (4D CT) scans or transesophageal echocardiograms 
(TEE) are used to examine the valve after implant. In several cases, this layer of 
thrombus has been shown to prevent valve leaflets from opening properly. The layer of 
thrombus may be present but not seen if a 4D CT scan or TEE is not done. Blood thinners 
and anti-clot medicine can be used to treat the thrombus and may be prescribed by 
your study doctor even if no thrombus has been seen. 
 
The overall risk of death from transcatheter aortic valve implantation at this hospital at 
30 days is between <insert site risk>% (<>/100 to <>/100), depending on your other pre-
existing illnesses. 
 
There are additional risks for study related tests.  These risks may include but are not 
limited to the following: 
 
Six minute walk test:  the possible risks from this test are that you may experience 
fatigue, shortness of breath, chest pain and/or leg cramps.  This test is done under the 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 145 of 211  
supervision of a trained professional in a testing area where medical care is immediately 
available. The test will be immediately stopped if you experience chest pain, intolerable 
shortness of breath, leg cramps or pale appearance. 
 
Blood sample:  the risk of inserting a needle into a vein in your arm may include 
temporary discomfort from the needle stick.  There is also a small risk of infection, 
bruising, swelling, bleeding or fainting.  These risks are minimized by cleansing the site 
carefully prior to obtaining the blood sample and applying pressure to the site after the 
blood sample is obtained. 
 
Echocardiogram:  For a Transthoracic Echocardiogram (TTE), a lubricant (gel) is used on 
the skin to improve picture quality and this may feel cold.  There are no known risks 
associated with receiving a TTE echocardiogram. There may be discomfort from the 
pressure of the transducer as the images are taken. 
 
Another type of echocardiogram is called a Transesophageal Echocardiogram (TEE), 
which takes images by putting a scope down your throat while you are asleep. Some 
risks include, but are not limited to, esophageal bleeding, sore throat, and bruising. 
 
Your doctor will determine which echocardiograms are best to get the best images of 
your heart. 
 
CT/MSCT and Fluoroscopy:  There may be risks due to the radiation used during the CT 
and fluoroscopy scan. There is a risk that the contrast media/dye used during the 
CT/MSCT and fluoroscopy procedures could harm your kidneys or that you will have an 
allergic response.  In either case, your doctor will be prepared to treat you with 
medications.   
 
13. What are the risks for women of childbearing age? 
If you are pregnant or plan to become pregnant in the duration of the study, you should 
discuss your participation with your study doctor.  Subjects who become pregnant while 
taking part in the study should contact the study doctor right away. 
There could be other risks or discomforts to you (or to an embryo, unborn child or 
nursing infant if you become pregnant) that are not known at this time. You will be told 
in writing about any new information that may become available during your 
participation in the study or that may influence your decision to continue participation 
in this study. 
 
14. Potential Benefits of taking part in the study 
This study may not benefit you directly, but may benefit other patients with a similar 
condition in the future.  Such future benefits to other patients may possibly include: 
• Making the operation simpler by reducing the need for: 
o Open heart surgery  
o Use of the heart and lung machine 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 146 of 211  
• Fewer number of days spent in the hospital 
• Less risk of complications 
• Allowing a faster return to your normal activity level 
• Potential improvement in your heart function 
 
15. What if something goes wrong? 
Any complaint about the way you have been treated during the study, if you have any 
questions about your rights, or any possible harm you might suffer, talk to your study 
doctor or hospital patient advocate. 
 
16. Whom should I contact if I have questions or if I am injured during the study? 
During the course of this clinical study, if you have any further questions, concerns, or 
research related injuries as a result of your participation, please contact [add Principal 
Investigator contact information here]. 
 
For questions regarding your rights as a research subject, please contact the hospital 
ethics board (often called an IRB or Institutional Review Board) at [add IRB contact 
information here]. 
 
17. What will happen if I don’t want to carry on with the study?  
You can withdraw from the study at any time.  Feel free to inform the study staff of your 
decision to withdraw from the study even while you are being taken to the procedure 
room or are in the procedure room. If you decide not to participate in the study before 
the procedure, you will not get a St Jude Medical Portico valve.   
 
18. What if there is a problem? 
If you were to suffer harm of any kind as a direct result of this study, treatment for that 
injury including surgery, first aid, and emergency care will be available as applicable 
under Federal, State, and local law.  The hospital or clinic where you received treatment 
will bill your insurance company for the routine costs of care available under your health 
care plan and you may also have to pay some costs such as co-pays or deductibles. 
 
If you followed all study instructions and are hurt during the study as a direct result of 
the study device or study procedures (not part of your routine medical care), St. Jude 
Medical will pay for reasonable and necessary medical and hospital expenses.  
 
St. Jude Medical will not cover the cost of injuries to the extent that they are caused by 
your failure to follow study instructions or other negligence, or that of the hospital or 
study doctor, the natural progression of an underlying condition (whether diagnosed or 
not) or pre-existing condition, or events that would have been expected from the 
standard treatment using currently approved therapies for your condition. 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 147 of 211  
Signing this consent form in no way limits your legal rights against the Sponsor, 
investigators, or anyone else, and you do not release the study doctors or participating 
institutions from their legal and professional responsibilities. If you have a concern 
about any aspect of this study, you should ask to speak to the researchers at < Hospital> 
or <    >, MD who will do his best to answer your questions. 
 
In the event of your death, if you received a St. Jude Medical valve, your implanted valve 
may be removed and returned to St. Jude Medical for analysis.  The study doctor will get 
your family’s approval prior to removing the device.   
 
19. Will my taking part in this study be kept confidential? 
 If you decided to take part in this research study, your participation, medical records, and 
personal information will be kept confidential to the extent allowed by Federal, State, and 
local law.   However, research records and health or other source records identifying you 
may be inspected by the Sponsor (St Jude Medical) and its affiliated companies (located  
in the U.S. and other countries), representative designees of Sponsor that provide 
services related to the device and/or this study, the U.S. Food and Drug Administration 
and other government authorities (in the U.S. and other countries), and the Institutional 
Review Board (IRB) for the purpose of: 1)  monitoring the research; 2) accurately 
documenting and reporting any adverse events that may occur during your participation 
in this study 3) satisfying any other requirements imposed by government authorities 
located throughout the world, including the U.S. FDA.  No information or records that 
disclose your identity will be published without your consent, nor will any information 
or records that disclose your identity be removed or released without your consent 
unless otherwise permitted by law.  Your regular doctor may be told of your 
participation in the study at your request. 
 
You will be assigned a unique study number as a subject in this study.  This number will 
be used on any research-related information collected about you during the course of 
this study, so that your identity [i.e. your name or any other information that could 
identify you] as a subject in this study will be kept confidential.  Information that 
contains your identity will remain only with the study investigator and/or designate.  
The list that matches your name to the unique study number that is used on your 
research-related information will not be removed or released without your consent 
unless required by law. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site at 
any time. Please note information may not be available on ClinicalTrials.gov until the 
study is completed and the device is marketed.  
 
By signing the Patient Consent Form, you are consenting to the collection, use, review, 
processing and disclosure of such information. 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 148 of 211  
20. What will happen to the results of the study? 
Once the study is complete and analyzed, the results may be submitted for publication 
in a scientific journal and presented at scientific conferences. Your confidentiality will be 
maintained and you will not be identified in any report or publication of this study. If 
you wish to see the results when they are published, let the researcher who obtains 
informed consent from you know and a copy of the results can be sent to you.  
 
The data may be used for additional medical or scientific research projects in the future 
and obtaining regulatory approvals for further studies about the device.  Data may, if 
necessary for the above purposes, be communicated to the processors, regulatory 
authorities and Ethics Committees located in countries of the European Economic Area 
(“EEA”), in the United States of America (“USA”), Canada, and governmental agencies 
(including regulatory agencies) in other countries.  Some of the non-EEA countries to 
which your data may be transferred may not offer an adequate level of protection of 
privacy of personal data. St Jude Medical has taken security measures to ensure your 
personal data will be processed and used in a confidential way. Data may also be used 
to present reimbursement information to public and private payers to advocate changes 
in coverage, coding or reimbursement rates and payment policies.   
 
21. Who is organizing and funding the study? 
This study is being organized and funded by St. Jude Medical. 
 
The < Hospital> will receive payments from St Jude Medical for participating in this 
study and for providing study data.   
 
22. What expenses may result from my participation in the study? 
You or your insurance will be billed for tests that are standard of care and would be 
done even if you were not taking part in the study. Tests and procedures that will be 
done just for the study will be paid for by the sponsor. 
 
You will receive a stipend in the amount of $25 per visit to cover the cost of travel and 
parking for attending required research related visits. There are a total of 8 required 
visits (baseline, 30 day, 6 month, 12 month, 2 year, 3 year, 4 year, and 5 year). 
 
23. Who has reviewed the study? 
The study was reviewed by the < hospital system> and has been approved to be 
conducted at this hospital by the <IRB>.  If you have any questions about your rights as a 
research subject you can contact the <IRB > at <contact information >. 
 
24. What are my responsibilities if I am in the study? 
As study participant, you are asked to follow study requirements, follow medical 
instructions given by your study doctor, inform your study doctor of any changes in your 
health, and inform your study doctor of any other medical care or drugs you are 
receiving (whether prescribed by a physician or bought over the counter). 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 149 of 211  
AUTHORIZATION TO USE AND DISCLOSE HEALTH INFORMATION 
 
I agree to permit {add Investigator name here} and staff members and, St. Jude Medical, 
the sponsor of the PORTICO clinical trial to use and disclose health information that 
identifies me for the purposes described below.  I also agree to permit {add 
hospital/clinical study site information here}, my doctors, and my other health care 
providers to disclose health information in my medical records to the researchers, St. 
Jude Medical and the FDA, or other regulatory bodies for the purposes described below. 
 
1. 
The health information that may be used and disclosed includes: 
• All information collected during the research as described in the Informed 
Consent Form; and 
• Health information in my medical records that is relevant to the research 
described in the Informed Consent Form. 
 
2. 
The researchers may: 
• 
Use and share my health information to conduct the research; 
• 
Disclose my health information to the Sponsor of research, St. Jude Medical 
and its affiliated companies (located in the U.S. and other countries), 
representatives designees that provide services related to the device and/or 
this study; 
• 
Disclose my health information as required by law; 
• 
Disclose my health information to representatives of government 
organizations and other persons who are required to watch over the safety 
and effectiveness of medical products and therapies and the conduct of 
research; and  
• 
Remove from my health information my name and other information that 
could be used to identify me. 
 
3. 
St. Jude Medical and its affiliated companies (located in the U.S. and other 
countries), representatives designees that provide services related to the device 
and/or this study may: 
• Use and share my health information to conduct the research; 
• Disclose my health information as described in the Informed Consent 
• Disclose my health information as required by law;  
• Disclose my health information to representatives of government 
organizations and other persons who are required to watch over the safety 
and effectiveness of medical products and therapies and the conduct of 
research; and  
• Remove from my health information my name and other information that 
could be used to identify me. 
 
4. 
Once information that could be used to identify me has been removed, the 
information that remains is no longer subject to this Authorization and may be 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 150 of 211  
used and disclosed by the researchers and St. Jude Medical and its affiliated 
companies (located in the U.S. and other countries), representatives designees 
that provide services related to the device and/or this study as permitted by law. 
 
5. 
Once my health information has been disclosed to a third party, privacy laws 
may no longer protect it from further disclosure.  However, the researchers and 
St. Jude Medical agree to protect my health information by using and disclosing 
it only as permitted by me in this Authorization and the Informed Consent.  Also, 
no publication about the research will reveal my identity without my specific 
written permission.  These limitations continue even if I revoke (take back) this 
Authorization. 
 
Please note that: 
• You do not have to sign this Authorization, but if you do not, you will not 
be allowed to participate in the research. 
 
• You may change your mind and revoke this authorization at any time. To 
revoke this Authorization, you must write to {name and contact 
information}.  However, if you revoke this Authorization, you will no 
longer be allowed to participate in the research.  Also, if you revoke this 
Authorization, the information already obtained by the researchers and 
St. Jude Medical may be used and disclosed as permitted by the 
Authorization and the Informed Consent. 
 
• While the research is in progress, you will not be allowed to see your 
health information that is created or collected in the course of the 
research.  After the research is finished, however, you may see this 
information as described in the {add hospital/clinical study site name 
here}’s Notice of Information practices.  
 
• This Authorization does not have an expiration (ending) date. 
 
• You will be given a copy of this Authorization after you have signed it. 
 
Thank you for considering taking part in this study. 
 
If you decide to participate you will be asked to sign the below and will be given a 
copy of this form to keep. 
 
Name of Principal Investigator: [Insert Name] 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 151 of 211  
1. 
I confirm that I have read and understood the Informed Consent for this Portico IDE 
study. I have had sufficient time to think about it and I have been given the opportunity 
to ask questions, and have had these answered satisfactorily 
2. 
 I understand that:  
• my participation is voluntary and that I am free to refuse to participate in this study 
or to withdraw at any time, without giving any reason and without my medical care 
or legal rights being affected  
• my relationship with my doctor will not be affected if I withdraw 
• there will not be any penalty if I decide to withdraw from the study 
• if I withdraw before the aortic valve replacement procedure, I will not get a St Jude 
Medical Portico valve 
• my attendance at study visits is important to the study and I should follow the study 
doctors instructions 
3. 
I understand that: 
• my medical information, information collected during the study and study results 
may be looked at, used, and disclosed by responsible individuals from St. Jude 
Medical,  a U.S. company, and its affiliates (located in the U.S. and other countries, 
and other people who work for St. Jude Medical to provide services related to the 
device and this study, regulatory authorities, the IRB and, when it is relevant to my 
taking part in this research. I give permission for these individuals to have access to 
my medical information, information collected during the study, and study results 
• my data gathered in this study may be stored (after anonymized) in a database and 
may be used and disclosed by St Jude Medical  
• my relevant personal data may be used for the purpose of this clinical study 
• data collected from the time I sign this document until the time I withdraw from the 
study will be used after I withdraw 
• I will not financially benefit from this study 
• I may be responsible for insurance copayments 
4. 
I understand how to contact the research team 
 
5. 
I agree to my General Practitioner being informed of my participation in the study 
 
6. 
I understand the risks of aortic valve surgery and the risks of participating in this study and  
 
7. 
I am willing to participate in this study 
 
 
Name of Participant (please print) 
Signature 
Date                 
Time___________                 
 
Name of Person Obtaining Consent (please print) 
Signature 
Date 
Time___________ 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 152 of 211  
Appendix R: List of Investigational Sites in the Study 
This list is subject to change. SJM maintains a current list of the Investigational Sites 
conducting the study that is available upon request. 
 
Principal 
Investigator(s)/Address 
Site Name 
IRB Approval  
IRB Chairperson/Address 
Paul Sorajja, MD 
920 East 28th St. Suite 300 
Minneapolis, MN 55407 
Abbott Northwestern 
Hospital/Minneapolis 
Heart Institute 
X 
Stephen Rosenfeld, M.D., M.B.A. 
Quorum IRB 
1601 Fifth Ave. 
Suite 1000 
Seattle, WA 98101 
Ravi Ramana, DO 
Antone Tatooles, MD 
4440 West 95th Street 
2nd Floor, Physician Office 
Building 
Oak Lawn, IL 60653 
Advocate Christ 
Medical Center 
X 
Stephen Rosenfeld, M.D., M.B.A. 
Quorum IRB 
1601 Fifth Ave. 
Suite 1000 
Seattle, WA 98101 
Lewis W. Britton III, MD 
Albany Medical College 
47 New Scotland Avenue MC 
192 
Albany, NY 12208 
 
Albany Medical Center 
 
X 
Currien MacDonald, MD 
Western Institutional Review Board 
1019 39th Ave SE Suite 120 
Puyallup, WA 98374-2115 
Ramzi Khalil, MD 
320 East North Avenue 
Pittsburgh, Pennsylvania 
15212 
Allegheny Singer 
Research Institute 
X 
Currien MacDonald, MD 
Western IRB 
1019 39th Avenue SE, Suite 120 
Puyallup, WA 98374-2115 
Ashish Pershad, MD 
Banner-University Medical 
Center Phoenix 
Cavanagh Heart Center  
1111 E McDowell Road  
Phoenix AZ 85006 
Banner University 
Medical Center 
(Phoenix) 
X 
Currien MacDonald, MD 
Western IRB 
1019 39th Ave SE, Suite 120 
Puyallup, WA 98374-2115 
H. Edward Garrett, Jr., MD 
6019 Walnut Grove Road 
Memphis TN, 38120 
Baptist Memorial 
Hospital 
 
X 
Currien MacDonald, MD 
Western Institutional Review Board 
1019 39th Ave SE Suite 120 
Puyallup, WA 98374-2115 
Alan Zajarias, MD 
Barnes-Jewish Hospital 
4940 Parkview Place 
St. Louis, MO 63110 
Barnes-Jewish 
Hospital/Washington 
University 
X 
Jonathan Green, MD 
Washington University School of 
Medicine IRB 
660 South Euclid Ave. 
Campus Box 8089 
St. Louis, MO 63110 
Bassem M Chehab, MD 
1100 N. Saint Francis 
Suite 300 
Wichita, KS 67214 
Cardiovascular 
Research Institute of 
Kansas 
X 
Via Christi Hospitals Wichita, INC. 
Institutional Review Board 
929 N. St. Francis  
Wichita, KS 67214 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 153 of 211  
Principal 
Investigator(s)/Address 
Site Name 
IRB Approval  
IRB Chairperson/Address 
James Flynn, MD 
100 McGregor Street 
Manchester, NH, 03102 
Catholic Medical Center 
X 
Eleanor Dahar 
Catholic Medical Center IRB 
100 McGregor Street 
Manchester, NH 03102 
Raj R. Makkar, MD 
Cedars-Sinai Medical Center 
127 S. San Vicente Ave 
#A3600 
Los Angeles, CA 90048 
Cedars-Sinai Medical 
Center 
X 
Stephen Lim 
 Cedars-Sinai 
Office of Research Compliance and 
Quality Improvement 
6500 Wilshire Blvd, Suite 1800 
Los Angeles, CA 90048 
John Riddick, MD 
V. Sreenath Reddy, MD  
2400 Patterson Street Suite 
502, Nashville, TN 37203 
Centennial Medical 
Center 
X 
Currien MacDonald, MD 
Western IRB 
1019 39th Avenue SE, Suite 120 
Puyallup, WA 98374-2115 
Joseph S. Coselli, MD 
Guilherme V. Silva, MD 
Texas Heart Institute 
6770 Bertner Avenue 
Suite 350 
Houston, TX 77030 
CHI St. Luke's Health 
Baylor College of 
Medicine 
Medical Center 
 
X 
Currien MacDonald, MD 
Western Institutional Review Board 
1019 39th Ave SE Suite 120 
Puyallup, WA 98374-2115 
 
Flor Munoz-Rivas, MD 
Baylor College of Medicine Office of 
Research 
One Baylor Plaza, 600D 
Houston, TX 77030 
Amar Krishnaswamy, MD 
Lars Svennson, MD 
The Cleveland Clinic 
Foundation 
9500 Euclid Ave. 
Cleveland, OH 44195 
The Cleveland Clinic 
Foundation 
X 
Alan E. Lichtin, MD 
The Cleveland Clinic Foundation 
9500 Euclid Avenue/Wb2 
Cleveland, OH 44095 
Brijeshwar S Maini, MD 
4205 W. Atlantic Ave, Suite 
201B Delray, FL 33445 
Delray Medical Center 
X 
Currien MacDonald, MD 
Western Institutional Review Board 
1019 39th Ave SE Suite 120 
Puyallup, WA 98374-2115 
Todd Kiefer, MD 
Jeffery Gaca, MD 
Duke University Medical 
Center 
2301 Erwin Road 
Box 3126 
Durham, NC 27710  
Duke University 
Medical Center 
X 
John Fallette, MD 
Duke University School of Medicine 
Institutional Review Board 
2424 Erwin Rd., Suite 405 
Durham, NC 27705 
Andy Kiser, MD 
East Carolina Heart Institute 
115 Heart Drive 
Greenville, NC 27834 
East Carolina Heart 
Institute 
X 
Wiley Nifong, MD 
University & Medical Center (UMC) IRB 
600 Moye Boulevard 
Greenville, NC 27884 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 154 of 211  
Principal 
Investigator(s)/Address 
Site Name 
IRB Approval  
IRB Chairperson/Address 
Robert Guyton MD Emory 
University Hospital Midtown 
550 Peachtree Street 
Atlanta, GA 30308 
Emory University 
X 
Clifford Gunthel 
Emory University Institutional Review 
Board 
1599 Clifton Rd, 5th Floor 
Atlanta, GA 30322 
Gerald Yong, Dr 
Fiona Stanley Hospital 
11 Robin Warren Drive 
Murdoch, WA 
Murdoch, Western Australia 
6150 
Fiona Stanley Hospital 
(Australia) 
X 
Dr Ramin Gharbi 
Research Ethics & Governance Unit 
East Metropolitan Health Service 
Level 3, Colonial House 
Royal Perth Hospital 
Perth WA 6000 
Andrew Taussig, MD 
Florida Hospital for Research 
601 E. Rollins St. MB#99 
Orlando, FL 32803 
Florida Hospital 
Orlando 
X 
Faoud Hajjar, MD 
Florida Hospital Institutional Review 
Board 
212 E Winter Park St 
Orlando, FL 32804 
Carlos E Ruiz, MD, PhD 
Elie Elmann, MD 
Hackensack University 
Medical Center 
30 Prospect Avenue 
5 Main Building, Rm 564 
Hackensack, NJ 07601 
Hackensack University 
Medical Center 
 
X 
Currien MacDonald, MD 
Western Institutional Review Board 
1019 39th Ave SE Suite 120 
Puyallup, WA 98374-2115 
David Brown, MD 
William Brinkman, MD 
4716 Alliance Blvd 
Pavilion Two, Suite 340 
Plano, TX 75093 
The Heart Hospital 
Baylor, Plano 
X 
Lawrence R. Schiller, MD 
Baylor Scott & White Research Institute 
IRB 
3310 Live Oak, Suite 501 
Dallas, TX 75204 
Faraz Kerendi, MD 
Frank Zidar, MD 
Heart Hospital of Austin / 
Cardiothoracic and Vascular 
Surgeons 
1010 West 40th St. 
Austin, TX 78756 
Heart Hospital of Austin 
X 
Matthew Cowperthwaite 
St. David’s HealthCare IRB 
St. David’s Medical Center 
919 East 32nd Street 
Austin, TX 78705 
Anthony Caffarelli, MD  
1 Hoag Drive 
Newport Beach, CA 92663 
Hoag Memorial 
Hospital Presbyterian 
X 
Currien MacDonald, MD 
Western IRB 
1019 39th Avenue SE, Suite 120 
Puyallup, WA 98374-2115 
Nimesh Desai, MD 
Jay Giri, MD 
Hospital of the University of 
Pennsylvania 
3400 Spruce Street 
Cardiology, 9 Founders 
Pavilion 
Philadelphia, PA 19104 
Hospital of the 
University of 
Pennsylvania 
X 
Tracy Ziolek, MS CIP 
University of Pennsylvania Institutional 
Review Board 
3800 Spruce Street 
First Floor Room 151 
Philadelphia, PA 19104 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 155 of 211  
Principal 
Investigator(s)/Address 
Site Name 
IRB Approval  
IRB Chairperson/Address 
Azhil Durairaj, MD 
625 S. Fair Oaks Ave., Suite 
215 
Pasadena, CA 91105 
Huntington Memorial 
Hospital 
 
X 
Stephen Rosenfeld, MD 
Quorum IRB 
1501 Fourth Avenue 
 Suite 800 
 Seattle, WA 98101 
Eric Sarin, MD 
Inova Heart and Vascular 
Institute 
3300 Gallows Road, Suite 
3100 
Falls Church, VA 22042 
Inova Fairfax Hospital 
X 
Currien MacDonald, MD 
Western IRB 
1019 39th Ave SE, Suite 120 
Puyallup, WA 98374-2115 
 
Atul Chawla, MD 
Iowa Heart Center 
411 Laural Street 
Des Moines, IA 50314 
Iowa Heart Center 
X 
Joseph Mitros, MD 
Mercy medical Center IRB 
1111 6th Ave 
Des Moines, IA 50314 
Marcos Nores, MD 
Mark Rothenberg, MD 
5301 South Congress Avenue 
Atlantis, FL 33462 
JFK Medical Center 
X 
Currien MacDonald, MD 
Western Institutional Review Board 
1019 39th Ave SE Suite 120 
Puyallup, WA 98374-2115 
Gary Gershony, MD 
Tanveer Khan, MD 
2540 East Street 
Concord, CA 94520 
John Muir Medical 
Center 
 
X 
Richard Messian, MD 
John Muir Health 
2540 East St. 
Concord, CA 94520 
Chad Kliger, MD 
S Jacob Scheinerman, MD 
Lenox Hill Hospital 
130 East 77th St. 
Black Hall 4th Floor 
New York, NY 10075 
Lenox Hill Hospital 
 
X 
Currien MacDonald, MD 
Western IRB 
1019 39th Ave SE, Suite 120 
Puyallup, WA 98374-2115 
Gregory Fontana, MD 
Vishva Dev, MD 
215 West Janss Road 
Thousand Oaks, CA 91360 
Los Robles Regional 
Medical Center 
 
X 
Currien MacDonald, MD 
Western Institutional Review Board 
1019 39th Avenue SE Suite 120 
Puyallup, WA 98374-2115 
Vaughn Starnes, MD 
USC Healthcare Consultation 
Center II 
1520 San Pablo St. 
Suite 4300 
Los Angeles, CA 90033 
Keck Medicine of USC 
(University of Southern 
California) 
X 
Darcy V Spicer, MD 
Health Sciences IRB 
General Hospital Suite 4700 
1200 North State Street 
Los Angeles, CA 90033 
 
Martin Ng, Professor 
3 Technology Place 
Macquarie University, New 
South Wales 2109 
Macquarie University 
Hospital (Australia) 
X 
Professor Tony Eyers 
Research Hub, Building C5C East 
Macquarie University  
NSW 2109 Australia 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 156 of 211  
Principal 
Investigator(s)/Address 
Site Name 
IRB Approval  
IRB Chairperson/Address 
Robert Frankel, MD 
Gregory Crooke, MD 
4802 10th Avenue 
Brooklyn, NY 11219 
Maimonides Medical 
Center 
X 
William Solomon, MD 
Maimonides Institutional Review Board 
4802 10th Avenue 
Brooklyn, NY 11219 
Roberto Rodriguez, MD 
100 Lancaster Avenue 
Wynwood, PA 19096 
Main Line Health 
Center/Lankenau 
Hospital 
X 
Albert A. Keshgegian, MD, PhD  
Main Line Hospitals  
Institutional Review Board 
Lankenau Institute for Medical Research 
259 N. Radnor Chester Road, Suite 280 
Radnor, PA 19087 
Ignacio Inglessis, MD 
Massachusetts General 
Hospital 
55 Fruit St., GRB 109 
Boston, MA 02114 
Massachusetts General 
Hospital 
X 
Elizabeth Hohmann, MD 
Partners IRB 
116 Huntington Avenue, Suite 1002 
Boston, MA 02116 
Kevin Greason, M.D. 
David R. Holmes, Jr, MD 
Mayo Clinic 
200 First Street SW 
Rochester, MN 55905 
Mayo Clinic (Rochester, 
MN) 
X 
William Tremaine, MD 
Mayo Clinic IRB 
IRB Office Personnel, 201 Building, 
Room 4-60 
200 First Street SW 
Rochester, MN 55905 
Prakash Balan, MD 
Tom C. Nguyen, MD 
Memorial Hermann Hospital 
6410 Fannin Street, Suite 600 
Houston, TX 77030 
Memorial Hermann 
Hospital, Houston 
X 
Morris Blajchman, MD 
Chesapeake IRB  
6940 Columbia Gateway Dr., Suite 110 
Columbia, MD 210466 
Joseph Kozina, MD 
Frank Slachman, MD  
4001 J Street  
Sacramento, CA 95819 
Mercy General Hospital 
X 
Jeffrey Braff, PhD 
Dignity Health Sacramento-Sierra IRB 
3810 J Street 
Sacramento, CA 95816 
Robert Merritt, MD 
Mercy Hospital - Springfield 
1235 E. Cherokee 4th Floor 
Cath Lab Springfield, MO 
65804 
Mercy Hospital 
Springfield 
 
X 
Currien MacDonald, MD 
Western Institutional Review Board 
1019 39th Ave SE Suite 120 
Puyallup, WA 98374-2115 
 
Neal Kleiman, MD 
Michael Reardon, MD 
6565 Fannin St. 
Houston, TX  77030 
The Methodist Hospital 
X 
Susan M. Miller, MD, MPH 
Houston Methodist Hospital 
Office of Research Protection 
MGJ6-014 
1130 John Freeman Blvd 
Houston, TX  77030 
Mark Groh, MD 
William Abernethy, MD 
Ashville Cardiovascular & 
Thoracic Surgeons, P.A. 
Mission Health & 
Hospitals   
X 
Leonard Cruz, MD 
Mission Health IRB 
509 Biltmore Avenue 
Asheville, NC 28801 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 157 of 211  
Principal 
Investigator(s)/Address 
Site Name 
IRB Approval  
IRB Chairperson/Address 
257 McDowell Street 
Ashville, NC 28803 
Joshua Rovin, MD 
Lang Lin, MD 
455 Pinellas St. 
Clearwater, FL 33756 
Morton Plant Valve 
Clinic 
 
X 
Joy Cavagnaro, PhD, DABT, RAC 
 Chesapeake IRB  
6940 Columbia Gateway Dr., Suite 110 
Columbia, MD 21046 
Mark Russo,MD 
Marc Cohen, MD 
201 Lyons Avenue 
2nd Floor Bridge 
Newark, NJ 07112 
Newark Beth Israel 
Medical Center 
X 
Patrick Hinfey, MD 
Newark Beth Israel Medical Center 
201 Lyons Ave 
Newark, NJ 07112 
Arash Salemi, MD 
Shing-Chiu Wong, MD 
520 East 70th Street 
New York, NY  10021 
New York Presbyterian 
Hospital / Cornell 
University 
X 
Alavy Sos, MS  
Weill Cornell Medicine 
Institutional Review Board 
1300 York Avenue Box 89 
New York, NY 10065 
David Talton, MD 
Cardiothoracic Surgery Clinic 
830 S Gloster Street 
Tupelo, MS 38801 
North Mississippi 
Medical Center 
 
X 
Charles King, MD 
North MS Health Services IRB 
830 South Gloster Street 
Tupelo, MS 38801 
Stephen Ramee, MD 
1514 Jefferson Highway  
New Orleans, LA 70121 
Ochsner Medical 
Center 
X 
Joseph L. Breault, MD, ScD, CIP 
Ochsner Health System IRB 
1514 Jefferson Highway 
Brent House 514 
New Orleans, LA 70121 
Scott Lilly, MD 
473 W 12th Avenue, Suite 200 
Columbus, OH 43210 
The Ohio State 
University 
Wexner Medical Center 
 
X 
Currien MacDonald, MD 
Western Institutional Review Board 
1019 39th Ave SE Suite 120 
Puyallup, WA 98374-2115 
Mohammad Ghani, MD 
Robert Bodenhamer, MD 
Oklahoma Heart Hospital 
4050 W. Memorial Rd., 3rd 
Floor 
Oklahoma City, OK 73120 
Oklahoma Heart 
Hospital 
X 
Currien MacDonald, MD 
Western Institutional Review Board 
1019 39th Ave SE Suite 120 
Puyallup, WA 98374-2115 
Mark Kozak, MD 
500 University Drive 
Hershey, PA 17033 
Penn State Milton S. 
Hershey Medical 
Center 
X 
Chairman: Dr. Patricia Gordon 
PSU-Human Subjects Protection Office 
IRB-ASB Room 1140 #A115 
90 Hope Drive  
PO Box 855 
Hershey PA 17033 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 158 of 211  
Principal 
Investigator(s)/Address 
Site Name 
IRB Approval  
IRB Chairperson/Address 
Hemal Gada, MD 
409 South Second Street 
Harrisburg, PA 17105 
Pinnacle Health System 
 
X 
Seth Narins, MD, PhD 
Pinnacle Health Hospitals Institutional 
Review Board  
307 South Front Street 
Press Hall First Floor 
Harrisburg, PA 17104 
Stephen Worthley, MD 
North Terrace 
Adelaide, South Australia  
5000 
Royal Adelaide Hospital 
(Australia) 
X 
A/Prof Andrew Thornton 
Chairman, Royal Adelaide Hospital 
Human Research Ethics Committee 
Level 4, Women’s Health Centre 
Royal Adelaide Hospital 
North Terrace 
Adelaide, South Australia, 5000 
Tomasz Stys, MD 
Sanford USD Medical Center 
1210 W 18th Street 
Sioux Falls, SD 57104 
Sanford USD Medical 
Center 
X 
Currien MacDonald, MD 
Western Institutional Review Board 
1019 39th Ave SE Suite 120 
Puyallup, WA 98374 
Paul Teirstein, MD 
10666 North Torrey Pines Rd 
Room S-1056 
La Jolla, CA 92037 
Scripps Green   
X 
Ronald A. Simon, MD 
Scripps Office for the Protection of 
Research Subjects 
4275 Campus Point Court 
CPB 200 
San Diego, CA 92121 
Paul Mahoney, MD  
600 Gresham Drive Norfolk, 
VA 23507 
Sentara Norfolk 
General Hospital 
X 
Currien MacDonald, MD 
Western IRB  
1019 39th Avenue SE, Suite 120 
Puyallup, WA 98374-2115 
Gaurav Dhar, MD 
Norbert Baumgartner, MD 
1200 E. Michigan Ave., Suite 
550 
Lansing, MI 48912 
Sparrow Clinical 
Research Institute 
 
X 
Currien MacDonald, MD 
Western Institutional Review Board 
1019 39th Ave SE Suite 120 
Puyallup, WA 98374-2115 
Newell B Robinson, MD 
George Petrossian, MD 
St. Francis Hospital 
100 Port Washington Blvd. 
Roslyn, NY 11576-1348 
St. Francis  Hospital  
X 
Mitchell Chorost MD 
St. Francis Institutional Review Board 
100 Port Washington Blvd 
Roslyn, NY 11576-1348 
Adnan Chhatriwalla, MD 
Keith B Allen, MD 
4401 Wornall Road 
Kansas City, MO 64111 
St. Luke’s Hospital of 
Kansas City 
X 
Justin Osborne, MA 
Schulman Associates IRB 
4445 Lake Forest Drive 
Suite 300 
Cincinnati, OH 45242 
David A. Heimansohn, MD 
James B. Hermiller, MD 
St. Vincent Hospital  
St. Vincent Hospital 
X 
P.T. Hodgin, MD 
St. Vincent Institutional Review Board 
8402 Harcourt Road, Suite 120 
Indianapolis, IN 46260 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 159 of 211  
Principal 
Investigator(s)/Address 
Site Name 
IRB Approval  
IRB Chairperson/Address 
10590 North Meridian Street 
Indianapolis, IN 46290 
William F. Fearon, MD 
Michael Fischbein, MD 
300 Pasteur Drive, Falk CVRB, 
ULN MC: 5407 
Stanford, CA 94305 
Stanford University 
Medical Center 
X 
Darrell M. Wilson, MD 
Stanford IRB, Panel on Human Subjects 
in  Medical Research  
1215 Welch Road, Modular A 
Stanford, CA 94305 
David Roberts, MD  
2800 L Street  
Sacramento, CA 95816 
Sutter Medical Center 
Sacramento 
X 
Currien MacDonald, MD 
Western IRB  
1019 39th Avenue SE, Suite 120 
Puyallup, WA 98374-2115 
Ming Zhang, MD 
550 17th Avenue 
CH Prof. Bldg. Suite 303 
Seattle, WA 98122 
 
Swedish Medical 
Center 
 
X 
Currien MacDonald, MD 
Western Institutional Review Board 
1019 39th Ave SE suite 120 
Puyallup, WA 98374-2115 
Tony Walton, Pr. 
Cardiovascular Medicine 
Services (Heart Centre) 
The Alfred 
3rd Floor, WS Philip Block 
Melbourne, Victoria 3004 
The Alfred Hospital 
(Australia) 
X 
A/Prof Andrew Thornton 
Chairman, Royal Adelaide Hospital 
Human Research Ethics Committee 
Level 4, Women’s Health Centre 
Royal Adelaide Hospital 
North Terrace 
Adelaide, South Australia, 5000 
Christopher Raffel, MD 
The Prince Charles Hospital 
Rode Road 
Chermside, Queensland 4032 
The Prince Charles 
Hospital (Australia) 
X 
A/Prof Andrew Thornton 
Chairman, Royal Adelaide Hospital 
Human Research Ethics Committee 
Level 4, Women’s Health Centre 
Royal Adelaide Hospital 
North Terrace 
Adelaide, South Australia, 5000 
Mark Sasse, MD 
1806 6th Avenue South 
Birmingham, AL 35249 
University Hospital - 
Univ. of Alabama at 
Birmingham (UAB) 
 
X 
Currien MacDonald, MD 
Western Institutional Review Board 
1019 39th Ave SE Suite 120 
Puyallup, WA 98374-2115 
John P Vavalle, MD 
160 Dental Circle 
6th Floor, Burnett-Womack 
Bldg 
Chapel Hill, NC 27599 
University of North 
Carolina at Chapel Hill 
 
X 
David Weber, MD, MPH, MPA 
Office of Human Research Ethics 
720 Martin Luther King, Jr. Blvd. 
Bldg. 385, 2nd Floor 
CB#7097 
Chapel Hill, NC 27599-7097 
Thomas Gleason, MD 
Joon Sup Lee, MD 
UPMC 
200 Lothrop St Suite C700 
Pittsburgh, PA 15213 
University of Pittsburgh 
Medical Center 
X 
Currien MacDonald, MD 
Western IRB 
1019 39th Ave SE, Suite 120 
Puyallup, WA 98374-2115 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 160 of 211  
Principal 
Investigator(s)/Address 
Site Name 
IRB Approval  
IRB Chairperson/Address 
Anwar Tandar, MD 
50 North Medical Drive 
Salt Lake City, UT 84132 
University of Utah 
Hospital 
 
X 
Gerald Treiman 
University of Utah Institutional Review 
Board 
Research Administration Bldg 
75 South 2000 East 
Salt Lake City, UT 84112 
Ron Waksman, MD  
Paul Corso, MD 
Washington Hospital Center 
110 Irving Street NW 
Suite 4B3 
Washington, DC 20010 
Washington Hospital 
Center 
X 
Joy Cavagnaro, PhD, DABT, RAC 
Chesapeake Research Review, Inc. 
(CCRI) 
7063 Columbia Gateway Dr., Suite 110 
Columbia, MD 21046 
Richard Schwartz, D.O. 
259 First St 
Mineola, NY 11501 
 
Winthrop-University 
Hospital 
 
X 
Harry Staszewski, MD 
Institutional Review Board 
Winthrop-University Hospital 
222 Station Plaza North, Suite 521 
Mineola, NY 11501 
 
 
 
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 161 of 211  
Appendix S: TAVR Leaflet Motion Sub-study  
 
Background 
Worldwide Portico implants, including new enrollments for the Portico OUS clinical 
trials, were paused in September 2014 so that a detailed investigation could be 
conducted to gain better insight into a leaflet motion observation present on 4D-CT 
scanning during the Portico US IDE study.  
As a part of the US IDE study, CT scans were being performed at 30-days post-implant 
for all patients to evaluate clinical stent deformations for stent stress/strain level 
determination as required by FDA. 4D-CT videos were generated from the original CT 
images at the discretion of the investigator at a clinical investigational site. While 
reviewing the 4D-CT video of 2 patients, the physicians noticed a leaflet motion 
observation. Since 4D-CT videos have not been previously validated or routinely used to 
visualize leaflet motion, it was not clear whether the leaflet motion observation was 
real. SJM determined it in the best interest of patients to pause all Portico implants 
(worldwide) until such time this observation and its clinical impact was better 
understood. 
Through investigation of additional 4D-CT scan image data in combination with Trans-
Esophageal Echocardiography (TEE) in the available US study population, more mobility 
observations were noted in Portico as well as commercially available valves. Bench 
testing, manufacturing reviews, core lab investigation and clinical assessments were 
conducted throughout this investigation and significant analysis took place.  
Manufacturing related factors were ruled out as the root cause factors of leaflet motion 
observations. 
The leaflet motion observation was determined to be caused by the presence of a layer 
of subclinical valve thrombus. Analysis concluded that valve thrombosis in the recess 
between the stent frame and the aortic surface of the leaflet was causing the observed 
leaflet motion observation. For patients identified with a leaflet motion observation, 
valve hemodynamic assessment was found to be within normal limits and patients were 
generally asymptomatic. 
An assessment of hemodynamic data across all patients was conducted, focused on 
valve hemodynamic data that was collected at the time of hospital discharge and at the 
30-day follow-up visit. There was no statistically significant difference in the mean aortic 
valve (AV) gradient or in the mean aortic valve area (AVA), between patients that did 
not have a valve leaflet observation (Group 1) and patients that did (Group 2), across all 
patients implanted with any device type. 
There was no statistically significant difference in the mean AV gradient at hospital 
discharge and at 30-day follow up visit between Group 1 and Group 2. The AVA for 
patients implanted with the Portico valve did have a small, statistically significant 
difference at hospital discharge between Group 1 and Group 2, with no significant 
difference at the 30-day follow up visit. 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 162 of 211  
Purpose 
The purpose of this sub-study is to further assess valve leaflet motion in subjects 
implanted with the Portico Transcatheter Aortic Valve as well as FDA-approved 
commercially available valves participating in the Portico US IDE Trial. 
 
Objectives 
The objectives for this sub-study are to: 
• Evaluate the incidence of the leaflet motion observation 
• Evaluate the impact of the leaflet motion observation on clinical outcomes and 
valve hemodynamics 
• Evaluate potential contributing factors for developing a leaflet motion 
observation 
 
Design 
This sub-study is a multi-center, prospective, blinded observational study.   
The first approximately 500 subjects enrolled in the Portico US IDE Trial under Clinical 
Investigational Plan at the time of randomization or assignment to a registry (Roll-in or 
Valve-in-Valve) will participate in this sub-study. 
An assessment of leaflet motion will be made by an independent core laboratory based 
on an MSCT scan (or TEE, if MSCT is medically or technically contraindicated) obtained at 
the 30-day follow-up visit, at which time subjects will be assigned into the following 
three groups: 
• Group 1: Patients with normal leaflet motion 
• Group 2: Patients with a leaflet motion observation 
• Group 3: Patients with unknown leaflet status (imaging missing or 
uninterpretable) 
 
For Groups 1 and 2, subjects and investigators will be blinded to the core laboratory 
assessment of leaflet motion.  These subjects will undergo follow-up MSCT (or TEE, if 
MSCT is medically or technically contraindicated) at the 6-month follow-up visit. 
Subjects in Group 3 will be exited from the sub-study, and will not undergo the 6-month 
MSCT (or TEE). 
 
Sample Size 
 
New enrollment in the sub-study will end when approximately 285 randomized subjects 
have been enrolled.  Allowing for 30% attrition/missed scans/inadequate scan quality, a 
total of 200 complete sets of 30-day and 6-month scans (MSCT or TEE) will be obtained 
from randomized subjects. The attrition rate will be monitored and the sample-size may 
be extended if needed to achieve 200 complete sets of 30-day and 6-month scans.  The 
sponsor will notify sites when the enrollment target has been met. 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 163 of 211  
Statistical Method and Analysis 
 
The TAVR Leaflet Motion Sub-study is a prospective, multi-center, observational clinical 
study. All patients who have provided written Patient Informed Consent and have been 
randomized or assigned to a registry (Roll-in or Valve-in-Valve) will be considered 
enrolled in the sub-study until the minimum sub-study sample size has been achieved.  
This section describes the statistical methods and analysis for randomized subjects 
unless otherwise specified. Data collected for subjects in a registry (Roll-in or Valve-in-
Valve) will be summarized separately from randomized subjects using descriptive 
statistics. 
     
1. General Considerations 
Descriptive statistics of continuous variables will be presented by leaflet motion groups 
and include sample size, mean, median, standard deviation, minimum and maximum. 
For categorical variables, the number and percentage of subjects in each category will 
be presented by leaflet motion groups. All statistical analyses will be performed using 
SAS for Windows (version 9.3 or higher) or other widely accepted statistical or graphical 
software. 
 
2. Statistical Analysis and Reporting 
a. Analysis of baseline characteristics 
All clinically relevant baseline variables collected in this study will be tabulated and 
compared between the two leaflet motion groups. Categorical variables will be tested 
using Chi-square test or Fisher’s exact tests as appropriate and continuous variables will 
be tested using two sample t-test or Wilcoxon rank-sum test as appropriate. 
   
b. Analysis of incidence of the leaflet motion observation 
The data collected from this sub-study will be used to evaluate the incidence of the 
leaflet motion observation. The incidence of the leaflet motion observation at 30-days 
post-implant will be calculated overall and by each valve brand.  The incidence rate will 
also be calculated at 6-months post-implant. 
 
c. Analysis of clinical outcomes and valve hemodynamics 
Event rates of the following clinical outcomes at 6-months (180 days) will be calculated 
for both leaflet motion groups: 
• Stroke 
• Acute myocardial infarction 
• Heart failure hospitalization 
• Reoperation for structural valve deterioration 
• All-cause mortality 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 164 of 211  
The numerator for 6-month event rate in a leaflet motion group is the number of 
subjects who experienced an event by 180 days. The denominator is the number of 
subjects in that leaflet motion group, however, subjects withdrawn (e.g., due to death, 
subject preference or loss-to-follow-up etc.) before 6 months without an event will be 
excluded.  Fisher’s exact tests will be performed to compare the 6-month event rates 
between the two leaflet motion groups. 
 
The following valve hemodynamic characteristics will be analyzed at 30-days and 6-
months post implant with available hemodynamics data: 
• Aortic valve (AV) mean gradient 
• Aortic valve area  
• Aortic valve regurgitation 
 
Two sample t-tests or Wilcoxon rank-sum tests will be performed to compare AV mean 
gradient and AV area at 1-month visit, 6-month visit, and changes from 1-month to 6-
month visit between the two leaflet motion groups.  Chi-square test or Fisher’s exact 
test will be performed to compare AV regurgitation between the two leaflet motion 
groups. 
Supplementary analyses of clinical outcomes and valve hemodynamics using propensity 
score methods may be performed as necessary to confirm similarity of the two leaflet 
motion groups. Propensity score method will use logistic regression on selected baseline 
variables to determine subject’s propensity of being in one leaflet motion group versus 
another, and then the estimated propensity scores will be used to check balance 
between the leaflet motion groups.  Clinical outcomes and valve hemodynamics will be 
compared adjusting for the propensity scores. When supplementary analyses of 
propensity score adjusted analyses are deemed necessary, the propensity score 
methodology and list of baseline variables will be pre-specified and communicated with 
FDA before the supplementary analyses are performed. 
 
d. Analysis of contributing factors of leaflet motion observation 
The following potential contributing factors of leaflet motion observation at 30 days will 
be analyzed: 
• Antithrombotic therapy 
• Baseline index of flow state (e.g., Stroke volume) 
• Stent depth 
 
Categorical contributing factors will be tested using Chi-square test or Fisher’s exact 
tests as appropriate and continuous contributing factors will be tested using two sample 
t-test or Wilcoxon rank-sum test as appropriate between the two leaflet motion groups. 
In addition, a logistic regression model will be performed for the outcome of leaflet 
motion observation at 30 days including the covariates of all aforementioned 
contributing factors. 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 165 of 211  
Leaflet motion observation incidence rates and descriptive statistics of available clinical 
outcomes and valve hemodynamics will be reported to FDA after 50, 100, 150, and 200 
interpretable 30-day MSCT (or TEE) scans from randomized subjects have been analyzed 
by the Core Lab.   
When 200 complete sets of 30-day and 6-month MSCT (or TEE) scans have been 
analyzed by the Core Lab, all statistical analyses described in this section – Statistical 
Analysis and Reporting will be conducted and a final clinical report will be submitted to 
FDA. 
Within each report, the data obtained from the Registry subjects (Roll-in and Valve-in-
Valve) will be analyzed separately and summarized using descriptive statistics.  
 
 
MSCT Scan Parameters/Site Requirements 
 
The CT Core Laboratory’s Standard Operating Procedures provides detailed data 
acquisition instructions. 
A dual-source CT scanner or a latest generation CT scanner capable of fast gantry 
rotation is required. 
MSCT scans are to be acquired using the following requirements: 
•        The CT scan shall cover the entire heart and aorta to the top of the aortic arch 
including the brachiocephalic artery takeoff.  
•        Intravenous contrast at a dose of 60-100 cc is required for this assessment, at the 
discretion of the treating center. 
•       Full retrospective gating without dose attenuation is required to facilitate an 
acquisition throughout the cardiac cycle. A DICOM with cine 0-100% at 5-10% 
increments should be provided. 
 
TEE Scan Parameters 
 
The Echocardiography Core Laboratory Acquisition Protocol provides detailed 
instructions to standardize transesophageal echocardiogram (TEE) image acquisition. 
 
A physician or sonographer familiar with valvular heart disease and experienced in 
performing echocardiograms should perform each study.  Prior to enrolling the first 
patient, the echocardiographer(s) must take part in the training material supplied for 
this study to insure they are familiar with the clinical protocol and the echo imaging 
protocol. 
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 166 of 211  
Appendix T: Principal Contacts 
 
Portico Executive 
Committee 
 
Interventional 
Cardiologists 
Raj Makkar, M.D. 
Cedars-Sinai Medical Center 
Los Angeles, CA 
David Brown, M.D. 
Heart Hospital Baylor 
Plano, TX 
Samir Kapadia, M.D. 
Cleveland Clinic 
Cleveland, OH 
Carlos Ruiz, M.D. 
Hackensack University Medical Center 
Hackensack, NJ 
Stephen Worthley, M.D. Genesis Care 
Adelaide, Australia 
Cardiovascular 
Surgeons 
Greg Fontana, M.D. 
Los Robles Hospital and Medical Center 
Thousand Oaks, CA 
Nimesh Desai, M.D.  
Hospitals of the University of Pennsylvania 
Philadelphia, PA 
William Brinkman, M.D. 
 
Heart Hospital Baylor 
Plano, TX 
Vinod Thourani, M.D. 
Washington Hospital Center, Washington, 
D.C 
Alfredo Trento, M.D.  
Cedars-Sinai Medical Center 
Los Angeles, CA 
Neurologist Jeffrey Saver, M.D. 
 
University of California 
Los Angeles, CA 
Sponsor St. Jude Medical (now 
Abbott) 
Plymouth, MN 
 
 
 
Data Safety 
Monitoring Board  
Deepak Bhatt, M.D. 
(Chair) 
VA Boston Healthcare System 
Harvard Clinical Research Institute 
Boston, MA 
Patrick Lyden, M.D. 
Los Angeles, CA 
Mitchell Krucoff, M.D. 
Durham, NC 
Donald Glower, M.D. 
Duke University Medical Center Durham, 
NC 
Robert Harrington, M.D. Stanford University 
Stanford, CA 
Bradley Carlin, Ph.D. 
University of Minnesota 
Minneapolis, MN 
 
 
 
Clinical Events 
Committee  
 
Rajendra H. Mehta, MD, 
MS (Co-Chair) 
Duke University Medical Center  
Durham, NC 
Schuyler Jones, MD (Co-
Chair) 
Duke University Medical Center  
Durham, NC  
Robert Harrison, MD 
Duke University Medical Center  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 167 of 211  
Durham, NC 
Bradly Kolls, M.D. 
 
Duke University Medical Center 
Durham, NC 
Joseph Dedrick Jordan, 
M.D., PhD 
University of North Carolina 
Chapel Hill, NC 
Shu Lin, MD 
Duke University Medical Center 
Durham, NC 
 
Robert Mentz, MD 
Duke University Medical Center 
Durham, NC 
 
Renato Lopes, MD 
Duke University Medical Center 
Durham, NC 
 
Keith Dombrowski, MD 
Duke University Medical Center 
Durham, NC 
 
Matthew Roe, MD 
Duke University Medical Center 
Durham, NC 
 
Chiara Melloni, MD 
Duke University Medical Center 
Durham, NC 
 
David Kong, MD 
Duke University Medical Center 
Durham, NC 
 
Thomas Povsic, MD 
Duke University Medical Center 
Durham, NC 
 
Sreekanth Vemulapalli, 
MD 
Duke University Medical Center 
Durham, NC 
 
Karen Alexander, MD 
Duke University Medical Center 
Durham, NC 
 
Matthew Brennan, MD 
Duke Clinical Research Institute 
Durham, NC 
 
 
 
Echocardiography 
Core Laboratory 
Neil J. Weissman, M.D. 
(Director) 
Medstar Health Research Institute 
6525 Belcrest Road, Suite 700 
Hyattsville, MD 20782 
Electrocardiography 
Core Laboratory 
Thomas Todaro, M.D.  
(Director) 
Medpace, Inc. 
5375 Medpace Way 
Cincinnati, OH  45227 
CT Sizing Core 
Laboratory 
Rahul Sharma, M.D.  
(Director) 
Cedars-Sinai Heart Institute 
8700 Beverly Blvd 
West Hollywood, CA 90048-1804 
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 168 of 211  
Appendix U: NIH Stroke Scale (NIHSS) 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 169 of 211  
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 170 of 211  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 171 of 211  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 172 of 211  
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 173 of 211  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 174 of 211  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 175 of 211  
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 176 of 211  
Appendix V: Portico Continued Access Protocol (CAP) Synopsis 
 
1. Purpose 
 
1.1 Indications for Use 
The Portico™ Transcatheter Heart Valve is indicated for patients with symptomatic 
severe native aortic stenosis, who are considered high or extreme surgical risk. 
 
1.2 Study Design and Objectives 
The PORTICO IDE CAP is a prospective, multicenter, single-arm, continued access study 
designed to collect additional safety and clinical effectiveness data on the SJM Portico 
Transcatheter Heart Valve and Delivery System (Portico) following completion of 
enrollment in both the pivotal IDE randomized cohort and FlexNav Study. The study will 
also allow implanters to maintain their technical proficiency while the pre-market 
approval (PMA) application for the Portico™ Transcatheter Aortic Heart Valve and the 
FlexNav™ Delivery System is under FDA review.    
The Pivotal IDE trial completed enrollment of 758 randomized subjects in October 2017. 
Enrollment in the FlexNav study is anticipated to be completed in May 2019 and upon 
reaching this milestone, the CAP will be (re)initiated. IDE sites were first approved to 
enroll subjects in the CAP using the first-generation Portico Delivery System in October 
2017 under protocol version K. However, the latest protocol revision (version L) requires 
enrollment of subjects in the FlexNav study to be complete before enrollment the CAP 
using the second-generation FlexNav™ Delivery System can resume.   
Up to 1260 subjects may participate in the CAP. This sample size is based on the 
assumption of one enrollment per IDE center per month for 21 months, assuming 60 IDE 
centers in the US and Australia actively participate in the CAP study. This expected 
enrollment rate is based on the enrollment rate in the pivotal IDE trial over the last 12 
months. The 21-month duration of the CAP is based on the 12-month follow-up 
requirement for the randomized cohort and a 9-month PMA review. Subjects enrolled in 
the CAP will be followed for a minimum of one year and up to 5 years or upon study 
completion (whichever is reached first). Interim safety and efficacy data on CAP subjects 
will be reported annually to the FDA as a part of the Portico IDE annual report until 
study closure.  
 
1.3 Study Endpoints 
The primary and secondary endpoints for this clinical study have been modified from 
that in the pivotal IDE trial to account for the design and objectives of the CAP.  The 
primary endpoint in the CAP will focus on the early safety of the Portico valve using a 
composite endpoint of all-cause mortality or disabling stroke at 30 days post-
implantation.  
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 177 of 211  
A selection of descriptive endpoints including valve performance parameters, clinical 
function assessments and adverse events defined according to VARC II1 criteria will be 
assessed at 30 days (and at 1 year if indicated)   
 
Primary Endpoints 
Primary Safety Endpoint: A composite of VARC 2 defined all-cause mortality or disabling 
stroke at 30 days. 
 
Descriptive Endpoints 
A selection of key valve performance parameters, clinical function assessments and 
adverse events defined according to VARC 2 criteria will be assessed: 
• Technical device success defined as successful vascular access, delivery and 
deployment of the Portico Valve; retrieval with the delivery system and correct 
positioning of a single valve in the proper anatomical location 
• Life threatening bleeding requiring blood transfusion and major bleeding at 30 
days from the index procedure 
• Acute kidney injury at 30 days from the index procedure 
• Major and minor vascular access complication rate at 30 days 
• Permanent pacemaker insertion at 30 days from the index procedure  
• Paravalvular Leak (PVL) at 30 days and one year 
• NYHA functional classification at 30 days and one year 
• Disabling stroke at 30 day and one year 
• All-cause mortality at 30 day and one year 
• KCCQ Quality of Life (QOL) score from baseline to 30 days and one year 
 
2. Clinical Protocol 
2.1 Background Information 
The purpose of the CAP is to continue collection of safety and effectiveness data on the 
Portico Transcatheter Heart Valve and evaluate the learning curve while the device 
remains under investigational use in the United States.  The CAP will also allow current 
IDE study implanters to maintain their technical proficiency in Portico device 
implantation. The CAP will commence once enrollment in the randomized cohort and 
FlexNav study of the pivotal IDE trial is completed. Subject selection and data collection 
will be similar to the pivotal IDE in order to facilitate future comparison of data with the 
pivotal IDE randomized cohort.  All subjects enrolled in the CAP will undergo Portico 
valve implantation.. Roll-in patients at sites participating in the CAP will be included in 
the IDE roll-in registry.  
                                                     
 
1 Kappetein AP, Head SJ, Genereux P, et al.  Updated Standardized Endpoint Definitions for Transcatheter 
Aortic Valve Implantation: The Valve Academic Research Consortium-2 Consensus Document. J Am Coll 
Cardiol 2012;60:1438-1454. 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 178 of 211  
All CAP subjects enrolled under version L of the protocol will be implanted using the 
second-generation FlexNav™ Delivery System (“FlexNav™ Delivery System”).  
There is no pre-specified minimum number of subjects required to be enrolled in the 
CAP. Enrollment will continue in the CAP until approval of the Portico™ Transcatheter 
Aortic Heart Valve and FlexNav™ Delivery System in the US.  
 
2.2 Rationale 
The rationale for this study is to allow current IDE study implanters to maintain their 
technical proficiency in Portico valve implantation. CAP data will not be included in the 
randomized population nor the primary data analysis; however, the data will be 
analyzed and presented separately and may be used to support the PMA application for 
the Portico™ Transcatheter Aortic Heart Valve and FlexNav Delivery System™.  
 
3. Name and Description of the Investigational Device 
The investigational devices used in the CAP are listed above in Section 2.4 of the main 
protocol above.  
Detailed information regarding the Portico Transcatheter Heart Valve can be found in 
Section 3.0.  
Detailed information regarding the first-generation Portico Delivery System and 
FlexNav™ Delivery System can be found in Sections 3.1.1 and 3.1.2.  
 
4. Risk and Benefits of the Study Device and Clinical Study 
There are no changes to the risks or benefits reported in the pivotal IDE trial for subjects 
participating in the CAP. Please refer to the IFU of the Portico Transcatheter Aortic Heart 
Valve for a description of risks and to the adverse events section in this protocol for a 
list of the potential adverse events. 
 
5. Study Population – High Risk and Extreme Risk 
The study population in the CAP is expected to be the same as that enrolled in the 
pivotal IDE trial ; patients with symptomatic, severe aortic stenosis that are considered 
to be high or extreme risk for surgery and are eligible for TAVI via a transfermoral or 
alternative access route . Although there is no stratification of patients based on risk in 
the CAP, the patients risk classification (high vs extreme) will be documented and 
reviewed for final approval by the Subject Selection Committee.  See Section 5 of the 
main document.  
 
6. Inclusion/Exclusion Criteria 
The inclusion/exclusion criteria for the CAP are the same as that in the pivotal IDE trial. 
See Sections 5.1 and 5.2 of the main protocol.  
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 179 of 211  
7. Screening Process 
The screening process for the CAP is the same as the pivotal IDE trial. Although there is 
no randomization in the CAP, after Subject Selection Committee approval, patients 
assigned to the CAP will not be considered enrolled until the index procedure. Subjects 
who do not meet the subject selection criteria will not be scheduled for Portico valve 
implantation and will be exited from the study without further follow-up 
 
8. Subject Assignments 
Subjects in the CAP are not randomized. All subjects will undergo a Portico valve implant 
attempt. 
9. Subject Enrollment 
CAP subjects will be considered enrolled into the study after completion of all of the 
following steps:  
1. Signed informed consent is obtained. 
2. Based on the screening assessments, it is determined that the subject meets all 
of the inclusion and none of the exclusion criteria. 
3. Subject is approved by the subject selection committee. 
4. The trial cohort has been determined, and understood by the subject. 
5. The Portico delivery system enters the subjects’ body.  
Subjects who are scheduled to receive a Portico valve via transfemoral access and found 
not to be suitable for this delivery modality (per the heart team medical decision) can 
receive a Portico valve using an alternate access modality and vice versa. However, this 
will be considered a protocol deviation unless the Subject Selection Committee provides 
prior pre-approval for multiple access sites. The rationale for this decision must be 
documented.  
 
10. Study Conduct 
Table 9 summarizes the required assessments in the pivotal IDE and CAP.  The primary 
differences between the required pivotal IDE assessments and the CAP assessments are: 
• A 6 month visit is not required 
• The 6MWT and SF-36 will not be required at any follow-up visit 
 
 
 
 
11. Statistical Methods and Analysis 
11.1 Analysis Population (CAP) 
The CAP analysis population will include all subjects enrolled in the CAP in whom a 
Portico valve implant is attempted.   A Portico implant attempt is defined as the 
insertion of the delivery system into the subject’s body.   

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 180 of 211  
 
11.2 Statistical Analysis 
The primary study endpoint at 30 days will be summarized and descriptively compared 
to results reported in the pivotal IDE randomized cohort and published results on CAV 
All descriptive endpoints will be summarized and presented for the entire analysis 
population and according to access route (transfemoral vs alternative access) .  
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 181 of 211  
Appendix W: Portico IDE FlexNav Study Synopsis 
 
1. PURPOSE 
1.1 Indications for Use 
The Portico™ valve is indicated for transcatheter delivery in patients with symptomatic 
severe native aortic stenosis who are considered high or extreme surgical risk.  
The FlexNav™ delivery system is indicated for transcatheter delivery of the Portico™ 
valve. The delivery system is indicated for insertion into the vessel with or without an 
arterial introducer sheath.  
The FlexNav™ loading system is indicated for loading the Portico™ valve in the FlexNav™ 
delivery system. 
 
1.2 Study Design and Objectives 
The primary objective of the PORTICO pivotal IDE FlexNav study (“FlexNav study”) is to 
characterize the safety of the second-generation FlexNav™ Delivery System (“FlexNav™ 
Delivery System). 
The FlexNav study will be conducted as a prospective, multicenter, investigational study 
arm of the PORTICO pivotal IDE trial.  Up to 200 patients (includes a maximum of 100 
roll-ins) with symptomatic, severe aortic stenosis considered by a local Heart Team to be 
high or extreme risk for surgical aortic valve implantation will be enrolled from up to 70 
US and Australian IDE sites. Upon provision of informed consent, subjects will undergo 
Portico valve implantation via a transfemoral or alternative access approach. Subject 
selection and key data collection will follow the pivotal IDE protocol to facilitate direct 
comparison of safety outcomes with the randomized cohort. 
Abbott plans to submit safety results when 100 analysis subjects (excludes roll-ins) have 
reached 30 days of follow-up in the PMA application. To achieve the minimum study 
sample of 100 analysis subjects, data may be pooled with subjects (maximum 50 
subjects) enrolled in a prospective, multicenter single-arm FlexNav EU CE Mark study. 
The concurrent CE Mark study will follow the same subject selection and data 
collection/follow-up protocol as the FlexNav study to facilitate pooling of data. Subjects 
in the FlexNav study will continue to be followed according to the pivotal IDE protocol 
with scheduled follow-up at 6 months and annually thereafter to 5 years. 
   
1.3 Study Endpoints 
1.3.1 Primary Endpoint 
The primary safety endpoint of the FlexNav study is VARC II defined major vascular 
complications at 30 days.   
The endpoint for this study has been modified from the composite primary safety 
endpoint in pivotal IDE trial to be able to assess the potential advantage of key system 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 182 of 211  
modifications to the FlexNav™ Delivery System on the safety outcome measure likely to 
be directly impacted, i.e., access site and access-related major vascular complications.   
 
1.3.2 Descriptive Endpoints 
A selection of endpoints from the pivotal IDE trial including valve performance 
parameters, clinical function assessments and adverse events defined according to VARC 
II1 criteria will be assessed at 30 days and included in the PMA application: 
 
Descriptive Endpoints:  
1. Non-hierarchical composite of all-cause mortality, disabling stroke, life 
threatening bleeding requiring blood transfusion, acute kidney injury requiring 
dialysis, or major vascular complications at 30 days from the index procedure 
2. All-cause mortality at 30 days from the index procedure 
3. Disabling stroke at 30 days from the index procedure 
4. Non-disabling stroke at 30 days from the index procedure 
5. Life threatening bleeding requiring blood transfusion at 30 days from the index 
procedure 
6. Major bleeding at 30 days from the index procedure 
7. Acute kidney injury at 30 days from the index procedure 
8. Minor vascular complication rates at 30 days from the index procedure 
9. Permanent pacemaker insertion at 30 days from the index procedure  
10. Paravalvular Leak (PVL) at 30 days from the index procedure 
11. NYHA functional classification at 30 days from the index procedure 
12. KCCQ Quality of Life (QOL) score from baseline to 30 days from the index 
procedure 
13. Technical device success defined as successful vascular access, delivery and 
deployment of the Portico Valve; retrieval with the delivery system and correct 
positioning of a single valve in the proper anatomical location 
 
Additional endpoints to be assessed at one year but not included in the PMA 
application: 
1. Composite of all-cause mortality or disabling stroke at one year from the index 
procedure  
2. All-cause mortality at one year from the index procedure 
3. Disabling stroke at one year from the index procedure 
4. Non-disabling stroke at one year from the index procedure 
5. Paravalvular Leak (PVL) at one year from the index procedure 
6. KCCQ Quality of Life (QOL) score from baseline and one year from the index 
procedure 
7. NYHA functional classification at one year from the index procedure 
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 183 of 211  
2. CLINICAL PROTOCOL 
2.1 Background Information 
In 2017, the AHA/ACC revised their guidelines in a focused update to make TAVR a class 
I indication (previously a class IIa indication) for the treatment of aortic valve stenosis in 
patients at prohibitive or high-surgical risk.2  As the use of TAVR expands into younger, 
lower risk populations, minimizing vascular complications which are amongst the most 
frequent and serious complications of TAVR is of paramount importance as studies show 
vascular and bleeding complications during the procedure are associated with increased 
morbidity and mortality risk.3,4    
Edwards LifeSciences and Medtronic are the current TAVR market leaders accounting 
for 95% of the global TAVI market share. Two key design elements of the commercially-
available balloon-expandable Edwards Sapian 3 valve and self-expanding Medtronic 
CoreValve Evolut R/Pro valve systems that help mitigate the frequency of vascular and 
bleeding complications are: 1) a low insertion profile due to the use of a custom 
expandable sheath (Sapien 3) and integrated sheath (Evolut R/Pro); and 2) the ability to 
achieve precise valve placement without repositioning or with minimal need to re-
sheath and reposition.  
The safety and effectiveness of the Abbott (legacy St. Jude Medical) family of CE Marked 
Portico™ Transcatheter Aortic Heart Valves (size range 23-29mm) is currently being 
assessed in the PORTICO pivotal US IDE trial. A total of 70 sites in US and Australia are 
participating in the prospective, multi-center, randomized (1:1), controlled clinical study 
with enrollment of 758 randomized high or extreme-risk patients completed in October 
2017. Following completion of one-year follow-up on all randomized patients, 30-day 
safety and 1-year effectiveness data will be submitted as part of a PMA application to 
the FDA to support commercial use of the Portico™ System in the US. 
The first-generation Portico Delivery System used in the PORTICO pivotal IDE trial has 
recently undergone several design modifications to compete against the market-leading 
TAVR devices and allow future movement into expanded patient indications. The 
second-generation FlexNav™ Delivery System (“FlexNav™ Delivery System”) leverages 
much of the existing Portico platform and technology (ie. maintains the deliverability of 
the first-generation Portico Delivery System) while incorporating design features that 
improve overall performance and provide one of the lowest insertion profiles. 
Specifically, the FlexNav™ Delivery System features a redesigned handle for easier use 
during deployment, a hydrophilic stability layer to minimize system manipulations and 
support precise valve placement and an integrated sheath to reduce the delivery profile 
diameter to minimize vessel trauma at the access site.  
While these new design modifications do not alter the procedure to load or deploy the 
Portico valve, the safety profile of the FlexNav™ Delivery System is expected to be 
comparatively better to the first-generation Portico Delivery System. Abbott (legacy 
SJM) is therefore proposing to undertake a prospective, single-arm study (“FlexNav 
study”) to collect safety outcomes data on the FlexNav™ Delivery System, which will be 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 184 of 211  
submitted as part of the PMA application to support commercial use of the Portico 
Transcatheter Heart Valve with the FlexNav™ Delivery System in the US.  
The proposed FlexNav study will be conducted as separate arm of the pivotal IDE trial 
and will include a minimum of 100 analysis patients. To achieve a study cohort of 100 
analysis patients, data may be combined with patients participating in a prospective, 
multicenter single-arm FlexNav EU CE Mark study. SJM (now Abbott) plans to submit 
safety results when a total of 100 subjects from this study and the FlexNav EU CE Mark 
study have reached 30 days of follow-up in the PMA application. 
Characterizing the safety profile of the FlexNav™ Delivery system with respect to rate of 
major vascular complications, which is expected to be directly impacted by the recent 
design modifications to the delivery system, is the primary focus of the clinical 
investigation.  
 
2.2 Rationale 
The rationale for conducting the FlexNav study within the PORTICO pivotal IDE trial is to 
enable the direct comparison of 30-day safety outcomes data for the FlexNav™ Delivery 
System to the first-generation Portico Delivery System.  Results from the FlexNav study 
will be included in a PMA application to support US approval of the Portico 
Transcatheter Heart Valve and FlexNav™ Delivery System. 
Up to 200 high or extreme risk patients (includes a maximum of 100 roll-ins) with 
symptomatic, severe native aortic stenosis who meet eligibility criteria for the pivotal 
IDE trial via a transfemoral or alternative access approach will be enrolled in the study to 
ensure sufficient precision to assess the clinical impact of the FlexNav™ Delivery System 
on rate of major vascular complications at 30 days. The FlexNav study will require 
physicians to enroll a minimum of one (1) and up to (3) roll-in subjects to provide 
implanters with some initial experience using the FlexNav™ Delivery System (maximum 
100 roll-ins).  Data from 100 analysis subjects (excluding roll-ins) will be used to assess 
the safety of the FlexNav™ Delivery System. 
It is expected the rate of major vascular complications at 30 days will be numerically 
lower to the rate reported in the randomized cohort (Portico arm) of the pivotal IDE trial 
using the first-generation Portico Delivery System due to design modifications that (1) 
enhance valve deliverability, (2) reduce the system’s profile and (3) minimize vessel 
trauma at the vascular-access site. 
 
3. NAME AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE 
The investigational devices used in the FlexNav Study are listed in Section 2.4 of the 
main protocol above.  
Detailed information regarding the Portico™ Transcatheter Aortic Heart Valve can be 
found in Section 3.0 of the main protocol.  
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 185 of 211  
Detailed information regarding the FlexNav™ Delivery System can be found in Section 
3.1.2 of the main protocol. There is no change in the intended use of the FlexNav™ 
Delivery System compared to the first-generation Portico Delivery System.  
Key design modifications that have been made to the FlexNav™ Delivery System are 
intended to reduce the profile of the catheter, improve deliverability, enhance 
deployment accuracy and promote overall ease of use.  
Key design features of the FlexNav™ Delivery System include:  
• Addition of an integrated sheath 
• Addition of a stability layer 
• Minor changes to the nosecone, inner/outer shafts, retainer 
• Addition of a hydrophilic coating  
• Minor changes to the handle 
These design modifications do not alter the procedure to load or deploy the Portico 
valve. The FlexNav™ Delivery System is designed for transfemoral, subclavian/axillary 
and transaortic use. 
 
3.3 Instructions for Use 
For instructions for use (IFU) of the Portico™ Transcatheter Aortic Heart Valve and 
FlexNav™ Delivery System please refer to the IFU (Number 600014467) which includes 
the following: 
• Portico™ Transcatheter Aortic Valve (PRT-23-IDE, PRT-25-IDE, PRT-27-IDE, PRT-
29-IDE) 
• FlexNavTM Delivery System (FN-DS-SM-IDE, FN-DS-LG-IDE)  
• FlexNavTM Loading System (FN-LS-SM-IDE, FN-LS-LG-IDE) 
 
3.4 FlexNav™ Delivery System Training 
Training on the FlexNav™ Delivery System will be conducted with all implanting 
physicians prior to their first roll-in case. Training will be performed in-person and will 
require physicians to complete both a didactic and simulated- training component. The 
didactic component will include a detailed overview of the new delivery system 
features, associated procedural steps for using the FlexNav™ Delivery System via a 
transfemoral access route (and if applicable to the site, alternative access route) and 
review of optimal Portico valve implant techniques. The simulated-training component 
will require physicians to deploy the Portico valve with the new delivery system via a 
transfemoral approach and a subclavian or transaortic approach (if the implanter 
intends to perform alternative access cases) using a bench top model. A minimum of 
two successful deployments with the bench top model using either the 18F or 19F 
delivery system in a specific access route will be required. 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 186 of 211  
Training records will be controlled documents managed by the Sponsor. If updates are 
made to the training plan, physicians will be required to complete the revised training 
prior to their next case.  
Training will be valid for 60 calendar days only. If a physician does not implant a Portico 
value using the FlexNav™ Delivery System within 60 calendar days of initial training they 
will be required to undergo a review of the FlexNav™ Delivery System and implant 
procedure with an Abbott Field Clinical Procedural Specialist prior to use (roll-in or 
analysis cohort). Benchtop deployments optional.  
 
4. RISK AND BENEFITS OF THE STUDY DEVICE AND CLINICAL STUDY 
There are no changes to the risk or benefits reported in the pivotal IDE trial for subjects 
participating in the FlexNav Study. Please refer to the Portico™ Transcatheter Aortic 
Heart Valve and FlexNav Delivery System IFU for a description of risk to benefits and a 
list of the potential adverse events. 
 
5. STUDY POPULATION 
5.1 Study Cohort 
The FlexNav study is limited to subjects with symptomatic, severe aortic stenosis who 
are determined to be at high or extreme operative risk for surgical aortic valve 
replacement. The operative risk determination will be based on the Society of Thoracic 
Surgeons (STS) Adult Cardiac Surgery Risk Calculator. A surgeon's assessment of 
operative comorbidities, including medical and anatomic factors not captured by the STS 
risk calculator will also be considered in determining a subject’s operative risk.  
To maintain a comparable risk profile to the pivotal IDE randomized cohort that 
completed enrollment in October 2017, the analysis population of 100 subjects in the 
FlexNav study will be limited to 20 extreme risk subjects (no more than 20% of total 
analysis cohort). 
 
5.2 Inclusion/Exclusion Criteria 
The inclusion/exclusion criteria for the FlexNav Study is the same as the pivotal IDE trial. 
Refer to Sections 5.1 and 5.2 of the main protocol for details.  
Additional exclusion criteria for subjects being considered for Portico valve implantation 
via an alternative access approach using the FlexNav™ Delivery System include: 
For transaortic access using the FlexNav™ Delivery System: 
1. Subject has a distance between the annular plane and the aortic access site 
<7 cm (2.8") 
2. Subject has a distance between the annular plane and the separate 
introducer sheath distal tip <6 cm (2.4") 
For subclavian/axillary access using the FlexNav™ Delivery System: 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 187 of 211  
1. Subject’s access vessel (subclavian/axillary) has a distance between the 
annular plane and the integrated sheath distal tip <17 cm (6.7") 
2. Subject’s access vessel requires the delivery system to be advanced through 
a separate introduce sheath 
 
5.3 Screening Process 
Subject case reviews will be conducted to determine a patient’s eligibility to receive a 
Portico valve (roll-in and analysis population) by the same independent Subject 
Selection Committee used in the pivotal IDE trial.  
The risk definitions will be the same as the pivotal IDE trial to ensure a consistent 
patient population is enrolled. The Subject Selection Committee will provide final 
determination of a subject’s risk classification and primary access approach. If a site 
disagrees with the Subject Selection Committee’s final decision regarding risk 
classification and/or primary access approach the subject will not be eligible for 
enrollment in the study. 
 
6. SUBJECT ASSIGNMENTS 
Subjects in the FlexNav study are not randomized. All subjects will undergo a Portico 
valve implant attempt.  
Subject assignments (roll-in or analysis population) will be assigned by the Sponsor after 
Subject Selection Committee approval and prior to enrollment, based on the primary 
implanting physician’s recent Portico experience.  
 
6.1 Subject Enrollment 
Subjects will be considered enrolled into the FlexNav study after completion of all of the 
following steps:  
1. Signed informed consent is obtained. 
2. Based on the screening assessments, it is determined that the subject meets all 
of the inclusion and none of the exclusion criteria. 
3. Subject is approved by the Subject Selection Committee. 
4. Subject assignment (roll-in or analysis) has been determined by the Sponsor. 
5. The Portico delivery system enters the subjects’ body.  
Subjects who are approved by the Subject Selection Committee to receive a Portico 
valve via transfemoral access and are found during the procedure not to be suitable for 
this delivery modality (per the heart team medical decision) may receive a Portico valve 
using an alternate access modality and vice versa. This will be considered a protocol 
deviation unless the Subject Selection Committee pre-approved the subject for multiple 
access sites. The rationale for this decision must be documented by the site.  
As in the pivotal IDE trial, to ensure enrollment balance across study sites, no 
investigational site will enroll more than 20% of the analysis population.  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 188 of 211  
 
 
6.2 Roll-in Cohort 
A minimum of one (1) and up to three (3) roll-in subjects will be required per primary 
implanting physician at each site. Data from roll-in subjects will be added to the IDE Roll-
in Registry and will not be included in the analysis population of 100 subjects. A 
maximum of 100 roll-in subjects will be permitted in the study.  
The total number of roll-in subjects required per site will be at the discretion of the 
Sponsor and will be based on the primary implanting physician’s recent Portico implant 
experience.  
Investigational sites that do not comply with the IFU during the roll-in phase will not be 
permitted to enroll analysis subjects in the FlexNav study. 
 
6.3 Proctoring  
A Portico proctor will be required to attend a minimum of one (1) roll-in case at 
investigational sites that have not performed a Portico valve implant in the last 12-
months. Sites that have enrolled subjects as part of the CAP (under version K of the 
protocol) may require a Portico proctor at the request of the Sponsor. The request by 
the Sponsor will be dependent on the site’s enrollment cadence and safety performance 
in the CAP.  
 
7. STUDY CONDUCT 
Assessments required at screening, baseline, pre- and post-procedure, prior to hospital 
discharge and during follow-up in the FlexNav study will be the same as that in the 
pivotal IDE trial. Stroke ascertainment and evaluation will be performed according to 
VARC II recommendations and the pivotal IDE protocol. Detailed information can be 
found in Section 7.0 of the main protocol.  
Subjects enrolled in the FlexNav study will be followed for a minimum of one year and 
annually thereafter for up to 5 years.  
 
7.1 Core Laboratories 
The same independent core laboratories and processes used in the pivotal IDE trial will 
be utilized for evaluating CT images, ECG rhythms and echocardiograms for the FlexNav 
study.   
 
7.2 Subject Selection Committee 
The independent Subject Selection Committee will be responsible for final approval of a 
study subjects’: 
1. risk classification (high vs extreme) based on patients’ clinical history, STS score, 
non-STS comorbidities (including frailty indices) and key patient demographics.  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 189 of 211  
2. primary access route based on independent core-laboratory CT imaging. A 
secondary access route may also be approved.  
As in the pivotal IDE trial, the Subject Selection Committee will provide guidance with 
respect to Portico valve size selection based on CT-measured annular dimensions (area, 
perimeter, diameter, eccentricity) and calcification. However, the investigational site has 
the final decision for which Portico valve size is selected for implantation. 
 
8. DATA COLLECTION AND MANAGEMENT 
The schedule for data collection and management of data will follow the pivotal IDE 
trial. Refer to Section 8.0 of the main protocol for details.   
Enrolled subjects who undergo a Portico implant attempt but do not receive a Portico 
valve will be assessed for any adverse events through to 30 days post-procedure, and 
will then be terminated from the study.  
If a subject is consented and undergoes study-specific testing (i.e., testing that would 
not be done if they were not being considered for the study) but is not enrolled in the 
study (FlexNav™ Delivery System does not enter the subject’s body), the subject will be 
exited from the study without any further follow-up.  
 
9. INDEPENDENT BOARDS  
9.1 Clinical Events Committee  
All adverse events will be adjudicated by the same independent Clinical Events 
Committee used in the pivotal IDE trial according to the Valve Academic Research 
Consortium (VARC II) definitions1. The independent Clinical Events Committee will have 
final adjudication responsibilities for subject outcomes related to the primary safety 
endpoint at 30 days and descriptive endpoints at 30 days and one-year follow-up.  
The independent Clinical Events Committee will be responsible for adjudicating the 
following adverse events at 30 days: 
• mortality (all-cause and cardiovascular related) 
• stroke (non-disabling and disabling)  
• life-threatening bleeding requiring blood transfusion 
• major bleeding 
• acute kidney injury requiring dialysis 
• major vascular complications (access-site related and access related) 
• minor vascular complications 
• permanent pacemaker insertion 
The independent Clinical Events Committee will be responsible for adjudicating the 
following adverse events at one year: 
• mortality (all-cause and cardiovascular related) 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 190 of 211  
• stroke (non-disabling and disabling)  
 
 
9.2 Data and Safety Monitoring Board  
The same independent Data and Safety Monitoring Board used in the pivotal IDE trial 
will be engaged to review the progress and safety of subjects enrolled in the FlexNav 
study. 
 
10. STATISTICAL METHODS AND ANALYSIS 
10.1 Analysis Population  
The analysis population will include the first 100 enrolled subjects, excluding roll-ins, in 
whom a Portico implant is attempted with the FlexNav™ Delivery System.   A Portico 
implant attempt is defined as insertion of the FlexNav™ Delivery System into the 
subject’s body.  Subjects who undergo a Portico implant attempt but do not receive a 
Portico valve (i.e. implant procedure is abandoned or subject receives a commercially- 
available valve) will be included in the 30-day analysis population.  
To achieve an analysis population of 100 subjects, data from up to 50 subjects enrolled 
in a prospective, multi-center single-arm FlexNav EU CE Mark study may be combined 
with FlexNav study subjects.  
 
10.2 Sample Size Calculation  
The selected minimum sample size of 100 subjects is based on the desire to estimate 
the rate of major vascular complications at 30-days with a sufficient degree of precision 
so that the 95% upper confidence limit will be within the range of rates reported in 
other Portico studies and for commercially-available transcatheter valves. Additionally, 
it is expected that the rate of major vascular complications at 30 days in subjects 
implanted using the FlexNav™ Delivery System will be numerically lower than the rate 
observed in the pivotal IDE randomized cohort that used the first-generation Portico 
Delivery System.  As reported in the Portico CE Mark study (NCT01493284) and Portico I 
Post-Market Clinical Follow-Up study (NCT01802788), the rate of major vascular 
complications at 30 days for subjects undergoing transfemoral Portico valve 
implantation using the first-generation Delivery System was 7.2% and 5.5% 
respectively5,6. In the CoreValve Evolut R US pivotal study (NCT02207569), access-site 
related major vascular complications at 30 days was reported to be 7.5%7 (includes 
transfemoral and alternative access). 
Assuming an event rate of 7% at 30 days with the FlexNav™ Delivery System, a sample 
size of 100 subjects will produce a two-sided 95% confidence interval with a width equal 
to 11% (i.e. upper confidence limit of 13.9%). The expected upper confidence limit of 
13.9% falls within the reported range for major vascular complications at 30 days (5% to 
23.3%) in a weighted meta-analysis of 3519 patients from 16 TAVI studies8. Therefore, a 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 191 of 211  
minimum of 100 subjects will be required to undergo a Portico implant attempt with the 
FlexNav™ Delivery System via a transfemoral or alternative access approach.  
 
 
10.3 Primary Endpoint 
Acceptable safety of the FlexNav™ Delivery System will be determined from a 
predefined precision estimate for VARC II-defined major vascular complications at 30 
days. Results will be summarized and descriptively compared in context of results for 
the first-generation Delivery System in the randomized cohort (Portico arm) of the 
pivotal IDE trial. 
A comparison to published results for the Portico valve and latest-generation 
commercially- available transcatheter valves will also be provided.  
 
10.4 Descriptive Endpoints 
Descriptive endpoints will be summarized and presented for the analysis population 
(n=100 subjects) and according to access route (transfemoral vs alternative access). 
Additionally, all descriptive endpoints at 30 days will be summarized and descriptively 
compared to rates reported in the randomized cohort of the pivotal IDE trial as well as 
published results for Portico and latest-generation commercially available valves. 
The proportion of subjects who experience each event through 30 days will be 
calculated. The numerator for the 30-day rate in each group will be equal to the number 
of subjects who experience an event by 30 days.  The denominator will be the number 
of subjects in that group excluding subjects that have withdrawn (e.g. due to subject 
preference or lost to follow-up) before 30 days without an event. The proportion of 
technical device success will be summarized. The 95% confidence interval will be 
estimated using exact binomial method. Fisher’s exact tests will be performed to 
compare event rates at 30 days or technical device success rate between groups of 
patients. 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 192 of 211  
11.0 Bibliography 
1. Kappetein AP, Head SJ, Genereux P, et al. Updated Standardized Endpoint 
Definitions for Transcatheter Aortic Valve Implantation: The Valve Academic 
Research Consortium-2 Consensus Document. J Am Coll Cardiol 2012;60:1438-1454. 
2. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, Fleisher LA, Jneid H, 
Mack MJ, McLeod CJ, O’Gara PT, Rigolin VH, Sundt TM and Thompson A. 2017 
AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of 
Patients With Valvular Heart Disease. A Report of the American College of 
Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. 
2017;70:252-289. 
3. Leon, MB. “Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients 
Who Cannot Undergo Surgery”. New England Journal of Medicine. 2010;363:1597-
1607. 
4. Généreux P, Webb JG, Svensson LG, Kodali SK, Satler LF, Fearon WF, Davidson CJ, 
Eisenhauer AC, Makkar RR, Bergman GW, Babaliaros V, Bavaria JE, Velazquez OC, 
Williams MR, Hueter I, Xu K and Leon MB. Vascular Complications After 
Transcatheter Aortic Valve Replacement: Insights From the PARTNER (Placement of 
AoRTic TraNscathetER Valve) Trial. J Am Coll Cardiol. 2012;60:1043-1052. 
5. Möllmann H, Linke A, Holzhey D et al. Implantation and 30-Day Follow-Up on All 4 
Valve Sizes Within the PorticoTranscatheter Aortic Bioprosthetic Family J Am Coll 
Cardiol Intv 2017;10:1538–47. 
6. Maisano F. Late-Breaking Session: Real-world Experience Using the Portico™ 
Transcatheter Aortic Valve: 30-day outcomes in 973 patients enrolled in the Portico I 
Study (Cohort A). May 22, 2018. EuroPCR Paris, France. 
7. Popma J, Reardon M, Khabbaz K et al. Early clinical outcomes after transcatheter 
aortic valve replacement using a novel self-expanding bioprosthesis in patients with 
severe aortic stenosis who are suboptimal for surgery; Results of the Evolut R U.S. 
Study. J Am Coll Cardiol Intv 2017; 10:268-75 
8. Genereux P, Head S, Van Mieghem N, et al. Clinical Outcomes After Transcatheter 
Aortic Valve Replacement Using Valve Academic Research Consortium Definitions: A 
Weighted Meta-Analysis of 3,519 Patients from 16 Studies. J Am Coll Cardiol 
2012;59:2317-2326 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 193 of 211  
Appendix X: Patient Informed Consent (Continued Access Protocol) 
STUDY TITLE:  PORTICOTM RE-SHEATHABLE TRANSCATHETER AORTIC VALVE SYSTEM  
US IDE TRIAL (PORTICO) – CONTINUED ACCESS PROTOCOL 
  
Principal Investigator: <    >  
Hospital: <    >  
 
 
Address: <    > 
 
Phone: <    > 
Sponsor: 
 St. Jude Medical, Cardiology Division Inc. (hereinafter referred to as 
“Sponsor” or “St Jude Medical”) 
 
 
 
 
PART 1 
 
1. Invitation 
You are being invited to take part in a research study.  Before you decide, it is important 
for you to know why the research is being done and what it will involve.  Please take 
time to read the following information carefully.  Feel free to discuss it with others if you 
wish.  Ask us if there is anything that is not clear or if you want more information. Take 
your time to decide if you wish to participate. 
 
2. Purpose of the study 
The purpose of this study is to evaluate the safety and effectiveness of the new St Jude 
Medical Portico Transcatheter Heart Valve and delivery systems.  The study valve is 
made to replace your diseased aortic heart valve.  
 
3. Why have I been invited? 
You are being asked to take part in this research study because your doctors have 
decided that you may be a high or extreme risk candidate for aortic heart valve 
replacement through open heart surgery. At your request, your study doctor will notify 
your personal physician of your participation in this study. 
 
4. How many people will participate? 
This study will be conducted at up to seventy (70) centers globally, and will include a 
maximum of 1260 subjects. 
 
5. What is the device being tested? 
The Portico Transcatheter Heart Valve is an investigational device.  This means that the 
valve is being studied, and is not for sale in the United States. This study is collecting 
data on the valve and delivery systems for review and approval by the Food and Drug 
Administration (FDA).  
 
The Portico Transcatheter Heart Valve is a replacement heart valve that can be placed 
through a tube in your leg or through your chest. The valve is made of animal tissue and 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 194 of 211  
is on a stent, or scaffold, which holds the valve in position. The stent portion of the valve 
is made with Nitinol (metal with Nickel and Titanium).  Picture 1 below shows the 
Portico valve.  Picture 2 on page 6 shows the different ways the valve can be put in 
place. 
 
Picture 1: Portico Aortic Heart Valve 
 
 
 
 
This is for general educational purposes only and is not completely 
representative of what will be implanted 
 
 
 
 
The Portico Transcatheter Heart Valve is loaded into a delivery system which is part of 
the catheter used to help the study doctor place the valve in your heart.  The delivery 
system is about as big around as your ring finger.  The valve is put into the delivery 
system with a two-part funnel system which compresses the stent to fit inside the 
delivery system. 
 
While using echocardiography and fluoroscopy (angiogram pictures) the study doctor 
will position the valve in your heart.  After positioning the heart valve, the delivery 
system will slowly let the valve expand to the full size.   
 
The Portico Transcatheter Heart Valve is designed to have the capability to be released 
slowly in a controlled manner, be repositioned (should the need arise), be removed 
completely and another attempt made, and the final position can be checked 
thoroughly before final valve release (with normal new valve function during the 
assessment). 
 
6. Do I have to take part? 
No. Your participation in this study is entirely voluntary and you are under no pressure to 
take part. If you decide to participate in this study, but later change your mind, you can 
withdraw at any time without explanation and without any loss of medical care or benefits 
you would otherwise have received.  You can withdraw from this study without penalty, 
and withdrawal from this study will not jeopardize your future care or your relationship 
with the study doctor. If you withdraw from the study, you will be asked what the reason 
is for withdrawing from the study, but you do not have to answer.   
 
If the study doctor has concerns about your participation, you will not be able to take 
part in the study.  The study doctor can also withdraw you from the study at any time.   
  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 195 of 211  
If you do decide to take part, you will be asked to sign this consent form. By consenting 
to take part in this study you are agreeing that the Portico valve (Picture 1) may be 
implanted using the delivery system.  
 
7.  What are the alternate treatments? 
If you do not wish to take part in this study, your study doctor may treat your aortic 
valve with: 
1. Medication 
2. An FDA approved Transcatheter Aortic Valve Replacement (TAVR) valve and 
delivery system  
3. Standard open heart surgery by a referral to a heart surgeon  
 
8. How long will my participation last in this clinical study? 
Your participation in this study will begin when you sign the informed consent form and 
for up to five years following your implant, unless it is determined that you do not meet 
the study eligibility criteria or you decide to stop your participation in the study.   
 
If you are enrolled in the study and do not receive a TAVR valve, you will be followed for 
any adverse events through the 30 days post procedure and then withdrawn from the 
study. If you undergo study-specific testing, but are not enrolled, you will be exited from 
the study without any further follow-up.  
 
You may stop your participation in this study at any time.  Your participation in this study 
may also be stopped by the sponsor by your study doctor.  
 
Reasons for ending your participation in the study by the Principal Investigator include, 
but are not limited to, the following: 
• Study participation was not in your best interest  
• You  did not meet the inclusion/exclusion criteria  
• You  and/or family request, if applicable 
• You aren’t able to comply  with the requirement of the study (e.g., you aren’t able to 
attend follow-up visits) 
• Death   
• Your non-compliance with study requirements 
• You are considered “lost to follow-up”, which occurs after a minimum of 3 
documented phone calls of a physician or designee at the study site to the subject or 
emergency contact and a letter sent to the last known address by traceable mail  
• Your participation is terminated by the Principal Investigator if it is not in your best 
interest to continue in the study 
• Study discontinued due to sponsor management decision or request from applicable 
governing bodies 
• Investigational site ends participation in the study 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 196 of 211  
The study may be temporarily stopped or terminated, either at the local or national level, 
at the request of the Institutional Review Board (IRB), regulatory authorities (FDA), or the 
sponsor.   
The sponsor may stop the study if new information about the device is learned during the 
duration of the study to ensure patient safety.  
You will be notified in writing if there are new findings or reasons for any changes to the 
study plan which will affect your continued participation in the study.  
 
9. What will take place during the study? 
 
This is a non-randomized research study. This means you will be implanted with a 
Portico Transcatheter Heart Valve.  
 
 
Before your operation: 
To determine if you qualify for the study, you may have the following tests performed, 
depending on your clinical condition.  None of these tests are considered experimental 
and would be part of your normal care even if you were not in the study: 
 
• Physical Exam: your study doctor or a trained member of his or her staff will ask 
you about your medical history and do a basic physical exam 
• CT Scan: a test to assess the blood vessels (ascending aorta, bilateral iliac arteries) 
of your body  
• Chest x-ray: An x-ray will be taken to assess any abnormalities in your chest.  This 
takes about 5 minutes to complete. 
• Echocardiography (echo): a test that uses sound waves to look at how your heart is 
functioning  
• Electrocardiogram (ECG):  a tracing of your hearts rhythm 
• Lab work: standard blood tests 
• Frailty Index:  an evaluation by your doctor used to predict your risk for medical 
procedures 
• NYHA Functional Classification and Angina Scale:  an evaluation by your study 
doctor to rank the limitations in your daily activities based on shortness of breath 
and chest pain 
• STS Risk Score/EuroSCORE II:  evaluations to measure the amount of risk surgery 
may pose to you 
• Pulmonary Function Test: a breathing test to check the function of your lungs 
• Coronary and Aortic Angiogram: a test to assess the blood vessels of your body 
 
If you do not meet all the criteria for the study, no further procedures will be 
performed. If you do meet all criteria for the study, and would like to participate, then 
you will complete the following tests prior to being scheduled for the procedure.  You 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 197 of 211  
may not have to repeat some tests that were performed during screening. You can 
change your mind even after signing this form; simply let the research staff know. The 
baseline tests include: 
 
• Lab work: standard blood tests 
• Quality of Life Questionnaires (QOL): you will be asked to complete questionnaires 
about your general health, and symptoms that you may or may not have 
• Medications: you will be asked the names of medications you are taking 
• Stroke Scales: scales used to measure the degree of disability or dependence in 
daily activities for people who have had a stroke.  This will be done for this study 
even if you have not had a stroke 
• Disability Scale: an evaluation to assess your physical functions, self-care and ability 
to get around 
• Mini-Mental State Exam: you will be asked to answer questions and to perform a 
few tasks to assess your thinking and memory 
 
During your procedure: 
The Portico Transcatheter Heart Valve implant will be done in the hospital 
catheterization laboratory, a special room for these kinds of procedures.  You may be 
given medication to make you sleepy and more comfortable during the procedure or 
you may be put fully asleep for the duration of the procedure.   
 
 
If your blood vessels are the right size and shape the study doctor will make an incision 
in your groin (upper part of your leg where it connects to your hip) and insert a catheter 
(small tube) into the opening made.  The catheter will be moved through your femoral 
(leg) artery (picture 2a) up to the heart and into position in the heart to allow placement 
of the valve. 
 
If your leg blood vessels are too small or diseased the study valve will be implanted 
through your chest (picture 2b), or through blood vessels near your shoulder (picture 2c 
or 2d) 
   

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 198 of 211  
Picture 2: Different Methods for Valve Implantation 
a
 
b 
 
 
c 
d 
 
 
a) transfemoral b) transaortic c) left subclavian d) left axillary (courtesy of Rodés-Cabau, J. Nat. Rev. 
Cardiol. 9, 15–29 (2012) 
 
The study doctor will use various special imaging methods such as angiographic pictures 
(x-ray picture of the coronary arteries) to check the position of the catheter and valve.  
Once the catheter and valve are in the correct position the study doctor will slide the 
valve out of the catheter and it will unpack and expand to form a replacement aortic 
valve.   
 
With the replacement valve in place, the study doctor will use echo and angiographic 
pictures to check that valve is working correctly.  When the study doctor has confirmed 
placement, the catheter will be removed and you will be taken to the recovery area.  
Following the procedure, if you had the valve placed through your leg, you will have 
pressure applied to the groin area and will be required to lay flat for a specified amount 
of time. If you had the valve placed through your chest, your doctor will determine your 
limitations.  
 
If the study doctor was unable to place the valve in your heart, you may need open 
heart surgery to replace the valve using standard surgical methods.   
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 199 of 211  
During the procedure, a representative from the sponsor may be in the procedure room 
to provide technical support on the device for your doctor.   
 
After your operation 
After your operation, you will be visited by the study doctor. The study doctor will be 
looking to see whether you have any complications from the procedure. Before you are 
discharged from the hospital the following will be done: 
 
• Physical Exam: your study doctor or a trained member of his/her staff will ask 
you about your medical history and do a basic physical exam 
• Echocardiography: a test that uses sound waves to look at how your heart is 
functioning. This test will be completed after the procedure or before you are 
discharged from the hospital. 
• Lab work: standard blood tests 
• Medications: you will be asked for the name of the medications you are taking 
• ECG: tracing of your heart rhythm 
• Stroke Scales: scales used to measure the degree of disability or dependence in 
daily activities for people who have had a stroke.  This will be done for this study 
even if you have not had a stroke 
• Assessment of changes in health status: you will be asked if there are any 
changes in your health status since you have had your heart valve replaced. Your 
health status assessment will continue throughout the course of your 
participation in this study. 
• Disability Scale: an evaluation to assess your physical functions, self-care and 
ability to get around 
• Angina Scale:  an evaluation by your study doctor to rank the limitations in your 
daily activities based on shortness of breath and chest pain 
 
Follow-up visits 
After the procedure, you will return to the study doctor’s office for follow-up visits at 30 
days, 12 months (one year) and yearly through five years after the procedure.  
 
At these visits the following will be done: 
• Physical Exam: your study doctor or a trained member of his/her staff will ask 
you about your medical history and do a basic physical exam 
• ECG:  tracing of your heart rhythm 
• Echocardiography: a test that uses sound waves to look at how your heart is 
functioning.   
• QOL: you will be asked to complete questionnaires about how you are feeling  
• Medications: you will be asked the names of medications you are taking 
• Lab Work: standard blood tests (This will not be done at the yearly visits past one 
year.) 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 200 of 211  
• Assessment of changes in health status: you will be asked if there are any 
changes in your health status since you have had your heart valve replaced. Your 
health status assessment will continue throughout the course of your 
participation in this study. 
• Frailty Index:  an evaluation by your doctor used to predict your risk for medical 
procedures (This will not be done at the yearly visits past one year.) 
• Stroke Scales: scales used to measure the degree of disability or dependence in 
daily activities for people who have had a stroke.  This will be done for this study 
even if you have not had a stroke.  
• NYHA Functional Classification and Angina Scale:  evaluations by your study 
doctor to rank the limitations in your daily activities based on shortness of 
breath and chest pain 
• Mini-Mental State Exam: you will be asked to answer questions and to perform 
a few tasks to assess your thinking and memory (This will not be done at the 
annual visits past one year.) 
• Disability Scale: an evaluation to assess your physical functions, self-care and 
ability to get around  
• Angina Scale: an evaluation by your study doctor to rank the limitations in your 
daily activities based on shortness of breath and chest pain 
 
If you have a suspected stroke or other neurological event, the following will be done at 
a visit 90 days after the event: 
• Neurological assessment:  an examination of how your brain functions to help 
determine if you may have had a stroke 
• Stroke Scales: scales used to measure the degree of disability or dependence in 
daily activities for people who have had a stroke.   
 
10. Health Economic Analysis 
The Sponsor is also conducting a health economic analysis. The Health Economic 
Analysis will evaluate the costs and benefits of treatment. This information is being 
collected so we can understand the cost effects of the treatment in the PORTICO study. 
For the purpose of this Health Economic Analysis, information about your reported 
resource use of hospital care will be collected. Medical resource use, cost and health-
related quality of life within the trial period will be compared between study subject 
groups. 
 
11. Radiation exposure 
This study may involve radiation exposure from a CT or fluoroscopy. As part of everyday 
living, everyone is exposed to a small amount of background radiation. Background 
radiation comes from space and naturally-occurring radioactive minerals.  
 
The angiography procedure uses x-ray radiation to guide the examination.  The amount 
of radiation you are exposed to during this procedure will depend on the complexity of 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 201 of 211  
the procedure, but will range from the equivalent of 3 to 12 years of exposure to the 
natural background radiation to which we are all exposed.  In this research you will not 
be exposed to any additional radiation during the procedure, as you will undergo the 
same procedure regardless of whether or not you choose to participate in this research 
trial.  
 
The overall risk from this dose is considered small. A part of this radiation exposure 
would already be necessary for your medical care. 
 
12. Potential risks and side effects of transcatheter aortic valve implantation 
 
Possible risks and discomforts associated with the participation in this study will be 
similar as those associated with any routine transcatheter aortic valve implantation and 
related follow-up and may include, but are not limited to: 
 
Technical Name 
What it means 
Access site complications 
primarily relates to bruising or bleeding at the 
site where the delivery system was inserted 
Acute coronary obstruction 
blocking the arteries carrying blood to the 
heart 
Acute myocardial infarction 
heart attack 
Access site injury 
Injury during the process of inserting valve or 
the valve damages other parts of the body 
near it 
Allergic reaction to antiplatelet 
agents, contrast medium, 
anesthesia or valve components 
reaction to some medications, x-ray dye, 
procedural dye, or materials used to make the 
valve 
Anaphylactic shock/toxic reaction 
serious allergic reaction 
Annulus rupture 
tearing of the ring tissue around the heart 
valve 
Aortic rupture 
tearing of the aortic valve 
Ascending aortic trauma 
damage to the largest artery in your body. The 
artery is the main supply from the heart.  
Atrio-ventricular node block 
a slowed heart beat due to top and bottom 
chambers of your heart not beating normally 
together  
AV fistula 
abnormal connection between an artery or 
vein 
Bleeding 
an episode which involves bleeding 
Cardiac arrhythmia 
irregular heart beat 
Cardiovascular or vascular injury 
injury to blood vessels, heart  

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 202 of 211  
Technical Name 
What it means 
Conduction system injury 
a change in the way your heart impulses are 
transmitted which may require a pacemaker 
insertion  
Death 
Death 
Endocarditis 
infection in the heart 
Embolism: air, calcification or 
thrombus 
clogging an artery or vein stopping blood flow 
to a body part 
Exercise intolerance (weakness) 
unable to exercise at your normal level of 
physical tolerance 
Fever 
elevated body temperature 
Heart failure 
heart cannot pump enough blood to the rest of 
the body 
Hematoma 
collection of blood outside a blood vessel 
Hemodynamic compromise 
problems with blood flow 
Hemolysis 
break down of the blood cells 
Hemolytic anemia 
abnormal breakdown of the red blood cells in 
your blood 
Hemorrhage 
excessive bleeding  
Hypertension 
blood pressure is too high 
Hypotension 
blood pressure is too low 
Immunological reaction 
disorder of the immune system 
Infection 
organisms in body causing abnormal body 
reactions or sickness 
Leakage, regurgitation 
some blood flows around the edges of the 
valve 
Left ventricular failure/rupture 
 
lower left chamber of your heart does not 
work correctly or tears 
Left ventricular impairment (due to 
apical scar) 
lower left chamber of your heart does not 
work correctly due to past damage  
Myocardial ischemia 
not enough blood flow to the heart muscle 
Mitral valve insufficiency 
heart valve does not close properly and leaks 
Multi-organ failure 
more than one body organ does not function 
Neurological changes including 
stroke/transient ischemic attack 
a blood clot travels to a vessel in your brain 
and blocks blood flow (stroke)/blood flow to a 
part of the brain stops for a brief period of 
time(tia) 
Non-structural dysfunction 
wrong size valve, suture or tissue gets in way 
of valve function 
Pannus 
abnormal layer of tissue 
Paravalvular leak 
some blood flows around the edges of the 
valve 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 203 of 211  
Technical Name 
What it means 
Pericardial effusion 
bleeding into the sac around the heart 
Perforation, of the myocardium or a 
blood vessel                                              
hole in blood vessel 
Potential coronary obstruction 
Coronary artery is blocked 
Renal failure 
kidneys not functioning to normal capacity 
Renal insufficiency 
poor kidney function 
Respiratory failure (shortness of 
breath) 
breathing difficulty requiring medical 
intervention 
Sepsis 
generalized overall systemic infection  
Septal rupture 
tear in the tissue which divides the heart 
chambers 
Stenosis (high gradient) 
a high amount of vessel narrowing  
Stroke 
a blood clot travels to a vessel in your brain 
and blocks blood flow 
Structural valve deterioration 
parts of valve do not work or do not work as 
expected 
Systemic peripheral ischemia 
inadequate blood flow 
Tamponade 
a large amount of fluid collects around the sac 
surrounding your heart  
Valve migration or malposition 
valve movement out of position 
Valve explant 
remove valve  
Valve embolization 
valve is not in contact with aortic annulus 
Valve stenosis 
narrowing of valve opening 
Valve thrombosis 
blood clot is attached to or near the valve 
Ventricular failure (acute) 
lower chamber of your heart is currently not 
functioning 
Ventricular rupture 
tear in the lower chamber of the heart 
Vessel dissection or spasm 
structure of vessel is changed 
 
It is possible these complications could lead to: 
• Transfusion 
• Conversion to open surgical procedure 
• Reoperation 
• Emergent balloon valvuloplasty 
• Emergent percutaneous coronary intervention (PCI) 
• Emergent surgery (i.e., coronary artery bypass, heart valve replacement) 
• Explantation 
• Permanent disability 
• Death 
• Permanent pacemaker 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 204 of 211  
Due to the nature of the delivery methods used, TAVR procedures may be associated 
with an increased risk of stroke and vascular complications when compared to surgical 
aortic valve replacement. 
 
A layer of thrombus (blood clot) has been seen on some TAVR valves when four-
dimensional computed tomography (4D CT) scans or transesophageal echocardiograms 
(TEE) are used to examine the valve after implant. In several cases, this layer of 
thrombus has been shown to prevent valve leaflets from opening properly. The layer of 
thrombus may be present but not seen if a 4D CT scan or TEE is not done. Blood thinners 
and anti-clot medicine can be used to treat the thrombus and may be prescribed by 
your study doctor even if no thrombus has been seen. 
 
The overall risk of death from transcatheter aortic valve implantation at this hospital at 
30 days is between <insert site risk>% (<>/100 to <>/100), depending on your other pre-
existing illnesses. 
 
There are additional risks for study related tests.  These risks may include but are not 
limited to the following: 
 
Blood sample:  the risk of inserting a needle into a vein in your arm may include 
temporary discomfort from the needle stick.  There is also a small risk of infection, 
bruising, swelling, bleeding or fainting.  These risks are minimized by cleansing the site 
carefully prior to obtaining the blood sample and applying pressure to the site after the 
blood sample is obtained. 
 
Echocardiogram:  For a Transthoracic Echocardiogram (TTE), a lubricant (gel) is used on 
the skin to improve picture quality and this may feel cold.  There are no known risks 
associated with receiving a TTE echocardiogram. There may be discomfort from the 
pressure of the transducer as the images are taken. 
 
Another type of echocardiogram is called a Transesophageal Echocardiogram (TEE), 
which takes images by putting a scope down your throat while you are asleep. Some 
risks include, but are not limited to, esophageal bleeding, sore throat, and bruising. 
 
Your doctor will determine which echocardiograms are best to get the best images of 
your heart. 
 
CT/MSCT and Fluoroscopy:  There may be risks due to the radiation used during the CT 
and fluoroscopy scan. There is a risk that the contrast media/dye used during the 
CT/MSCT and fluoroscopy procedures could harm your kidneys or that you will have an 
allergic response.  In either case, your doctor will be prepared to treat you with 
medications.   
 
13. What are the risks for women of childbearing age? 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 205 of 211  
If you are pregnant or plan to become pregnant in the duration of the study, you should 
discuss your participation with your study doctor.  Subjects who become pregnant while 
taking part in the study should contact the study doctor right away.    
 
There could be other risks or discomforts to you (or to an embryo, unborn child or 
nursing infant if you become pregnant) that are not known at this time. You will be told 
in writing about any new information that may become available during your 
participation in the study or that may influence your decision to continue participation 
in this study. 
 
14. Potential Benefits of taking part in the study 
This study may not benefit you directly, but may benefit other patients with a similar 
condition in the future.  Such future benefits to other patients may possibly include: 
• Making the operation simpler by reducing the need for: 
o Open heart surgery  
o Use of the heart and lung machine 
• Fewer number of days spent in the hospital 
• Less risk of complications 
• Allowing a faster return to your normal activity level 
• Potential improvement in your heart function 
 
15. What if something goes wrong? 
Any complaint about the way you have been treated during the study, if you have any 
questions about your rights, or any possible harm you might suffer, talk to your study 
doctor or hospital patient advocate. 
 
16. Whom should I contact if I have questions or if I am injured during the study? 
During the course of this clinical study, if you have any further questions, concerns, or 
research related injuries as a result of your participation, please contact [add Principal 
Investigator contact information here]. 
 
For questions regarding your rights as a research subject, please contact the hospital 
ethics board (often called an IRB or Institutional Review Board) at [add IRB contact 
information here]. 
 
17. What will happen if I don’t want to carry on with the study?  
You can withdraw from the study at any time.  Feel free to inform the study staff of your 
decision to withdraw from the study even while you are being taken to the procedure 
room or are in the procedure room. If you decide not to participate in the study before 
the procedure, you will not get a Portico valve.   
 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 206 of 211  
18. What if there is a problem? 
If you were to suffer harm of any kind as a direct result of this study, treatment for that 
injury including surgery, first aid, and emergency care will be available as applicable 
under Federal, State, and local law.  The hospital or clinic where you received treatment 
will bill your insurance company for the routine costs of care available under your health 
care plan and you may also have to pay some costs such as co-pays or deductibles. 
 
If you followed all study instructions and are hurt during the study as a direct result of 
the study device or study procedures (not part of your routine medical care), the 
sponsor will pay for reasonable and necessary medical and hospital expenses.  
 
The sponsor will not cover the cost of injuries to the extent that they are caused by your 
failure to follow study instructions or other negligence, or that of the hospital or study 
doctor, the natural progression of an underlying condition (whether diagnosed or not) 
or pre-existing condition, or events that would have been expected from the standard 
treatment using currently approved therapies for your condition. 
 
Signing this consent form in no way limits your legal rights against the Sponsor, 
investigators, or anyone else, and you do not release the study doctors or participating 
institutions from their legal and professional responsibilities. If you have a concern 
about any aspect of this study, you should ask to speak to the researchers at < Hospital> 
or <    >, MD who will do his best to answer your questions. 
 
In the event of your death, if you received a Portico valve, your implanted valve may be 
removed and returned to the sponsor for analysis.  The study doctor will get your 
family’s approval prior to removing the device.   
 
19. Will my taking part in this study be kept confidential? 
 If you decided to take part in this research study, your participation, medical records, and 
personal information will be kept confidential to the extent allowed by Federal, State, and 
local law.   However, research records and health or other source records identifying you 
may be inspected by the Sponsor and its affiliated companies (located  in the U.S. and 
other countries), representative designees of Sponsor that provide services related to 
the device and/or this study, the U.S. Food and Drug Administration and other 
government authorities (in the U.S. and other countries), and the Institutional Review 
Board (IRB) for the purpose of: 1)  monitoring the research; 2) accurately documenting 
and reporting any adverse events that may occur during your participation in this study 
3) satisfying any other requirements imposed by government authorities located 
throughout the world, including the U.S. FDA.  No information or records that disclose 
your identity will be published without your consent, nor will any information or records 
that disclose your identity be removed or released without your consent unless 
otherwise permitted by law.  Your regular doctor may be told of your participation in 
the study at your request.   
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 207 of 211  
You will be assigned a unique study number as a subject in this study.  This number will 
be used on any research-related information collected about you during the course of 
this study, so that your identity [i.e. your name or any other information that could 
identify you] as a subject in this study will be kept confidential.  Information that 
contains your identity will remain only with the study investigator and/or designate.  
The list that matches your name to the unique study number that is used on your 
research-related information will not be removed or released without your consent 
unless required by law. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site at 
any time. Please note information may not be available on ClinicalTrials.gov until the 
study is completed and the device is marketed.  
 
By signing the Patient Consent Form, you are consenting to the collection, use, review, 
processing and disclosure of such information. 
 
20. What will happen to the results of the study? 
Once the study is complete and analyzed, the results may be submitted for publication 
in a scientific journal and presented at scientific conferences. Your confidentiality will be 
maintained and you will not be identified in any report or publication of this study. If 
you wish to see the results when they are published, let the researcher who obtains 
informed consent from you know and a copy of the results can be sent to you.  
 
The data may be used for additional medical or scientific research projects in the future 
and obtaining regulatory approvals for further studies about the device.  Data may, if 
necessary for the above purposes, be communicated to the processors, regulatory 
authorities and Ethics Committees located in countries of the European Economic Area 
(“EEA”), in the United States of America (“USA”), Canada, and governmental agencies 
(including regulatory agencies) in other countries.  Some of the non-EEA countries to 
which your data may be transferred may not offer an adequate level of protection of 
privacy of personal data. St Jude Medical has taken security measures to ensure your 
personal data will be processed and used in a confidential way. Data may also be used 
to present reimbursement information to public and private payers to advocate changes 
in coverage, coding or reimbursement rates and payment policies.   
 
21. Who is organizing and funding the study? 
This study is being organized and funded by St. Jude Medical. 
 
The < Hospital> will receive payments from St Jude Medical for participating in this 
study and for providing study data.   
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 208 of 211  
22. What expenses may result from my participation in the study? 
You or your insurance will be billed for tests that are standard of care and would be 
done even if you were not taking part in the study. Tests and procedures that will be 
done just for the study will be paid for by the sponsor. 
 
You will receive a stipend in the amount of $25 per visit to cover the cost of travel and 
parking for attending required research related visits. There are a total of 7 required 
visits (baseline, 30 day, 12 month, 2 year, 3 year, 4 year, and 5 year). 
 
23. Who has reviewed the study? 
The study was reviewed by the < hospital system> and has been approved to be 
conducted at this hospital by the <IRB>.  If you have any questions about your rights as a 
research subject you can contact the <IRB > at <contact information >. 
 
24. What are my responsibilities if I am in the study? 
As a study participant, you are asked to follow study requirements, follow medical 
instructions given by your study doctor, inform your study doctor of any changes in your 
health, and inform your study doctor of any other medical care or drugs you are 
receiving (whether prescribed by a physician or bought over the counter). 
 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 209 of 211  
AUTHORIZATION TO USE AND DISCLOSE HEALTH INFORMATION 
 
I agree to permit {add Investigator name here} and staff members and, St. Jude Medical, 
the sponsor of the PORTICO clinical trial to use and disclose health information that 
identifies me for the purposes described below.  I also agree to permit {add 
hospital/clinical study site information here}, my doctors, and my other health care 
providers to disclose health information in my medical records to the researchers, Jude 
Medical and the FDA, or other regulatory bodies for the purposes described below. 
 
1. 
The health information that may be used and disclosed includes: 
• All information collected during the research as described in the Informed 
Consent Form; and 
• Health information in my medical records that is relevant to the research 
described in the Informed Consent Form. 
 
2. 
The researchers may: 
• 
Use and share my health information to conduct the research; 
• 
Disclose my health information to the Sponsor of research, St. Jude Medical 
and its affiliated companies (located in the U.S. and other countries), 
representatives designees that provide services related to the device and/or 
this study; 
• 
Disclose my health information as required by law; 
• 
Disclose my health information to representatives of government 
organizations and other persons who are required to watch over the safety 
and effectiveness of medical products and therapies and the conduct of 
research; and  
• 
Remove from my health information my name and other information that 
could be used to identify me. 
 
3. 
St. Jude Medical and its affiliated companies (located in the U.S. and other 
countries), representatives designees that provide services related to the device 
and/or this study may: 
• Use and share my health information to conduct the research; 
• Disclose my health information as described in the Informed Consent 
• Disclose my health information as required by law;  
• Disclose my health information to representatives of government 
organizations and other persons who are required to watch over the safety 
and effectiveness of medical products and therapies and the conduct of 
research; and  
• Remove from my health information my name and other information that 
could be used to identify me. 
 
4. 
Once information that could be used to identify me has been removed, the 
information that remains is no longer subject to this Authorization and may be 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 210 of 211  
used and disclosed by the researchers and St. Jude Medical and its affiliated 
companies (located in the U.S. and other countries), representatives designees 
that provide services related to the device and/or this study as permitted by law. 
 
5. 
Once my health information has been disclosed to a third party, privacy laws 
may no longer protect it from further disclosure.  However, the researchers and 
St. Jude Medical agree to protect my health information by using and disclosing 
it only as permitted by me in this Authorization and the Informed Consent.  Also, 
no publication about the research will reveal my identity without my specific 
written permission.  These limitations continue even if I revoke (take back) this 
Authorization. 
 
Please note that: 
• You do not have to sign this Authorization, but if you do not, you will not 
be allowed to participate in the research. 
 
• You may change your mind and revoke this authorization at any time. To 
revoke this Authorization, you must write to {name and contact 
information}.  However, if you revoke this Authorization, you will no 
longer be allowed to participate in the research.  Also, if you revoke this 
Authorization, the information already obtained by the researchers and 
St. Jude Medical may be used and disclosed as permitted by the 
Authorization and the Informed Consent. 
 
• While the research is in progress, you will not be allowed to see your 
health information that is created or collected in the course of the 
research.  After the research is finished, however, you may see this 
information as described in the {add hospital/clinical study site name 
here}’s Notice of Information practices.  
 
• This Authorization does not have an expiration (ending) date. 
 
• You will be given a copy of this Authorization after you have signed it. 
 
Thank you for considering taking part in this study. 
 
If you decide to participate you will be asked to sign below and will be given a copy of 
this form to keep. 
 
Name of Principal Investigator: [Insert Name] 
 

 
PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) 
ABBOTT CONFIDENTIAL AND PROPRIETARY 
©2014 –St. Jude Medical Cardiovascular Division (now part of Abbott): All rights reserved. No portion of this work may be 
reproduced in whole or in part without the express written permission of Abbott. 
CL06799 Version L  
 
 
 
 
 
 
 
Page 211 of 211  
1. 
I confirm that I have read and understood the Informed Consent for this Portico IDE 
study. I have had sufficient time to think about it and I have been given the opportunity 
to ask questions, and have had these answered satisfactorily 
2. 
 I understand that:  
• my participation is voluntary and that I am free to refuse to participate in this 
study or to withdraw at any time, without giving any reason and without my 
medical care or legal rights being affected  
• my relationship with my doctor will not be affected if I withdraw 
• there will not be any penalty if I decide to withdraw from the study 
• if I withdraw before the aortic valve replacement procedure, I will not get a St Jude 
Medical Portico valve 
• my attendance at study visits is important to the study and I should follow the 
study doctors instructions 
3. 
I understand that: 
• my medical information,  information collected during the study and study results 
may be looked at, used, and disclosed by responsible individuals from St. Jude 
Medical,  a U.S. company, and its affiliates (located in the U.S. and other countries, 
and other people who work for St. Jude Medical to provide services related to the 
device and this study, regulatory authorities, the IRB and, when it is relevant to my 
taking part in this research. I give permission for these individuals to have access to 
my medical information, information collected during the study, and study results 
• my data gathered in this study may be stored (after anonymized) in a database and 
may be used and disclosed by St Jude Medical  
• my relevant personal data may be used for the purpose of this clinical study 
• data collected from the time I sign this document until the time I withdraw from 
the study will be used after I withdraw 
• I will not financially benefit from this study 
• I may be responsible for insurance copayments 
4. 
I understand how to contact the research team 
5. 
I agree to my General Practitioner being informed of my participation in the study 
6. 
I understand the risks of aortic valve surgery and the risks of participating in this study and  
7. 
I am willing to participate in this study 
 
Name of Participant (please print) 
Signature 
Date 
Time____________ 
 
Name of Person Obtaining Consent (please print) 
Signature 
Date 
Time__________