Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
Phase: NA
Conditions: Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure, Coronary Artery Disease
Sponsor: Edwards Lifesciences

Edwards Lifesciences LLC 
One Edwards Way  Irvine, CA USA  92614 
Phone: 949.250.2500  Fax: 949.250.2525  www.edwards.com 
Clinical Trial of the Edwards Aortic Bioprosthesis, 
Model 11000 
NCT01651052 
May 8, 2012 

Edwards Pericardial Aortic Bioprosthesis, Model 11000
   
Clinical Trial Number: 2010‐03 
 
Revision C: 8 MAY 2012 
Confidential
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Clinical Trial of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 
 
 
 
 
 
 
 
CLINICAL PROTOCOL 
(Clinical Investigational Plan) 
 
Clinical Trial Number: 2010‐03 
Revision: C 
Effective Date: May 8, 2012 
 
 
  
 
 
 
 
 
 
 
Trial Sponsor: 
Edwards Lifesciences LLC 
One Edwards Way 
Irvine, CA 92614 USA 
 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used 
or disclosed without written permission from Edwards Lifesciences LLC 
 
Edwards Lifesciences, Edwards, the stylized E logo, Carpentier‐Edwards, Magna Ease, PERIMOUNT, PERIMOUNT Magna, and 
ThermaFix are trademarks of Edwards Lifesciences Corporation.  

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Clinical Trial Number: 2010‐03 
 
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1   PROTOCOL SIGNATURE PAGE 
Trial Title: 
Clinical Trial of the Edwards Pericardial Aortic Bioprosthesis, 
Model 11000 
Protocol Number:     2010‐03 
Version Number:     Rev. C  
Date: 
8 MAY 2012 
 
I have read this protocol and agree to participate in the clinical investigation of the Model 11000 
sponsored by Edwards Lifesciences, LLC.  I agree to conduct this investigation according to the 
requirements of the trial protocol and in accordance with Good Clinical Practice, applicable 
State and U.S. Federal regulations and conditions imposed by the reviewing Institutional Review 
Board/Ethics Committee/Research Ethics Board.  I agree to supervise all sub‐investigators at my 
site as well as the use of all of the investigational devices at my institution and to ensure 
appropriate informed consent is obtained from all subjects prior to inclusion in this trial.   
 
    
INVESTIGATOR NAME 
 
INVESTIGATOR TITLE 
INVESTIGATOR SIGNATURE 
 
DATE 
SPONSOR NAME 
 
SPONSOR TITLE 
SPONSOR SIGNATURE 
 
DATE 

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2   TRIAL CONTACT PERSONNEL 
2.1  SPONSOR CONTACT 
TRIAL DIRECTOR 
  PROJECT MANAGER  
 
Director, HVT Clinical Affairs 
One Edwards Lifesciences Way      
Irvine, CA 92614 
Tel: 
 
Fax: 
 
Email: 
 
 
 
 
 
 
 
 
 
 
Clinical Manager, HVT Clinical Affairs 
One Edwards Lifesciences Way      
Irvine, CA 92614 
Tel: 
 
Fax:
 
Email: 
 
 
2.2  TRIAL CONTACT  
CLINICAL MONITORING 
  ECHOCARDIOGRAPHY CORE LAB 
D‐Target Premier Research 
Contact:      
 
Tel:
  
Mobile: 
 
Email: 
 
 
 
RadCore Labs 
Contact: 
 
 
Tel: 
 
Fax: 
 
Email:
 
www.radcorelabs.com  
 
Kraków  
  WARSAW 
Prof. Dr. 
 
 
 
 
 
Tel: 
 
Fax: 
 
 
 
 
 
 
 
 
Prof. Dr. 
 
 
 
 
  
Tel: 
 
Fax: 
 
 
 

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Table of Contents 
1  PROTOCOL SIGNATURE PAGE ....................................................................................................... 
2 
2  TRIAL CONTACT PERSONNEL 
......................................................................................................... 
3 
2.1 SPONSOR CONTACT 
................................................................................................................................ 3 
2.2 TRIAL CONTACT 
..................................................................................................................................... 3 
3  PROTOCOL SYNOPSIS ................................................................................................................... 
7 
4  ABBREVIATIONS 
......................................................................................................................... 
10 
5  INTRODUCTION 
.......................................................................................................................... 
11 
5.1 INTRODUCTION AND BACKGROUND 
......................................................................................................... 11 
5.2 DEVICE DESCRIPTION ..................................................................................................................... 11 
5.2.1  Indication for use 
.................................................................................................................. 12 
5.2.2  Prior Testing 
.......................................................................................................................... 12 
5.2.3  Prior clinical studies 
.............................................................................................................. 12 
6  BENEFITS AND RISKS 
................................................................................................................... 
13 
6.1 BENEFITS 
........................................................................................................................................... 13 
6.2 RISKS 
................................................................................................................................................ 13 
7  CLINICAL TRIAL DESIGN............................................................................................................... 
14 
7.1 JUSTIFICATION .................................................................................................................................... 14 
7.2 PURPOSE 
........................................................................................................................................... 14 
7.3 ENDPOINTS 
........................................................................................................................................ 15 
7.3.1  Safety endpoints 
................................................................................................................... 15 
7.3.2  Performance endpoints 
......................................................................................................... 15 
7.3.3  Other Data 
............................................................................................................................ 15 
8  SUBJECT POPULATION 
................................................................................................................ 
15 
8.1 DEMOGRAPHIC AND CLINICAL CHARACTERISTICS 
........................................................................................ 15 
8.2 I
NCLUSION CRITERIA 
............................................................................................................................. 16 
8.3 EXCLUSION CRITERIA 
............................................................................................................................ 16 
8.4 WITHDRAWAL CRITERIA AND PROCEDURES 
............................................................................................... 17 
9  STATISTICAL METHODS 
............................................................................................................... 
18 
9.1 SAMPLE SIZE 
....................................................................................................................................... 18 
9.2 ANALYSIS POPULATION 
......................................................................................................................... 18 
9.3 SAFETY ANALYSIS 
................................................................................................................................. 18 
9.4 PERFORMANCE ANALYSI
S 
...................................................................................................................... 18 
9.5 OTHER DATA 
...................................................................................................................................... 19 
9.6 MISSING DATA 
.................................................................................................................................... 19 
10  TRIAL PROCEDURES 
.................................................................................................................... 
19 
10.1  BASELINE EVALUATION .................................................................................................................... 20 
10.1.1 
Subject screening 
............................................................................................................. 20 
10.1.2 
Informed consent 
............................................................................................................. 20 
10.1.3 
Baseline assessment ........................................................................................................ 20 
10.2  SURGICAL PROCEDURE 
..................................................................................................................... 21 
10.2.1 
Procedure preparation 
..................................................................................................... 21 
10.2.2 
Model 11000 Implanting Procedure ................................................................................ 21 

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10.2.3 
Implant Assessment 
......................................................................................................... 21 
10.3  SUBJECT ENROLLMENT 
..................................................................................................................... 21 
10.4  POST‐
PROCEDURE .......................................................................................................................... 22 
10.4.1 
Post‐procedure care 
......................................................................................................... 22 
10.4.2 
Discharge 
......................................................................................................................... 22 
10.4.3 
Follow‐up assessments .................................................................................................... 22 
10.5  ECHOCARDIOGRAM 
......................................................................................................................... 23 
10.6  DEVICE REMOVAL / EXPLANT 
............................................................................................................. 23 
10.7  MISSED SUBJECT VISITS 
.................................................................................................................... 23 
10.8  TRIAL SUBJECT EXIT 
......................................................................................................................... 24 
10.9  CLINICAL TRIAL TERMINATION ........................................................................................................... 24 
11  ADVERSE EVENTS ....................................................................................................................... 
24 
11.1  REPORTING PROCEDURE .................................................................................................................. 24 
11.2  ADVERSE EVENT DEFINITIONS 
........................................................................................................... 25 
11.2.1 
Adverse event 
................................................................................................................... 25 
11.2.2 
Adverse device effect 
....................................................................................................... 25 
11.2.3 
Serious adverse event ...................................................................................................... 25 
11.2.4 
Serious adverse device effect 
........................................................................................... 25 
11.2.5 
Unanticipated serious adverse device effect 
.................................................................... 25 
11.3  DEATHS AND EXPLANTS 
.................................................................................................................... 25 
11.3.1 
Subject deaths 
.................................................................................................................. 25 
11.4 
CLINICAL EVENTS COMMITTEE 
............................................................................................................ 26 
12  TRIAL AND DATA MANAGEMENT 
................................................................................................ 
26 
12.1  TRIAL CORE LABS ....................................................................................................................... 26 
12.1.1 
ECHOCARDIOGRAPHY CORE LAB...................................................................................... 26 
12.2  DEVICE SHIPMENTS 
......................................................................................................................... 26 
12.3  I
NVENTORY AND ACCOUNTABILITY RECORDS 
......................................................................................... 26 
12.4  DEVICE STORAGE 
............................................................................................................................ 26 
12.5  DEVICE RETURN 
.............................................................................................................................. 27 
12.6  PROTOCOL DEVIATIONS ............................................................................................................ 27 
12.6.1 
Exceptions 
........................................................................................................................ 27 
12.7  TRAINING 
...................................................................................................................................... 27 
12.7.1 
Training of trial site personnel 
......................................................................................... 27 
12.7.2 
Devices 
............................................................................................................................. 28 
12.8  MONITORING 
................................................................................................................................ 28 
12.8.1 
SITE INITIATION 
................................................................................................................ 28 
12.8.2 
monitoring methods ........................................................................................................ 28 
12.9  DOCUMENTATION REQUIREMENTS 
.................................................................................................... 28 
12.9.1 
Source documentation requirements 
............................................................................... 29 
12.9.2 
Data collection methods 
.................................................................................................. 29 
12.9.3 
Quality control and quality assurance procedures 
........................................................... 30 
12.9.4 
communication procedures ............................................................................................. 30 
12.10  PROTOCOL AMENDMENTS 
........................................................................................................ 30 
12.11  AUDITS AND INSPECTIONS 
................................................................................................................ 30 
13  ETHICAL AND REGULATORY CONSIDERATIONS 
............................................................................ 
30 
13.1  APPLICABLE REGULATIONS AND GUIDELINES 
......................................................................................... 30 
13.2 
DATA PROTECTION AND SUBJECT CONFIDENTIALITY 
................................................................................ 31 
13.3  I
NFORMED CONSENT AND REVIEW COMMITTEES 
................................................................................... 31 

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13.4  I
NVESTIGATOR RESPONSIBILITIES 
........................................................................................................ 31 
13.4.1 
General duties 
.................................................................................................................. 31 
13.4.2 
Investigator records 
......................................................................................................... 32 
13.4.3 
Investigator reports ......................................................................................................... 32 
13.5  TRIAL SPONSOR RESPONSIBILITIES ...................................................................................................... 32 
13.5.1 
General duties 
.................................................................................................................. 32 
13.5.2 
Selection of investigators 
................................................................................................. 33 
13.5.3 
Monitoring the clinical trial 
.............................................................................................. 33 
13.5.4 
Sponsor records 
................................................................................................................ 33 
13.5.5 
Sponsor reports 
................................................................................................................ 33 
13.6  PUBLICATION POLICY 
....................................................................................................................... 33 
14  REFERENCES 
............................................................................................................................... 
34 
15  APPENDICES 
............................................................................................................................... 
34 
15.1  ADVERSE EVENT (
CODES AND DEFINITIONS) ......................................................................................... 35 
15.2  SAMPLE INFORMED CONSENT FORM 
................................................................................................... 36 
15.3  CASE REPORT FORMS 
....................................................................................................................... 37 
15.4 
PROTOCOL DEVIATION CODES 
............................................................................................................ 38 
15.5  DEVICE DEFICIENCY CODES 
.............................................................................................................. 39 
15.6 
ECHO MANUAL 
............................................................................................................................... 40 
15.7  EQ‐5D QUESTIONNAIRE 
.................................................................................................................. 41 
15.8  SF‐12 V2 QUESTIONNAIRE .............................................................................................................. 42 
 

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3 PROTOCOL SYNOPSIS 
 
Trial Number: 
2010‐03 
Title: 
Clinical trial of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 
Trial Sponsor:  
Edwards Lifesciences LLC 
One Edwards Way, Irvine, CA 92614 USA 
Krakow Principal 
Investigator: 
 
 
Warsaw Principal 
Investigator: 
 
 
Trial 
Purpose: 
The purpose of this observational trial is to gather further clinical data to 
confirm the safety and performance of the Edwards Pericardial Aortic 
Bioprosthesis, Model 11000 in this trial population. 
Trial Device: 
Edwards Pericardial Aortic Bioprosthesis, Model 11000. An identical valve 
model, Model 11000A, has labeling that bears the CE marking of 
conformity under EC Design‐Examination Certificate No. 2103732DE04 
and CE Marking of Conformity Certificate No. 2103732CE04. 
Intended Use: 
The Model 11000 valve is intended for subjects who require replacement 
of their native or prosthetic aortic valve. 
Trial Design: 
This is a prospective, non‐randomized, non‐controlled, observational 
clinical trial.  
Up to 200 subjects will be enrolled at up to 6 participating trial sites. Each 
subject is consented for a period of 5 years. All subjects will be assessed 
clinically at the following intervals: Baseline, Implant, discharge, 3 
months, and annually to 5 years. 
Population: 
Adult subjects diagnosed with aortic valve disease requiring replacement 
of the native or prosthetic aortic valve. 
Enrollment 
Criteria: 
Inclusion Criteria 
  Is 18 years or older 
  Provides written informed consent prior to trial procedures 
  Diagnosed with aortic valve disease requiring a planned replacement 
as indicated in the preoperative evaluation 
  Scheduled to undergo planned aortic valve replacement with or 
without concomitant bypass surgery 
  Geographically stable and agrees to attend all follow‐up assessments 
at the hospital of surgical services for up to 5 years 

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Exclusion Criteria 
Requires emergency surgery
1
Has prior mitral, tricuspid or pulmonic valve surgery, which included
implant of a bioprosthetic valve, mechanical valve, or annuloplasty
ring that will remain in situ
Requires multiple valve replacement/repair
Requires a surgical procedure outside of the cardiac area (e.g.
vascular bypass)
Has aneurysm of the aortic root and/or ascending aorta requiring
surgical intervention
Has active endocarditis/myocarditis or endocarditis/myocarditis
within 3 months to the scheduled aortic valve replacement (AVR)
surgery
Has renal insufficiency as determined by creatinine (S‐Cr) level ≥ 2.5
mg/dL or end‐stage renal disease requiring chronic dialysis at
screening visit
Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA)
or transient ischemic attack (TIA) within 6 months (180 days) prior to
AVR surgery
Has acute myocardial infarction (MI) within 30 days prior to AVR
surgery
Has presence of non‐cardiac disease limiting life expectancy to less
than 12 months
Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM)
Diagnosed with hyperparathyroidism
Exhibits left ventricular ejection fraction  ≤ 30% as validated by
diagnostic procedure within 30 days prior to AVR surgery
Echocardiographic evidence of an intra‐cardiac mass, thrombus, or
vegetation
Hemodynamic or respiratory instability requiring inotropic support,
mechanical circulatory support, or mechanical ventilation within 60
days prior to AVR surgery
Documented leukopenia (WBC < 3.5x 103/µL), acute anemia (Hgb <
10.0 gm/dL or 6 mmol/L), thrombocytopenia (platelet count <
50x103/µL) or history of bleeding diathesis or coagulopathy
Diagnosed with myxomatous disease/connective tissue disorders (e.g.
Marfan’s Syndrome)
Has prior organ transplant
Current or recent participation (within 6 weeks prior to surgery) in an
investigational drug or device trial
Was previously implanted with trial device2
1  Emergent surgery – surgery is carried out on the referral day before the beginning of the next working 
day. 
2 Note: Previously implanted means that the index aortic valve replacement procedure was completed. The 
procedure is complete when the surgeon takes the subject off cardiopulmonary bypass and restarts the heart. 

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 Pregnant (female subject of childbearing potential only), lactating or 
planning to become pregnant during the duration of participation in 
trial 
 Currently incarcerated or unable to give voluntary informed consent 
 Documented history of substance (drug or alcohol) abuse within the 
last 5 years prior to implant 
Trial Endpoints: 
Safety Endpoints:  
Descriptive information of early rates and late linearized rates of the 
following: 
 Structural valve deterioration 
 Thromboembolism 
 All bleeding/hemorrhage 
 Major bleeding/hemorrhage 
 All paravalvular leak 
 Major paravalvular leak 
 Non‐structural valve dysfunction 
 Endocarditis 
 Hemolysis 
 All cause mortality 
 Trial valve‐related mortality 
 Explant 
Performance Endpoints: 
  Clinically acceptable hemodynamic performance confirmed by core 
lab evaluation of echocardiography 
  New York Heart Association (NYHA) functional class compared to 
baseline 
  Change in Quality of Life questionnaires EQ‐5D (EuroQol) and Short 
Form 12 version 2 (SF‐12v2) from baseline/screening to 1‐year 
Other data: 
Blood Data 

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4 ABBREVIATIONS 
ACC   American College of Cardiology 
     
AE    Adverse Event 
IFU  Instructions for Use 
AHA   American Heart Association 
INR  International Normalized Ratio 
AS    Aortic Stenosis 
IRB  Institutional Review Board 
ASD   Atrial Septal Defect 
ISO  International Standardization Organization 
AVR   Aortic Valve Replacement 
LVOTLeft Ventricular Outflow Tract 
CABG  Coronary Artery Bypass Graft 
MI  Myocardial Infarction 
CBC   Complete Blood Count 
MOF Multi‐system Organ Failure 
CEC   Clinical Events Committee 
MR  Magnetic Resonance 
CFR   Code of Federal Regulations 
NSVDNonstructural Valve Dysfunction 
CO/CI  Cardiac Output/Cardiac Index 
NYHANew York Heart Association 
CRF   Case Report Form 
OPC Objective Performance Criteria 
CV    Critical Value 
PFO Patent Foramen Ovale 
CVA   Cerebrovascular Accident 
PMA Premarket Approval  
DIC    Disseminated Intravascular Coagulation      
POD Postoperative Day 
EC    Ethics Committee 
PT  Prothrombin Time 
eCRF   Electronic Case Report Form 
PTFE Polytetrafluoroethylene 
ECG   Electrocardiogram 
PTT Partial Thromboplastin Time 
EDC   Electronic Data Capture 
PVL Paravalvular Leak 
EOA   Effective Orifice Area 
QOL Quality of Life 
EQ‐5D   EuroQol health questionnaire 
RBC Red Blood Cell  
FDA   Food and Drug Administration 
REB Research Ethics Board 
FMEA  Failure Modes and Effects Analysis 
RGA Returned Good Authorization 
GCP   Good Clinical Practice 
SAE Serious Adverse Effect 
GLP   Good Laboratory Practices 
SAR Specific Absorption Rate 
HGB   Hemoglobin 
SAVRSurgical Aortic Valve Replacement 
HIPAA  Health Insurance Portability & Accountability Act  SF‐12Short Form 12 health questionnaire 
HCT   Hematocrit 
SVD Structural Valve Deterioration 
HIT    Heparin Induced Thrombocytopenia 
TAD Tissue Annulus Diameter  
HOCM  Hypertrophic Obstructive Cardiomyopathy      TEE  Transesophageal Echocardiography  
ICF    Informed Consent Form 
TIA  Transient Ischemic Attack  
ICU    Intensive Care Unit 
UADEUnanticipated Adverse Device Effect  
ID     Identification 
WBC White Blood Cell  
IDE    Investigational Device Exemption 
     

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5 INTRODUCTION 
5.1  INTRODUCTION AND BACKGROUND 
Valvular heart disease is a life‐threatening disease that afflicts millions of people worldwide and 
leads to approximately 250,000 valve repairs and/or replacements each year. The number of 
subjects requiring aortic valve replacement (AVR) is increasing due to prolonged life expectancy. 
Many subjects are asymptomatic until the disease is well advanced and, once diagnosed, have 
poor prognosis depending on the severity of valve calcification and history of cardiac events.1 
Diseased heart valves can be treated by medication, surgical repair or surgical replacement.  
5.1.1.1 AORTIC HEART DISEASE 
Aortic valvular heart disease includes conditions involving any of the following – obstructions of 
the aortic heart valve or stenosis; leakage of the aortic valve, known as regurgitation, 
incompetence, or insufficiency, and combinations of the two, sometimes referred to as mixed 
disease or combined lesions. Valvular heart disease may be caused by any number of factors, 
including congenital abnormalities, infection by various micro‐organisms, degenerative 
calcification and rheumatic heart disease. When subjects become symptomatic, angina, 
syncope, and congestive heart failure (CHF) are the primary clinical signs observed. Studies 
report that among symptomatic subjects with medically treated moderate‐to‐severe AS, 
mortality rates after the onset of symptoms are approximately 25% at one year and 50% at two 
years. Other studies show that subjects with symptomatic AS have a life expectancy between 2 – 
4 years.
2 Neither aortic stenosis nor aortic insufficiency can be effectively treated medically; 
however, the symptoms of aortic valve disease can be managed medically. 
5.1.1.2 TREATMENT OF AORTIC VALVULAR HEART DISEASE 
Aortic stenosis and insufficiency can be treated by surgical intervention, including balloon 
valvuloplasty, valve repair, and valve replacement.  Balloon valvuloplasty, a treatment option for 
aortic stenosis, utilizes a balloon‐tipped catheter to stretch open the narrowed valve. 
Valvuloplasty is predominately used to treat children or adults who are poor surgical candidates. 
Valve repair techniques include annuloplasty for dilated valve disease, patching leaflet 
perforations, resected vegetations, or tears, and leaflet extension.3,4  Aortic valve repair for 
stenosis does not show good clinical results.
5  Replacement of the aortic valve is indicated for 
symptomatic subjects and asymptomatic subjects with left ventricular dysfunction.  
5.1.1.3 BIOPROSTHETIC HEART VALVES 
Bioprosthetic heart valves are indicated for use in subjects suffering from valvular heart disease. 
These tissue valves are used particularly in those subjects for whom long‐term anticoagulation 
therapy is contraindicated or who may be difficult to maintain on anticoagulation therapy. 
5.2  DEVICE DESCRIPTION 
Refer to the Instructions for Use in the Clinical Investigator’s Brochure (CIB) for a complete 
description of the device.  

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The Edwards pericardial aortic bioprosthesis, Model 11000, is a trileaflet bioprosthesis 
comprised of bovine pericardium that has been preserved in a buffered glutaraldehyde solution 
and mounted on a flexible frame. It is available in sizes 19, 21, 23, 25, 27, and 29 mm. The 
bioprosthesis is stored in non‐liquid packaging. 
The frame is designed to be compliant at the orifice as well as at the commissures. The 
compliance of the commissure supports is intended to reduce the loading shock at the valve 
commissures and free margin of the leaflets. The compliance of the orifice is intended to reduce 
the stress on the leaflets. The compliant orifice concept is based on the physiology and 
mechanics of natural heart valves and reported experience with implantation of unstented 
homografts. 
The lightweight wireform is made of a corrosion‐resistant cobalt‐chromium alloy, chosen 
because of its superior efficiency and fatigue‐resistant characteristics, and is covered with a 
woven polyester fabric.  
A thin cobalt‐chromium alloy/polyester film laminate band surrounds the base of the wireform 
frame providing structural support for the orifice. A silicone‐rubber sewing ring covered with a 
porous, seamless polytetrafluoroethylene (PTFE) cloth attached to the wireform frame, which 
facilitates tissue ingrowth and encapsulation. The aortic sewing ring has been scalloped to 
conform to the natural aortic root. The compliant nature of the sewing ring facilitates 
coaptation between the bioprosthesis and an often irregular or calcific tissue bed.  
To facilitate implantation in patients with small aortic roots, the Model 11000A has a low profile 
height. The sewing ring has three, equally spaced black silk suture markers at the cusp centers to 
aid in bioprosthesis orientation and suture placement.   
The Model 11000 bioprosthesis does not require rinsing prior to implantation.  
A holder is attached to the bioprosthesis by means of sutures to facilitate handling and suturing 
the bioprosthesis during implantation. The holder is easily detached by the surgeon. 
Edwards Pericardial Aortic Bioprosthesis, Model 11000. An identical valve model, Model 
11000A, has labeling that bears the CE marking of conformity under EC Design‐Examination 
Certificate No. 2103732DE04 and CE Marking of Conformity Certificate No. 2103732CE04. 
5.2.1   I
NDICATION FOR USE 
The Model 11000 is intended for patients who require replacement of their native or prosthetic 
aortic valve. 
 
Refer to the Instructions for Use in the Clinical Investigator’s Brochure (CIB) for 
contraindications, procedure steps, and cautions. 
5.2.2   PRIOR TESTING 
A Clinical Investigator’s Brochure (CIB) is prepared for the Model 11000; please refer to this 
document for pre‐clinical testing. 
5.2.3 PRIOR CLINICAL STUDIES 
Twenty (20) subjects are implanted with the Model 11000 Pericardial Bioprosthesis under 
Version A of this ongoing clinical trial. 

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A summary of prior clinical studies on similar pericardial valves are included in the Clinical 
Investigator’s Brochure. 
6  BENEFITS AND RISKS 
6.1  BENEFITS 
The benefits of the Model 11000 are assumed the same as other bioprosthetic valves including 
improved valvular function, acute alleviation of symptoms related to aortic stenosis or 
insufficiency, and/or improved morbidity and mortality.  The additional benefits of this valve are 
not yet proven.  
 The anticipated additional benefits of aortic valve, Model 11000 are to eliminate the need for 
rinsing the index valve prior to implant, less exposure to the risks of glutaraldehyde, and 
elimination of hazardous waste requiring special disposal. 
6.2  RISKS 
As with all prosthetic heart valves, serious complications, sometimes leading to death may be 
associated with the use of tissue valves. Complications due to individual subject reaction to an 
implanted device, or to physical or chemical changes in the components, particularly those of 
biological origin, may occur at varying intervals (hours or days) necessitating reoperation and 
replacement of the prosthetic device. Some or all of the risks listed below could require a 
reoperation or explant, and/or they may lead to permanent disability or death. 
Known/potential risks associated with stented bioprosthetic heart valves include but 
not limited to: 
 Angina 
 Bleeding diatheses (coagulopathy) related to 
anticoagulant therapy 
 Cardiac arrhythmias 
 Cardiac failure 
 Coronary ostial blockage 
 Endocarditis 
 Hemolysis/Hemolytic anemia 
 Hemorrhage 
 Immunological response 
 Leaflet entrapment (impingement) 
 Myocardial infarction 
 Nonstructural valve dysfunction 
 Paravalvular/Perivalvular leak 
 Malfunctions of valve due to distortion at 
implant, fracture of wireform, physical and or 
chemical deterioration of valve components 
 Patient prosthetic mismatch (PPM) 
 Regurgitation/insufficiency  
 Stenosis 
 Thromboembolism/stroke 
 Tissue deterioration including infection, 
calcification, thickening, perforation, 
degeneration, suture abrasion, instrument 
trauma, and or leaflet detachment 
 Transient ischemic attack (TIA) 
 Valve pannus 
 Valve thrombosis 
 

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Potential risks associated with aortic valve replacement surgery include but not limited to: 
 Allergic reaction 
 Annular dissection 
 Aortic dissection 
 Arterial dissection  
 Bleeding, anticoagulant related  
 Bleeding, procedural  
 Bleeding, post‐procedural  
 Cardiac arrest 
 Cardiogenic shock 
 Disseminated intravascular coagulation (DIC) 
 Esophageal rupture 
 Heart failure 
 Hematoma 
 Heparin induced thrombocytopenia (HITs) 
 Hypotension 
 Hypertension 
 Hypoxemia
 Infection, local or wound 
 Infection, systemic (septicemia) 
 Myocardial infarction 
 Multi‐system organ failure (MOF) 
 Pericardial effusion 
 Pericardial tamponade 
 Pleural effusion 
 Pulmonary edema 
 Pneumonia 
 Renal dysfunction 
 Respiratory failure 
 Thromboembolism 
– Venous, peripheral or central 
– Arterial, peripheral or central 
– Pulmonary, thrombus or other 
Risks associated with Model 11000 are anticipated to be the same as those listed above for 
other aortic bioprosthetic valves and valve replacement surgery.  Based on pre‐clinical testing, 
there are no new risks anticipated with the Model 11000 tissue process or sterilization method. 
There may be other unknown risks. All safety events will be collected and reviewed throughout 
the entire trial and follow‐up period. Investigators will be notified of any additional risks 
identified that could affect the health, safety or welfare of the trial subjects. 
7 CLINICAL TRIAL DESIGN 
This is a prospective, non‐randomized, non‐controlled, observational clinical trial. Up to 
200 subjects will be enrolled at up to 6 participating trial sites. Each subject is consented 
for a period of 5 years. All subjects will be assessed clinically at the following intervals: 
Baseline, Implant, discharge, 3 months and annually to 5 years. 
7.1  JUSTIFICATION 
This trial is designed to confirm that the performance observed in pre‐clinical testing 
also is observed in the human population. 
7.2  PURPOSE 
 The purpose of this observational trial is to gather further clinical data to confirm the safety and 
performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial 
population. 

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7.3   ENDPOINTS 
7.3.1 SAFETY ENDPOINTS 
Descriptive information of early rates and late linearized rates of the following: 
  Structural valve deterioration 
  Thromboembolism 
  All bleeding/hemorrhage 
  Major bleeding/hemorrhage 
  All paravalvular leak 
  Major paravalvular leak 
  Non‐structural valve dysfunction 
  Endocarditis 
  Hemolysis 
  All cause mortality 
  Trial valve‐related mortality 
  Explant 
7.3.2 PERFORMANCE ENDPOINTS 
The following performance endpoints will be assessed at each scheduled follow‐up visit:  
 Clinically acceptable hemodynamic performance confirmed by core lab evaluation of 
echocardiography 
 New York Heart Association (NYHA) functional class compared to baseline 
  Change in Quality of Life questionnaires EQ‐5D (EuroQol) and Short Form 12 version 2 (SF‐
12v2) from baseline/screening to 1‐year 
7.3.3 OTHER DATA 
The following blood data also will be collected at baseline, 3 months, and at each annual visit:  
Complete blood count (CBC): including White Blood Cell Count (WBC), Red Blood Cell Count 
(RBC), Hemoglobin (Hgb), Hematocrit (HCT), and platelet count (PLT), and plasma free 
hemoglobin. 
 
Serum creatinine will be collected at baseline only. 
 
Coagulation profile will be collected at baseline, discharge, 3 months, and at the 1, 3, and 5 year 
follow‐up visits. 
8 SUBJECT POPULATION  
8.1  DEMOGRAPHIC AND CLINICAL CHARACTERISTICS 
Adult subjects diagnosed with aortic valve disease and scheduled to undergo aortic valve 
replacement are eligible for participation in the clinical trial.  

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8.2  INCLUSION CRITERIA  
The principal investigator at the trial site has the responsibility of screening potential subjects to 
determine if the patients meet all the inclusion criteria. The following are requirements for entry 
into the clinical trial:  
  Is 18 years or older 
  Provides written informed consent prior to trial procedures 
  Diagnosed with aortic valve disease requiring a planned replacement as indicated in the 
preoperative evaluation 
  Scheduled to undergo planned aortic valve replacement with or without concomitant 
bypass surgery 
  Geographically stable and agrees to attend all follow‐up assessments at the hospital of 
surgical services for up to 5 years 
8.3  EXCLUSION CRITERIA 
The principal investigator at the trial site must exclude subjects if any of the exclusion criteria 
are present. The following are the criteria for exclusion from participating in the clinical trial: 
 Requires emergency surgery
3  
 Has prior mitral, tricuspid or pulmonic valve surgery, which included implant of a 
bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ 
 Requires multiple valve replacement/repair 
 Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass) 
 Has aneurysm of the aortic root and/or ascending aorta requiring surgical intervention 
 Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months to the 
scheduled aortic valve replacement (AVR) surgery 
 Has renal insufficiency as determined by creatinine (S‐Cr) level ≥ 2.5 mg/dL or end‐stage 
renal disease requiring chronic dialysis at screening visit  
 Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic 
attack (TIA) within 6 months (180 days) prior to AVR surgery  
 Has acute myocardial infarction (MI) within 30 days prior to AVR surgery 
 Has presence of non‐cardiac disease limiting life expectancy to less than 12 months 
 Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM) 
 Diagnosed with hyperparathyroidism 
 Exhibits left ventricular ejection fraction  ≤ 30% as validated by diagnostic procedure within 
30 days prior to AVR surgery 
 Echocardiographic evidence of an intra‐cardiac mass, thrombus, or vegetation 
 Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory 
support, or mechanical ventilation within 60 days prior to AVR surgery 
 
3 Emergent surgery – surgery is carried out on the referral day before the beginning of the next working 
day. 

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 Documented leukopenia (WBC < 3.5x 103/µL), acute anemia (Hgb < 10.0 gm/dL or 6 
mmol/L), thrombocytopenia (platelet count < 50x103/µL) or history of bleeding diathesis or 
coagulopathy 
 Diagnosed with myxomatous disease/connective tissue disorders (e.g. Marfan’s Syndrome) 
 Has prior organ transplant 
 Current or recent participation (within 6 weeks prior to surgery) in an investigational drug or 
device trial 
 Was previously implanted with trial device4 
 Pregnant (female subject of childbearing potential only), lactating or planning to become 
pregnant during the duration of participation in trial 
 Currently incarcerated or unable to give voluntary informed consent 
 Documented history of substance (drug or alcohol) abuse within the last 5 years prior to 
implant 
8.4  WITHDRAWAL CRITERIA AND PROCEDURES 
Subjects may voluntarily withdraw consent at any time during the clinical trial with no loss of 
benefit or penalty. Subjects will be exempt from follow‐up after withdrawing from the clinical 
trial. For subjects consented but have withdrawn, the trial site must retain the subject’s 
informed consent and all documents pertaining to the subject prior to the subject’s withdrawal.  
 
The Investigator may withdraw any subject due to any of the following conditions:  
1. Participation in the clinical trial may be contrary to the subject’s current medical treatment, 
based on new information or changes in the subject’s medical condition. 
2. Any anatomical findings that would determine subject not suitable for implant with the 
Edwards aortic valve, Model 11000, which are discovered, intra‐operatively. These may 
include findings such as: 
a. The position of the coronary ostia relative to the Edwards aortic valve, Model 
11000 would result in obstruction of blood flow, 
b. the subject is hemodynamically unstable during the procedure requiring the 
procedure to be aborted prior to implanting the trial device, 
c. A device is not available in the correct size for the subject; 
 
The Investigator will document the withdrawal of trial subjects and notify the Trial Sponsor 
within five (5) working days. Additional subjects will be screened to replace those subjects who 
are withdrawn by the Investigator during the surgical procedure prior to implant.  
 
Edwards will inform the Investigator of any new information about the trial that may affect the 
health, safety or welfare of the subjects or that may influence subject’s decision to continue 
participating in the trial. 
 
4 Note: Previously implanted means that the index aortic valve replacement procedure was completed. The 
procedure is complete when the surgeon takes the subject off cardiopulmonary bypass and restarts the heart. 

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9 STATISTICAL METHODS 
9.1  SAMPLE SIZE  
Up to 200 subjects will be enrolled in the trial at up to 6 participating sites.  
9.2  ANALYSIS POPULATION 
The analyses of safety data will include all enrolled subjects. Subjects are considered enrolled in 
the clinical trial after meeting the enrollment criteria, signing the informed consent and the 
surgeon determines that the index valve can be implanted.  
The analyses of performance data will include the index valve population, defined as all subjects 
that are enrolled into the trial and that are implanted with the index valve. 
9.3  SAFETY ANALYSIS 
Early adverse events within 30 days of procedure will be reported as the number of events 
divided by the number of enrolled subjects. Linearized rates will be used to summarize adverse 
events for the late (>30 days) post‐operative period. The linearized rates will be calculated as 
the number of late events divided by the total number of late‐subject years.  
Percentages for the early events and linearized rates for the late events also will be calculated 
for all other complications observed in the trial. 
Actuarial rates based on the method of Kaplan‐Meier will be calculated for each of the safety 
endpoints at each of the follow‐up time points. 
9.4  PERFORMANCE ANALYSIS 
Hemodynamic Variables 
Valvular regurgitation will be summarized by the number and percentage of subjects in each 
level of regurgitation.  Other hemodynamic parameters will be summarized by N, mean, and 
standard deviation. These summaries will be summarized at baseline and each applicable 
follow‐up visit for all subjects in the investigational valve population, and will be stratified by 
valve size. 
 
NYHA Class 
A comparison of preoperative and postoperative NYHA functional class (presented as the 
percentage of subjects in each class at baseline, at each follow‐up time‐point, and as the 
percentage of subjects at each follow‐up time‐point who improved, worsened, or did not 
change in class) will be presented.  This comparison will be based on the investigational valve 
population.  Additionally, a cross‐tabulation of baseline vs. 1‐year NYHA Class will be presented 
for all subjects in the investigational valve population with both baseline and 1‐year NYHA data. 
 
Quality of Life 
The number, mean and standard deviation for the Quality of Life (EQ‐5D) summary 
measurement will be presented at the pre‐procedure and at the 1‐year post procedure follow‐
up visit. In addition, the number and mean for the change from pre‐procedure to the 1‐year 
post procedure follow‐up visit will be calculated and presented. 
 

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The number, mean, and standard deviation for the SF‐12 physical and mental health summary 
measures (PCS‐12 and MCS‐12, respectively) will be calculated at the pre‐procedure and at the 
1‐year pos procedure follow‐up visit. In addition, the number and mean for the change from 
pre‐procedure to the 1‐year follow‐up in PCS‐12 and MCS‐12 will be presented.  
 
9.5  OTHER DATA 
The mean and standard deviation of blood data will be calculated and presented. 
9.6  MISSING DATA 
All analyses will apply to any available valid data. No data imputation will be performed for 
missing data. 
10 TRIAL PROCEDURES 
Table 3 summarizes all procedures to be conducted during the trial. 
 
Table 3:  Summary of Trial Assessments  
 Trial Procedure 
Baseline Implant Discharge 3 months 1, 3, 5 
year 
2 & 4 
years 
 Written Informed Consent 
X                               
 Pregnancy Test 
X                               
 Medical History 
X                               
 Medical Evaluation 
X            X      X      X      X 
  Height 
X                               
  Weight 
X            X      X      X      X 
  12‐lead ECG 
X            X      X      X      X 
  NYHA 
X                   X      X      X 
Medications 
X            X      X      X      X 
 Adverse Events 
      X      X      X      X      X 
 Echocardiography1 (TTE) 
X            X      X      X      X2 
 Echocardiography3 (TEE) 
      X                         
 Auscultation 
                              X2 
Quality of Life (EQ‐5D and SF‐12v2)4 
X                          X       
 Blood tests 
                               
  Complete Blood Count5 
X            X     X     X      
 
  X   
  Plasma free hemoglobin 
X            X     X     X      
 
  X  
  Serum Creatinine 
X                               
 Coagulation Profile 
X            X      X      X       
Procedure table notes: 
1   TTE will be the standard echo assessment for the aortic valve  
2  If murmur heard then echo required 
3  TEE intra‐operatively and within 1 hour (from cross clamp removal) to confirm placement of the device 
and confirm initial function 
4  Quality of Life only required at Baseline and at 1‐year post‐procedure 
5   Complete blood count includes red blood cells, white blood cells, hemoglobin, hematocrit, platelet count 

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10.1 BASELINE EVALUATION 
10.1.1 SUBJECT SCREENING  
All subjects diagnosed with aortic valve disease requiring aortic valve replacement seen by 
cardiac surgeons participating in this clinical trial should be pre‐screened for eligibility. All 
subjects who meet initial eligibility requirements will be asked to participate. A Screening Log 
will be provided to the trial sites to maintain a cumulative log of all screened subjects admitted 
for aortic valve replacement by the cardiac surgeons participating in this trial. For subjects listed 
as not eligible for participation in the clinical trial, a reason supporting the disqualification of the 
subject must be entered on the screening log. The Screening Log shall be completed and faxed 
to the Trial Sponsor regularly (at least once per month). Any subject deemed ineligible due to 
active endocarditis, recent myocardial infarction, pregnancy or lactating, or due to participation 
in another clinical trial may be re‐screened later. Re‐screened subjects must be re‐entered on 
the Screening Log.  
10.1.2 I
NFORMED CONSENT  
Subjects who are eligible for participation in the clinical trial shall be provided with patient 
consent information, approved by the site’s ethics committee (EC). Each subject shall be given 
ample time to read the Informed Consent in its entirety and ask questions to make an informed 
decision. The subject must sign and date the trial approved Informed Consent prior to 
participation, i.e. prior to any trial procedures. Subjects who provide informed consent will be 
assigned a trial subject identification number. The Investigator, or designee, and any witnesses 
shall also sign and date the consent form, as applicable. Failure to provide Informed Consent 
renders the subject ineligible for participation in the clinical trial including undergoing treatment 
with the trial device. Subjects who do not provide informed consent are recorded on the 
Screening Log.  
10.1.3 BASELINE ASSESSMENT 
After a written informed consent has been obtained from the subject the following baseline 
data will be obtained (see Table 4); demographic and medical history, 12‐lead 
electrocardiogram (ECG), transthoracic echocardiograph (TTE) per protocol, blood studies per 
protocol, an assessment of NYHA Functional Classification, Quality of Life (EQ‐5D and SF‐12v2), 
and coagulation profile (via INR or PTT). Test results conducted within 30 days before aortic 
valve surgery may be used for this trial if all values per protocol are available and there has been 
no significant change in the subject’s condition that would affect the test results.  
 
Table 4 Baseline Assessment 
Clinical/Physical Assessment 
Blood Studies      
Echocardiography (TTE) 
Date of Assessment 
Date of Birth 
Sex/Gender 
Height 
Weight 
Heart Rate 
Blood Pressure  
Cardiac Rhythm (12‐lead ECG) 
NYHA Classification 
Quality of Life (EQ‐5D & SF‐12v2) 
Anti‐thromboembolic 
Therapy 
(medications)  
Cardiovascular Risk Factors 
Cardiovascular Conditions 
Previous Procedures / 
Interventions 
Non‐Cardiovascular 
Conditions 
Pregnancy Test 
Blood Draw Date 
White Blood Cell Count 
Red Blood Cell Count 
Hemoglobin 
Hematocrit 
Platelet Count 
Plasma Free 
Hemoglobin 
Serum Creatinine 
Coagulation Profile 
Date of Exam 
 
 
REFER TO ECHO MANUAL 
 
 

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10.2    SURGICAL PROCEDURE       
10.2.1 PROCEDURE PREPARATION 
The surgical approach used will be at the discretion of the investigator per his/her routine 
surgical practice. At the time of aortic valve replacement, a transesophageal echocardiogram to 
further assess the anatomy is recommended prior to aortic valve (to ensure no withdrawal 
criteria are met per section 8.4). After performing the aortotomy, the native valve and 
surrounding anatomy should be examined for compatibility with the device again to ensure no 
withdrawal criteria are met. 
10.2.2 MODEL 11000 I
MPLANTING PROCEDURE 
A detailed description of device preparation and use is provided in the Instructions for Use (IFU), 
(See Clinical Investigator’s Brochure). Investigators must be familiar with Precautions and 
Implant Technique described in the IFU prior to use of the index valve.  
10.2.3 I
MPLANT ASSESSMENT 
A Transesophageal echo (TEE) should be performed within 1 hour after the index valve is 
implanted (from cross clamp removal) to assess placement and index valve function. The echo 
requirements are in the Echo Manual. 
 
Procedural information, findings, results and device identification information to be recorded is 
identified in Error! Reference source not found.. 
 
Table 5 :Procedural information 
General information    Clinical information 
Device performance 
Date of Admission 
Date of Procedure 
Implanting Surgeon 
Type of Operation 
 
Etiology 
Diagnosis for replacement 
Valve implant 
Condition of the native aortic valve 
Sizing 
Concomitant procedures 
Intraoperative Adverse Events 
Valve size and serial number 
Post‐operative TEE (within 1 
hour) 
REFER TO ECHO MANUAL 
10.3 SUBJECT ENROLLMENT 
Subjects will be considered enrolled in the clinical trial after meeting the enrollment criteria, 
signing the informed consent and the surgeon determines that the index valve can be 
implanted. The point of enrollment in the clinical trial is established in the Operating Room 
when the investigator confirms that the subject is an appropriate candidate for the index valve 
or trial device and attempts to implant the valve. Additional subjects will not be enrolled to 
replace those subjects implanted with the index valve who choose to withdraw from the clinical 
trial. 

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10.4 POST‐PROCEDURE 
10.4.1 POST‐
PROCEDURE CARE 
At the discretion of the investigator, bioprosthetic heart valve recipients should be maintained 
on anticoagulant therapy (except when contraindicated) during the initial healing stages after 
implant, approximately 2 to 3 months in accordance with the ACC/AHA 2008 Guidelines for the 
Management of Patients with Valvular Heart Disease.6 Anticoagulants should then be 
discontinued over a period of 10 days, except in those patients for whom ongoing anticoagulant 
protection is indicated, i.e. in the absence of sinus rhythm and in patients with a dilated left 
atrium, calcification of the atrial wall, history of previous atrial thrombus, or any other medical 
condition requiring anticoagulation therapy. However, the appropriate anticoagulation therapy 
must be determined by the physician on an individual basis. 
10.4.2 DISCHARGE 
Table 6 identifies the medical information and clinical evaluation of trial subjects at discharge, 
which includes an echocardiogram (refer to Section 10.5). 
 
Table 6 Discharge Information 
Clinical/Physical Assessment     Blood Studies 
Echocardiography (TTE) 
Date of Discharge 
Weight 
Heart Rate 
Blood Pressure  
Cardiac Rhythm (12‐lead ECG) 
Anti‐thromboembolic Therapy 
(medications) 
Adverse Events 
Blood Draw Date 
White Blood Cell Count 
Red Blood Cell Count 
Hemoglobin 
Hematocrit 
Platelet Count 
Plasma Free Hemoglobin 
Coagulation Profile
Date of Exam 
 
REFER TO ECHO MANUAL 
 
Subjects, who are not discharged within 10 days post procedure must have an echocardiogram 
(refer to Section 10.5) to further assess placement and performance of the index valve. This 
echocardiogram is required to complete the evaluation of valve short‐term function. Those 
subjects will not require an additional echocardiogram at discharge. 
10.4.3 FOLLOW‐
UP ASSESSMENTS 
Post‐procedure clinical evaluation will be performed on all enrolled trial subjects at scheduled 
visits at the trial site.  The follow‐up windows are listed in Table 7. 
 
Table 7: Follow‐up Windows
Follow‐up Assessment* 
Assessment Window 
3 months 
± 1 month
1 year 
± 1 month
2 years 
± 3 month
3 years 
± 3 month
4 years 
± 3 month
5 years 
± 3 month
*Follow‐up visits are calculated from the implant date. 

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During each postoperative follow‐up visit, the investigator(s) will determine the subject's 
availability for future follow‐up visits. If any subject needs to be seen, at a time other than a 
regularly scheduled follow‐up visit, due to an index device related event, the required data 
collection would be the same as the 1 year follow‐up evaluation. 
 
Table 8 Follow‐Up Information at all Post‐Discharge Visits (3 months and annually to 5 years) 
Clinical/Physical Assessment     Blood Studies 
Echocardiography (TTE)
3  
Date of Discharge 
Physical Assessment 
Cardiac Rhythm (12‐lead ECG) 
NYHA Classification 
Quality of Life (EQ‐5D & SF12‐v2)
1 
Anti‐thromboembolic Therapy 
(medications) 
Adverse Events 
Blood Draw Date 
White Blood Cell Count 
Red Blood Cell Count 
Hemoglobin 
Hematocrit 
Platelet Count 
Plasma Free Hemoglobin 
Coagulation Profile2 
Years 1, 3, 5:
Date of exam 
SEE ECHO MANUAL 
Years 2, 4: 
Date of exam 
Auscultation4 
 
1 Quality of Life (EQ‐5D and SF12‐v2) will be completed only at the 1‐year follow‐up visit 
2 Coagulation profile will be completed only at years 1, 3, and 5 
3 Exam to be performed as described in the Echo Manual. Data evaluation performed by a Core Lab. 
4 TE will be the standard echo assessment for the aortic valve but will only be completed if murmur is heard on 
auscultation at year 2 and year 4 interval visits. 
10.5 ECHOCARDIOGRAM  
Echocardiograms will be independently analyzed by the Echocardiography Core Lab. Each 
sonographer participating in the clinical trial must be trained on the requirements of the Echo 
Manual.      
10.6 DEVICE REMOVAL / EXPLANT  
Index valve ‘removal’ is the excision of the investigational valve, before implant of the 
investigational valve is complete, i.e., the heart is not restarted with the investigational valve in 
place. If the surgeon is unable to satisfactorily position or sew in the index valve, it will be 
removed and returned to the trial Sponsor who will provide a return valve kit.  If the heart is 
restarted, the valve will be considered implanted and if removal is required from this point 
forward, it will be considered an explant. 
In the event a valve is explanted, a copy of the procedure report must be provided to the trial 
Sponsor. Information on the cause of explant and its relationship to the valve will be provided 
by the investigator(s). Explanted valves must be returned to the trial Sponsor for analysis. 
Return kits for devices will be provided by the trial Sponsor. 
10.7 MISSED SUBJECT VISITS 
The Investigator(s) will make every attempt to follow the subjects and subjects will be 
encouraged by the Investigator(s) to report any address or telephone number changes to the 
trial site. They will also be informed of the importance of returning for scheduled follow‐up visits 
even if they are not having any problems. 
 

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If a subject cannot be reached for a follow‐up visit, the Investigator will document on the CRF, 
the efforts undertaken to contact the subject or the subject’s primary health care provider. 
These efforts should include 2 attempts of telephone contact at separate dates and times, and a 
registered letter before the end of the follow‐up window. If a subject cannot be reached for a 
follow‐up visit, or misses a scheduled visit, the visit will be recorded as a missed visit on the date 
of last attempted contact. Subjects who miss a visit will not be considered withdrawn. At the 
next visit interval, the Investigator and/or designee will attempt to contact the subject again for 
follow‐up. Should this attempt to contact the subject fail, a family member should be contacted 
in addition to the subject. Subjects who miss 2 sequential follow‐up visits will be considered lost 
to follow‐up at the second missed visit and exempt from further trial follow‐up. After the 
subject is terminated from the trial, the Investigator will attempt to determine if the subject is 
alive, including searching national mortality registries as permitted by local laws. 
10.8 TRIAL SUBJECT EXIT 
Trial Subjects exit the trial when no additional follow‐up visits, procedures, or data collection are 
required. A subject is exited from the trial in the following instances: 
  Subject fails enrollment criteria after written consent  
  Subject is considered enrolled as “intent to treat” however surgeon is unable to 
complete the implant procedure* 
  Subject has trial device explanted* 
  Subject is lost‐to‐follow‐up  
  Subject withdraws from the trial  
  Subject death  
  Subject completes trial follow‐up  
 
* Subjects will be followed for 30 days or until any adverse events experienced by this cohort 
are resolved and then will be exited from the trial.  
10.9 CLINICAL TRIAL TERMINATION 
The principal investigator(s) will be notified in writing upon termination of the clinical trial. The 
Trial Sponsor retains the right to suspend or terminate this clinical trial at any time. Upon trial 
termination, the Investigator will contact the trial subjects to perform a final follow‐up 
assessment within 2 months of trial termination. If a subject completed a protocol scheduled 
clinical evaluation within 6 months prior to trial termination, the final follow‐up assessment may 
be completed by telephone. Subjects should continue seeing their physicians as part of routine 
clinical follow‐up after heart valve replacement surgery. 
11 ADVERSE EVENTS 
11.1 REPORTING PROCEDURE 
Adverse event information will be reported throughout the clinical trial as they occur. Adverse 
events will be followed until they are adequately resolved or explained. The investigator(s) 
should report any serious adverse event to the Trial Sponsor’s Clinical Research department 
within 48 hours after the investigator’s first knowledge of the event, followed by a written 
report  in  ten  working  days.  Notification  should  be  done  via  email  to 
HVTClinicalResearch@edwards.com or faxed to +1 (949) 250‐5010. In addition, trial sites will 

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report all adverse events to their local EC in accordance with the review committee’s 
requirements. 
11.2 ADVERSE EVENT DEFINITIONS 
11.2.1 ADVERSE EVENT  
An adverse event (AE) is defined in ISO 14155:2011 (referred to hereafter as IS0 14155) as any 
untoward medical occurrence in a subject. 
11.2.2 ADVERSE DEVICE EFFECT  
An adverse device effect (ADE) is defined in ISO 14155 as any untoward or unintended response 
to a medical device. This definition includes any event resulting from insufficiencies or 
inadequacies in the instructions for use or the deployment of the device or any event that is a 
result of user error.    
11.2.3 SERIOUS ADVERSE EVENT  
A serious adverse event (SAE) is defined in ISO 14155 an adverse event that:  led to death, led to 
a serious deterioration in the health of the subject that resulted in a life‐threatening illness or 
injury, resulted in a permanent impairment of a body structure or a body function, required in‐
patient hospitalization or prolongation of existing hospitalization, or resulted in medical or 
surgical intervention to prevent permanent impairment to body structure or a body function, or 
led to fetal distress, fetal death or a congenital abnormality or birth defect.  
11.2.4 SERIOUS ADVERSE DEVICE EFFECT 
A serious adverse device effect (SADE) is defined in ISO 14155 as an adverse device effect that 
resulted in any of the consequences characteristics of a serious adverse event or that might 
have led to any of these consequences if suitable action had not been taken or intervention had 
not been made or if circumstances had been less opportune. 
11.2.5 UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECT 
An unanticipated serious adverse device effect (USADE) is defined as serious adverse device 
effect, which by its nature, incidence, severity or outcome is not identified in the Clinical 
Investigator’s Brochure. 
11.3 DEATHS AND EXPLANTS 
11.3.1 SUBJECT DEATHS 
In the event of subject death, every effort should be made to obtain a copy of the autopsy 
report and/or death summary. Information on the cause of death and its relationship to the 
device used in this clinical trial will be determined by the principal investigator. Copies of an 
autopsy report, if available, and/or a death summary are to be sent to the Trial Sponsor. 
 
 
If a device is explanted during autopsy, the device should be returned to the Trial Sponsor for 
analysis. Return kits for devices will be provided upon request by the clinical monitor.  

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11.4 CLINICAL EVENTS COMMITTEE 
The Clinical Events Committee (CEC) evaluates adverse events that are endpoint related. The 
CEC adjudicates events for their relatedness to the investigational device and/or the surgical 
procedure. The CEC will be composed of physicians familiar with the treatment of valvular heart 
disease and cardiac surgery who are not participating in the investigational trial. 
The trial Sponsor will provide the CEC completed case report forms and any relevant source 
documentation/subject information as provided by the clinical site investigators. Trial Sponsor 
will insure that all information is de‐identified before presenting to the committee. The CEC 
documents its findings or rulings on each event. All meeting minutes and supporting 
documentation are maintained by the CEC administrator with a copy provided to the trial 
Sponsor.  
12 TRIAL AND DATA MANAGEMENT 
12.1 TRIAL CORE LABS 
12.1.1 ECHOCARDIOGRAPHY CORE LAB 
The Echo Core Lab is responsible for independently evaluating echocardiograms submitted 
preoperatively and postoperatively by trial sites, and for reporting of hemodynamic and other 
valvular function results. Echocardiograms will be sent directly from the investigational sites to 
the Echo Core Lab. See Appendix 15.7 for the Echo Core Lab Manual. 
12.2 DEVICE SHIPMENTS 
An initial set of Edwards’s aortic valve, Model 11000 will be shipped to the trial site once the 
following conditions are met: the trial site has obtained Ministry of Health and Ethics Committee 
approval, a signed Clinical Trial Agreement is in place, and the Site Initiation Visit, including 
Principal Investigator training, has been completed. Additional devices will be sent to the trial 
site as devices are used or as needed. 
12.3 INVENTORY AND ACCOUNTABILITY RECORDS   
All device shipments will have inventory and shipment records. Devices may be hand carried to 
participating trial sites by Trial Sponsor personnel.  Shipment will be accompanied by trial device 
documentation of delivery. The principal investigator(s) or designee will take inventory of the 
product and complete the delivery documentation with receipt date, condition of the device 
and signature.  Both the trial site and the trial Sponsor will retain copies of these documents. 
 
The investigator will maintain a Device Accountability Log of all trial devices received for use 
during this clinical trial. The log will be kept with the documents for the clinical trial and will be 
available for review during Trial Sponsor monitoring visits. 
12.4 DEVICE STORAGE 
The device inventory will be stored in a locked, controlled, cool, dry and clean area as described 
in the Instructions for Use (IFU). This storage area shall be accessible only to the principal 
investigator(s), his/her co‐investigator or approved designee. Only cardiac surgeons identified in 

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the Clinical Trial Agreement and/or on the Delegation of Authority form on file at the Trial 
Sponsor may implant the trial device. 
12.5 DEVICE RETURN  
The principal investigator(s) will be notified in writing upon termination of the clinical trial. All 
unused devices in original package and/or those in opened packages as well as those removed 
from the original package will be returned upon receipt of this notice as described in the IFU. 
The Investigator’s copy of the Device Accountability log must document any unused devices that 
have been returned. Contact Edwards Lifesciences, the Trial Sponsor, for additional instructions. 
12.6 PROTOCOL DEVIATIONS 
A protocol deviation is defined as an event where the Investigator or trial personnel did not 
conduct the trial according to the clinical protocol or the Clinical Trial Agreement.  
 
Deviations shall be reported to the Trial Sponsor regardless of whether medically justifiable or 
taken to protect the subject in an emergency. Subject specific deviations and non‐subject 
specific deviations, (e.g. unauthorized use of a trial device outside the trial, unauthorized use of 
a trial device by a physician who is not listed in the Clinical Trial Agreement, etc.) will be 
reported in writing. Investigators will also adhere to procedures for reporting trial deviations to 
their EC in accordance with their specific EC’s reporting policies and procedures. 
 
For reporting purposes, deviations are classified as major or minor: 
    Major deviations: 
–  Any deviation from subject inclusion and exclusion criteria; 
–  Any deviation from subject informed consent procedures; 
–  Unauthorized use of an trial device outside the trial; 
–  Unauthorized use of a trial device by a physician who is not listed in the Clinical 
Trial Agreement. 
    Minor deviations:   
–  Deviation from a protocol requirement such as incomplete/inadequate testing 
procedures; 
–  Follow‐up performed outside specified time windows. 
12.6.1  EXCEPTIONS 
Some information collected in this trial is not essential to the trial endpoints and will not be 
considered deviation if absent. 
12.7 TRAINING 
12.7.1 TRAINING OF TRIAL SITE PERSONNEL 
Principal investigator(s) and support staff will be trained by the Trial Sponsor on the use of the 
Edwards aortic valve, Model 11000 and accessories, the Protocol, the Clinical Investigator’s 
Brochure, electronic Case Report Forms (eCRF) and Electronic Data Capture (EDC) system, 
device accountability procedures, GCP (Good Clinical Practices) Guidelines and other trial 
documents as applicable. A “Delegation of Authority Form” will be completed at each trial site 
designating which individuals are allowed to perform specific clinical trial related tasks. The 

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delegated tasks will determine what the training requirements are for each member of the trial 
support staff. 
12.7.2 DEVICES 
Each cardiac surgeon participating in the clinical trial must be trained on the use of the device 
and the clinical protocol before screening potential subjects or using the Edwards aortic valve, 
Model 11000.  
12.8 MONITORING 
12.8.1 SITE INITIATION 
Prior to subject enrollment, an initiation visit will be completed at each trial site to ensure the 
following:   
    Ethics Committee and applicable regulatory body approvals have been obtained and 
documented,  
    The investigators and clinical trial personnel are appropriately trained and clearly 
understand the trial,  
    The investigators and clinical trial personnel accept the obligations incurred in 
undertaking this clinical trial. 
    The Delegation of Authority form has been completed properly 
12.8.2 MONITORING METHODS  
The Trial Sponsor will assign a monitor to monitor the progress of the clinical trial at each trial 
site. The monitor will remain in close contact with each trial site throughout the duration of the 
trial to provide any needed materials, (i.e. trial forms) or answer any questions. The monitor will 
be responsible for verifying that the subject signed the consent, reviewing date recorded on the 
eCRF, and visiting each trial site periodically to observe trial progress and compliance with 
clinical protocol and regulations applicable to this clinical trial.  
 
Monitoring visits will be scheduled throughout the duration of the clinical trial between the 
monitor and the principal investigator at a mutually convenient and available time. These visits 
will assure that the facilities are still acceptable, the protocol and investigational plan are being 
followed, the EC has been notified of approved protocol changes as required, complete records 
are being maintained, appropriate timely reports have been made to the Trial Sponsor and the 
EC, device inventory are accounted for and controlled, and the investigator is carrying out all 
agreed activities.  Any personnel changes must be reported to the monitor immediately and a 
training program scheduled and documented.  
 
Periodic monitoring visits will be made at all enrolling trial sites in accordance with center 
enrollment rates. Trial sites should be visited a minimum of once each year by the monitor. 
Upon termination or conclusion of the clinical trial, the monitor will perform a close‐out visit.  
12.9 DOCUMENTATION REQUIREMENTS 
Training will be documented on a training record provided by the Trial Sponsor, which the 
trainee must sign and date. The training of trial support staff must be completed and 

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documented before the staff member may perform the specific clinical trial related tasks 
delegated to them by the Principal Investigator. 
12.9.1 SOURCE DOCUMENTATION REQUIREMENTS 
Clinical regulations require that Investigators maintain information in the clinical trial subject’s 
medical records that corroborate data collected on the eCRF. Some examples of critical 
information to be maintained for review by the regulatory inspectors and Trial Sponsor monitors 
are: 
  Medical history and physical condition of the clinical trial subject before involvement in 
the clinical trial sufficient to verify protocol entry criteria  
  Dated and signed notes in the subject’s medical record on the day of entry into the 
clinical trial.  
  Dated and signed notes, laboratory records, and test reports, from each clinical trial 
subject visit with reference to the eCRF for further information, if appropriate (for 
specific results of procedures and exams). 
  Notations on abnormal lab results, adverse events reported and their resolution. 
  Notes regarding concomitant anticoagulant/antithrombotic medications taken during 
the clinical trial 
  Subject’s condition upon completion of or withdrawal from the clinical trial. 
 
To protect subject confidentiality, the subject’s name must not appear anywhere on the imaging 
media sent to Edwards e.g. for reporting serious adverse events (SAE), or prepared for 
evaluation by the core lab. Each page should be identified with the subject’s unique trial ID 
number. All other subject identifiers (i.e. medical record number, personal number) are to be 
obscured. Original copies of all data must be kept at the site.   
12.9.2 DATA COLLECTION METHODS  
All required data for this trial are to be collected with standardized Case Report Forms (CRF) for 
individual subjects; the eCRF outline is included in Appendix 16.5.  Electronic CRF (eCRF) will be 
utilized for this trial. All eCRF must be electronically signed by the Principal Investigator or co‐
Investigator listed in the Clinical Trial Agreement and Delegation of Authority Log. If for any 
reason the eCRF are unavailable and/or inaccessible, paper CRF will be provided by the Trial 
Sponsor to be completed, signed by the Principal Investigator or designee and submitted to the 
Trial Sponsor. 
 
 
Primary data collection should be drawn from the subject’s hospital chart and operator 
worksheet (source document) reviews. All eCRF must be kept current to reflect subject status 
during the course of the trial.  
 
Case Report Form Instructions will be provided to assist the Investigator(s) and appropriate trial 
staff with the completion of the required eCRF. 
 
Data Management personnel will employ a full‐featured relational Oracle database application 
on a central server. The application provides the capability of data collection remotely through 
the Internet so the participating site personnel may log on to the system securely and enter the 
data. Other data management programming and/or data analyses will be done in the database 

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system through the sponsor’s internal network. All subjects’ data collected in the system will be 
extensively verified through data validation programs, database integrity rules, and trial‐specific 
data entry conventions for data accuracy and logical meaningfulness. Periodic analysis of all 
subjects’ collected data will be performed in order to examine the expected distributions of data 
and to identify outliers for possible data entry errors. 
12.9.3 QUALITY CONTROL AND QUALITY ASSURANCE PROCEDURES 
All data collected for the purposes of the trial must be documented in the subject’s medical 
notes. Copies of relevant procedural records, examinations and laboratory test results should be 
kept on file in the Investigator’s subject files, e.g. a copy of echo examination sent to the core 
lab should be kept with the subject records. Medical notes, eCRF and copies of test results must 
be available at all times for inspection by the trial monitor. 
12.9.4 COMMUNICATION PROCEDURES 
During the course of the clinical trial, all correspondence (letters, records of telephone calls, 
emails and faxes) regarding the trial must be maintained in the trial binder provided by the Trial 
Sponsor. This binder must be made available for monitoring visits or audits. 
12.10 
PROTOCOL AMENDMENTS 
Changes in the protocol may be made only by written amendment agreed upon by the sponsor, 
the regulatory agency, and if pertinent, the EC. As appropriate, the Trial Sponsor will submit 
changes in the protocol to the pertinent regulatory agencies and investigators to obtain EC re‐
approval. 
12.11 
AUDITS AND INSPECTIONS 
In the event that audits are initiated by the sponsor or national/international regulatory 
authorities, the investigator shall allow access to the original medical records and provide all 
requested information. 
13 ETHICAL AND REGULATORY CONSIDERATIONS 
13.1 APPLICABLE REGULATIONS AND GUIDELINES  
The regulations listed in Table 9 must be observed to comply with the Trial Sponsor’s policy for 
conduct of clinical studies; they also represent sound research practice. It is the responsibility of 
the investigator(s) to comply with the requirements set forth in their country specific 
regulations.  

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Table 9:  Applicable Regulations and Guidelines 
Region    Regulation / Guideline 
Europe      - 93/42/EEC European Medical Device Directive (MDD)
- ISO 14155:2011 (Clinical Investigation of Medical Devices for Human Subjects) 
- ISO 5840: 2009 (Cardiovascular implants‐Cardiac valve prostheses) 
- Declaration of Helsinki (2008) 
Canada      - Canadian Medical Device Regulations (CMDR) 
- Canadian Investigational Testing Authorization as defined in the Medical Devices 
Regulation, May 1998 
 
Furthermore, the investigator should use Good Clinical Practice (GCP) and must comply with the 
laws of the country, whichever will afford greater protection to subjects screened for 
participation in the clinical trial and subjects who participate in the trial. 
13.2 DATA PROTECTION AND SUBJECT CONFIDENTIALITY 
The Trial Sponsor is dedicated to maintaining the confidentiality and privacy of subjects who 
volunteer to participate in the clinical trial. Passwords are issued to appropriate personnel to 
insure confidentiality and protection of the database by allowing variable levels of access to the 
computer system. In addition, the principal investigator is responsible for maintaining 
confidentiality throughout the clinical trial. Hard copies of source documentation are to be 
maintained in a secure area with limited access. All subject identifiers will be obliterated from all 
photocopies of source documents that have been removed from the trial site. Subject identifiers 
include, but are not limited to subject’s name, subject’s initials, social security number or 
equivalent, and medical / hospital number. All documents for the clinical trial will identify the 
subject by a subject identification number assigned by the Trial Sponsor. 
13.3 INFORMED CONSENT AND REVIEW COMMITTEES 
All subjects must provide written informed consent in accordance with the local trial site’s EC 
rules and regulations. A copy of the consent form from each center must be forwarded to the 
Trial Sponsor for review and approval prior to submitting it to the EC. Each center must provide 
the Trial Sponsor with a copy of the trial site’s EC approval letter (stating at a minimum, the 
clinical trial name or identification number, protocol revision being approved and an approval 
date) and the informed consent prior to the initiation of enrollment at that center. If yearly 
approvals for the continuation of the trial at each trial site are required, they must also be 
forwarded to the Trial Sponsor. 
13.4 INVESTIGATOR RESPONSIBILITIES 
13.4.1 GENERAL DUTIES 
The investigator shall ensure that all work and services described herein, or incidental to those 
described herein, shall be conducted in accordance with the highest standards of medical and 
clinical research practice and the applicable regulations. The investigator shall be responsible for 
the day to day conduct of the clinical trial and for the safety and well‐being of human subjects 
enrolled. The investigator will provide copies of the current clinical protocol to all staff 
responsible for conduct of the clinical trial. 
 

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The principal investigator is responsible for obtaining EC approval to start the clinical trial at 
his/her trial site.  
 
If there is a change or addition of co‐investigator, an amended Clinical Trial Agreement must be 
completed promptly. 
13.4.2 I
NVESTIGATOR RECORDS 
The principal investigator will maintain accurate, complete, and current records relating to the 
site and their subjects participation in this clinical trial. Records including eCRF and supporting 
data, hardcopies of all blood and diagnostic exams, signed Clinical Trial Agreement, protocols 
and protocol amendments, signed informed consents, device tracking log and use of devices, EC 
approval letters, EC submissions, correspondence, including required reports and other 
documents pertaining to the conduct of the clinical trial must be kept on file by the investigator. 
If the investigator(s) wishes to assign the responsibility for maintaining files to someone else or 
remove them to another location, he/she should consult with the Trial Sponsor in writing as to 
this change. Files for the clinical trial must be maintained in a known location for a period in 
accordance with Edwards Lifesciences record retention requirements. 
13.4.3 I
NVESTIGATOR REPORTS 
The principal investigator will prepare and submit the following accurate and complete reports 
to the Trial Sponsor and EC in a timely manner: 
-  Unanticipated serious adverse device effects (USADE) occurring during the clinical trial 
will be reported immediately (without any delay that could not be justified) after the 
principal investigator first learns of the event.  
-  Serious adverse device effects (SADE) occurring during the clinical trial will be reported 
as described in Section 11.1 
-  Deviation from the clinical protocol. Deviations to protect the subject’s life or physical 
well‐being in an emergency will be reported to the Trial Sponsor within 5 working days 
and the EC within their reporting policy.  
-  Use of devices without informed consent will be reported to the Trial Sponsor within 5 
working days after the use occurs.  
-  A final written report is submitted to the Trial Sponsor and the EC within three months 
of completion or termination of the trial.  
-  Upon request by a reviewing EC or the pertinent regulatory agencies, the principal 
investigator will provide current information about any aspect of the trial. 
13.5 TRIAL SPONSOR RESPONSIBILITIES 
13.5.1 GENERAL DUTIES 
As the sponsor of this clinical trial, Edwards Lifesciences has the overall responsibility for the 
conduct of the clinical trial, including assurance that the trial meets the regulatory requirements 
of the pertinent regulatory agencies. In this clinical trial, Edwards Lifesciences will have certain 
direct responsibilities and will delegate other responsibilities to an Echocardiography Core 
Laboratory.  

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13.5.2 SELECTION OF INVESTIGATORS   
Edwards Lifesciences will select qualified investigators and will ship trial devices to participating 
trial sites only. Edwards Lifesciences will obtain signed investigator agreements and provide the 
Investigators with the information and supplies necessary to conduct the clinical trial. 
13.5.3 MONITORING THE CLINICAL TRIAL  
Edwards will ensure compliance with the signed investigator’s agreement, the protocol 
(investigational plan), the requirements of applicable regulations and guidelines (see section 
13.1), and any conditions of clinical trial approval by the EC and regulatory bodies per written 
monitoring procedures.  
 
Edwards will conduct an immediate investigation of any unanticipated serious adverse device 
effects (USADE). If an event is found to present an unreasonable risk to subjects, participating in 
this clinical trial Edwards will inform investigators as required.  
13.5.4 SPONSOR RECORDS  
Edwards Clinical Research will maintain accurate, complete, and current records relating to this 
clinical trial. Records include eCRF, signed Investigator Agreement, financial disclosure, 
protocols and protocol amendments, signed informed consents, device use, EC approval letters, 
EC submissions, correspondence, including required reports, and other documents. Edwards will 
maintain documentation during the clinical trial and for a period of 100 years after the clinical 
trial is terminated or completed, or the records are no longer required to support a regulatory 
submission. Storage of the records may be designated to a third party.  
13.5.5 SPONSOR REPORTS 
Edwards Clinical Research will prepare and submit the following accurate and complete reports 
to the EC and the pertinent regulatory agencies in a timely manner: 
-  Withdrawal of EC approval will be reported to all EC and the pertinent regulatory 
agencies within 5 working days of receipt of withdrawal of approval.    
-  Withdraw of the pertinent regulatory agencies approval will be reported to trial sites 
and EC within 5 working days after receiving the notice of approval withdrawal. 
-  Current investigator list will be submitted to the pertinent regulatory agencies at 6‐
month intervals. 
-  Progress reports to the EC at least annually and to the pertinent regulatory agencies as 
required.  
-  A final written report is to be completed and submitted to the EC and the pertinent 
regulatory agencies within six months after completion or termination of the trial.  
-  Use of the devices without informed consent will be reported to regulatory authorities 
within 5 working days after notification of device use. 
-  Upon request by a reviewing EC or the pertinent regulatory agencies, Edwards will 
provide current information about any aspect of the trial. 
13.6 PUBLICATION POLICY 
The publication of trial results will require prior approval and consent from the trial sponsor. 
Any analyses generated from the trial database for a manuscript will require review and 
approval by the trial sponsor prior to publication submission. 

Edwards Pericardial Aortic Bioprosthesis, Model 11000
   
Clinical Trial Number: 2010‐03 
 
Revision C: 8 MAY 2012 
Confidential
Page 34of 42
 
14  REFERENCES 
1. Rosenhek R, Binder R, Porenta G et al. Predictors of outcome in severe asymptomatic aortic 
stenosis. N Engl J Med 2000; 343(9): 611‐7.  
2. Horstkotte D, Loogen F. The natural history of aortic valve stenosis. Eur Heart J Supp E 1998; 57‐
64.  
3. Carpentier A. Cardiac valve surgery. The French Correction.  J Thorac Cardiovasc Surg 1983; 86: 
323‐37. 
4. Carpentier A. Carpentier's Reconstructive Valve Surgery. Maryland Heights: Saunders, 2010. 
5. Craver JM. Aortic valve debridement by ultrasonic surgical aspirator: A word of caution.  Ann 
Thorac Surg 1990; 49: 746‐52. 
6. Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle 
BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; American College 
of Cardiology/American Heart Association Task Force on Practice Guidelines. 2008 focused 
update incorporated into the 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). Endorsed by the Society of 
Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and 
Society of Thoracic Surgeons. J Am Coll Cardiol 2008; 52(13):e1‐142. 
 
15 APPENDICES 
Appendices could be updated independently from the Clinical Investigation Plan 
 

Edwards Pericardial Aortic Bioprosthesis, Model 11000 
Clinical Trial Number: 2010‐03 
 
Revision C: 8 MAY 2012 
Confidential
Page 35of 42
 
 
15.1 ADVERSE EVENT (CODES AND DEFINITIONS) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 1 OF 15 
AE.1   BLOOD AND LYMPHATIC  (INCLUDING
 ALL BLEEDING COMPLICATIONS) 
AE101 
ANEMIA – NON-
BLEEDING RELATED 
A  CONDITION  IN  WHICH  RED  BLOOD  CELL  COUNT  AND/
OR  HEMOGLOBIN  ARE  LESS  THAN  NORMAL  DUE  TO  LACK  OF 
PRODUCTION OF RED BLOOD CELLS,
 AND THAT REQUIRES TREATMENT OR TRANSFUSION. 
AE102 
ANEMIA – BLEEDING RELATED -
 MAJOR 
A CONDITION IN WHICH RED BLOOD CELL COUNT AND/
OR HEMOGLOBIN ARE LESS THAN NORMAL DUE TO BLOOD LOSS,
 
AND THAT REQUIRES TREATMENT OR TRANSFUSION. 
AE103 
ANEMIA – BLEEDING RELATED -
 MINOR 
A CONDITION IN WHICH RED BLOOD CELL COUNT AND/
OR HEMOGLOBIN ARE LESS THAN NORMAL DUE TO BLOOD LOSS,
 
AND THAT REQUIRES TREATMENT OR TRANSFUSION. 
AE104 
BLEEDING -
 CARDIOVASCULAR -
 MAJOR 
ANY  EPISODE  OF  MAJOR  
INTERNAL  OR EXTERNAL  BLEEDING  THAT  CAUSES  DEATH,
  HOSPITALIZATION,
  OR  PERMANENT 
INJURY (
E.
G.,
  VISION  LOSS)
  OR  NECESSITATES  TRANSFUSION.
  MAJOR  BLEEDING  UNEXPECTEDLY  ASSOCIATED  WITH 
MINOR TRAUMA SHOULD BE REPORTED AS A BLEEDING EVENT,
 BUT BLEEDING ASSOCIATED WITH MAJOR TRAUMA OR A 
MAJOR  OPERATION (
INCLUDING  THE  INDEX  PROCEDURE)
  SHOULD  NOT.
    THE  LOCATION  OF  THE  BLEEDING 
(
GASTROINTESTINAL,
 GENITOURINARY,
 ETC.)
 MUST BE REPORTED.
  FOR EACH REPORTED BLEEDING EVENT,
 INDICATE IF 
SUBJECT IS TAKING ANTICOAGULANTS OR ANTI-
PLATELET AGENTS. 
AE105 
BLEEDING -
 CARDIOVASCULAR -
 MINOR 
" 
AE106 
BLEEDING -
 GENITOURINARY -
 MAJOR 
" 
AE107 
BLEEDING -
 GENITOURINARY -
 MINOR 
" 
AE108 
BLEEDING -
 GASTROINTESTINAL UPPER -
MAJOR 
" 
AE109 
BLEEDING -
 GASTROINTESTINAL UPPER -
MINOR 
" 
AE110 
BLEEDING -
 GASTROINTESTINAL LOWER -
MAJOR 
" 
AE111 
BLEEDING -
 GASTROINTESTINAL LOWER -
MINOR 
" 
AE112 
BLEEDING -
 MUSCULOSKELETAL/
DERMATOLOGICAL -
MAJOR    "
   (
E.
G.
 ECCHYMOSIS) 
AE113 
BLEEDING -
 MUSCULOSKELETAL/
DERMATOLOGICAL -
MINOR    "
   (
E.
G.
 ECCHYMOSIS) 
AE114 
BLEEDING -
 NEUROLOGICAL -
 MAJOR  
"
   (
E.
G.
 CEREBRAL VASCULAR ACCIDENT) 
AE115 
BLEEDING -
 NEUROLOGICAL -
 MINOR  
"
   (
E.
G.
 CEREBRAL VASCULAR ACCIDENT) 
AE116 
BLEEDING -
 PERIPHERAL VASCULAR -
MAJOR  
"
   (
E.
G.
 NOSEBLEEDS;
 HEMATOMAS) 
AE117 
BLEEDING -
 PERIPHERAL VASCULAR -
 MINOR  
"
   (
E.
G.
 NOSEBLEEDS;
 HEMATOMAS) 
AE118 
BLEEDING -
 PULMONARY/
RESPIRATORY -
 MAJOR  
"
   (
E.
G.
 HEMOTHORAX) 
AE119 
BLEEDING -
 PULMONARY/
RESPIRATORY MINOR  
"
   (
E.
G.
 HEMOTHORAX) 
AE120 
BLOOD SEPSIS 
POSITIVE BLOOD CULTURE AND CLINICAL EVIDENCE OF INFECTION (
E.
G.
 FEVER,
 ELEVATED WBC COUNT,
 HYPOTENSION,
 
END ORGAN DYSFUNCTION)
 EVENT MUST BE CONFIRMED BY 2 CONSECUTIVE POSITIVE BLOOD CULTURES,
 EXPLANT OR 
AUTOPSY.
  

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 2 OF 15 
AE.1   BLOOD AND LYMPHATIC  (INCLUDING
 ALL BLEEDING COMPLICATIONS) (
CONTINUED) 
AE122 
HEMOLYSIS WITHOUT PARAVALVULAR LEAK 
PLASMA -
FREE HEMOGLOBIN > 40 MG/
DL ON TWO CONSECUTIVE MEASUREMENTS WITHIN 48 HOURS;
 OR CLINICAL 
DIAGNOSIS OF HEMOLYSIS EVIDENCED BY LABORATORY TESTING SUCH AS SERUM HEMOGLOBIN,
 HEMATOCRIT,
 AND/
OR 
PLASMA-
FREE HEMOGLOBIN (
NOT IMMUNOLOGICALLY BASED) 
AE123 
DISSEMINATED INTRAVASCULAR COAGULATION (
DIC) 
DIFFUSE,
 NONSURGICAL,
 MICROVASCULAR HEMORRHAGE AND/
OR THROMBOSES. 
AE124 
THROMBOCYTOPENIA – HEPARIN INDUCED (
HIT) 
THROMBOCYTOPENIA (<150,000
 PER CUBIC MILLIMETER),
 OR A RELATIVE DECREASE OF 50 PERCENT OR MORE FROM 
BASELINE,
 OR NEW THROMBOSIS IN A SUBJECT RECEIVING HEPARIN OR LMWH;
 CONFIRMED BY SEROLOGIC TESTING FOR 
PF4–HEPARIN ANTIBODIES. 
AE125 
THROMBOCYTOPENIA – NON-
HEPARIN INDUCED  
THROMBOCYTOPENIA (<150,000
 PER CUBIC MILLIMETER),
 OR A RELATIVE DECREASE OF 50 PERCENT OR MORE FROM 
BASELINE,
  ACCOMPANIED  BY  A  LOW  INDEX  OF  SUSPICION  FOR  HIT (
I.
E.,
  NOT  ASSOCIATED  WITH  HEPARIN  USE,
  THE 
PRESENCE  OF  OTHER  CAUSES  OF  THROMBOCYTOPENIA,
  SUCH  AS  DRUGS  OTHER  THAN  HEPARIN,
  DIC  OR  OTHER 
CONSUMPTIVE PROCESSES,
 POST-
TRANSFUSION PURPURA). 
AE126 
BLOOD/
 LYMPHATIC -
 OTHER 
OTHER BLOOD OR LYMPHATIC EVENT THAT DOES NOT FIT IN ONE OF THE OTHER “
BLOOD”
 CATEGORIES THAT REQUIRES 
HOSPITALIZATION OR MEDICAL INTERVENTION. 
AE.2   CARDIOVASCULAR -
 ARRHYTHMIA 
AE158 
ARRHYTHMIA -
 PERMANENT ATRIAL FIBRILLATION 
AN  ABNORMAL  HEARTBEAT  
IN  WHICH  THE  HEART  RHYTHM  
IS  FAST  AND  
IRREGULARLY  
IRREGULAR.
  EVENT  SHOULD  BE 
DOCUMENTED  AND  CONFIRMED BY  ECG  TEST  RESULTS.
    AF  IS  CONSIDERED  PERMANENT  WHEN  IT  HAS  PERSISTED 
BEYOND 1 YEAR AND ATTEMPTS AT CARDIOVERSION HAVE FAILED OR COULD NOT BE ATTEMPTED. 
AE149 
ARRHYTHMIA -
 PAROXYSMAL ATRIAL FIBRILLATION (
PAF) 
 AN  ABNORMAL  HEARTBEAT  
IN WHICH  THE  HEART  RHYTHM  
IS  FAST  AND  
IRREGULARLY  
IRREGULAR.
  EVENT  SHOULD  BE 
DOCUMENTED  AND  CONFIRMED  BY  ECG  TEST  RESULTS.
    AF  IS  CONSIDERED  PAROXYSMAL  WHEN  EPISODES  OF  AF 
TERMINATE SPONTANEOUSLY WITHIN 7 DAYS (
MOST EPISODES LAST LESS THAN 24 HOURS) 
AE157 
ARRHYTHMIA -
 PERSISTENT ATRIAL FIBRILLATION 
AN  ABNORMAL  HEARTBEAT  
IN  WHICH  THE  HEART  RHYTHM  
IS  FAST  AND  
IRREGULARLY  
IRREGULAR.
  EVENT  SHOULD  BE 
DOCUMENTED AND CONFIRMED BY ECG TEST RESULTS .
 AF IS CONSIDERED PERSISTENT  WHEN EPISODES OF AF LAST 
MORE THAN 7 DAYS AND MAY REQUIRE EITHER PHARMACOLOGIC OR ELECTRICAL INTERVENTION TO TERMINATE  
AE141 
ARRHYTHMIA -
 ATRIAL FLUTTER 
WELL  ORGANIZED  BUT  OVERLY  RAPID  CONTRACTIONS  OF  HEART  ATRIUM (
USUALLY  AT  A  RATE  OF 250-350 
CONTRACTIONS PER MINUTE).
 EVENT SHOULD BE DOCUMENTED AND CONFIRMED BY ECG TEST RESULTS. 
AE142 
ARRHYTHMIA -
 AV BLOCK -
 1ST DEGREE 
AV BLOCK I:
  A CONDUCTION DISORDER OF NERVOUS IMPULSE AT THE LEVEL OF THE ATRIOVENTRICULAR JUNCTION,
 I.
E.
 
BETWEEN ATRIUM AND VENTRICLE. 
AE143 
ARRHYTHMIA -
 AV BLOCK -
 2ND DEGREE 
"
    AV  BLOCK  II:
  THERE  ARE  TWO  TYPES:  MOBITZ  I    PROGRESSIVE  PROLONGATION  OF  PR  INTERVAL  WITH  DROPPED 
BEATS (
THE  PR  
INTERVAL  GETS  LONGER  AND  LONGER;
  FINALLY  ONE  BEAT  DROPS)
  
  MOBITZ  
II  PR  
INTERVAL  REMAINS 
UNCHANGED PRIOR TO THE P-
WAVE WHICH SUDDENLY FAILS TO CONDUCT TO THE VENTRICLES; 
AE144 
ARRHYTHMIA -
 AV BLOCK -
 3RD DEGREE 
"
  
  AV  BLOCK  
III:
  ,
  NO  P-
WAVES  CONDUCT  TO  THE  VENTRICLE  AND  AV  DISSOCIATION  
IS  COMPLETE.
  
  ANY  LEVEL  OF  AV 
BLOCK EVENT SHOULD BE DOCUMENTED AND CONFIRMED BY ECG TEST RESULTS. 

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 3 OF 15 
AE145 
ARRHYTHMIA -
 BUNDLE BRANCH BLOCK -
 LEFT 
BUNDLE BRANCH BLOCK IS AN INTRAVENTRICULAR CONDUCTION DEFECT (
IVCD)
 THAT DISRUPTS THE NORMAL FLOW OF 
ELECTRICAL IMPULSES THAT RESULT IN A NORMAL HEART BEAT.
   QRS DURATION OF GREATER THAN 110 MILLISECONDS 
IS A DIAGNOSTIC INDICATION OF BBB.
 EVENT SHOULD BE DOCUMENTED AND CONFIRMED BY ECG TEST RESULTS. 
AE.2   CARDIOVASCULAR – ARRHYTHMIA (
CONTINUED) 
AE146 
ARRHYTHMIA -
 BUNDLE BRANCH BLOCK -
 RIGHT 
" 
AE147 
ARRHYTHMIA -
 SUPRAVENTRICULAR TACHYCARDIA (
SVT) 
SUSTAINED TACHYARRHYTHMIA IN WHICH THE QRS APPEARS NORMAL AND HAS DURATION OF < 120 MSEC.
  EVENT 
SHOULD BE DOCUMENTED AND CONFIRMED BY ECG TEST RESULTS. 
AE148 
ARRHYTHMIA -
 PAROXYSMAL ATRIAL TACHYCARDIA (
PAT) 
 A RAPID HEART RHYTHM ORIGINATING ABOVE THE VENTRICULAR TISSUE DUE TO AV NODAL REENTRANT TACHYCARDIA.
 
EVENT SHOULD BE DOCUMENTED AND CONFIRMED BY ECG TEST RESULTS. 
AE150 
ARRHYTHMIA -
 VENTRICULAR FIBRILLATION 
A RAPID IRREGULAR VENTRICULAR RHYTHM DUE TO MULTIPLE REENTRANT ACTIVITIES ASSOCIATED WITH ESSENTIALLY 
ZERO CARDIAC OUTPUT.
 EVENT SHOULD BE DOCUMENTED AND CONFIRMED BY ECG TEST RESULTS. 
AE151 
ARRHYTHMIA -
 TACHYCARDIA -
 VENTRICULAR 
AN ABNORMALLY FAST HEART RATE (
TYPICALLY DEFINED AS >100 BPM IN ADULTS)
 WHICH MAY REQUIRE IMPLANT OF A 
PACEMAKER TO MAINTAIN A NORMAL HEART RATE.
  EVENT SHOULD BE DOCUMENTED AND CONFIRMED BY ECG TEST 
RESULTS.
 VENTRICULAR TACHYCARDIA:
  DEFINED AS A REGULAR HEART RHYTHM ORIGINATING FROM THE VENTRICLE 
WITH A FREQUENCY OF 160 TO 200 BEATS PER MINUTE.
 EVENT SHOULD BE DOCUMENTED AND CONFIRMED BY ECG 
TEST RESULTS. 
AE152 
ARRHYTHMIA -
 TACHYCARDIA -
 NON-
VENTRICULAR 
ASSUMED " 
AE153 
ARRHYTHMIA -
 BRADYCARDIA 
AN ABNORMALLY SLOW HEART RATE (
TYPICALLY DEFINED AS <60 BPM IN ADULTS)
   EVENT SHOULD BE DOCUMENTED 
AND CONFIRMED BY ECG TEST RESULTS. 
AE154 
ARRHYTHMIA -
 TACHY-
BRADYCARDIA 
A VARIANT OF SICK SINUS SYNDROME IN WHICH SLOW ARRHYTHMIAS AND FAST ARRHYTHMIAS ALTERNATE.
 EVENT 
SHOULD BE DOCUMENTED AND CONFIRMED BY ECG TEST RESULTS. 
AE155 
ARRHYTHMIA -
 PACEMAKER/
ICD MALFUNCTION 
PACEMAKER/
ICD DOES NOT FUNCTION AS INTENDED. 
AE156 
ARRHYTHMIA -
 OTHER 
ARRHYTHMIA THAT IS NOT COVERED BY ANY OF THE DEFINITIONS ABOVE.
  PLEASE SPECIFY 
AE.3   CARDIOVASCULAR  -
 REGURGITATION 
 
IF  THE  VALVE  INVOLVED  IS  THE  STUDY  VALVE,
  THEN  THIS  DEFINITION  SHOULD  BE  USED,
 BUT  THE  EVENT  SHOULD  BE  REPORTED  AS  STRUCTURAL  OR  NON-
STRUCTURAL  VALVE 
DYSFUNCTION (
AS APPROPRIATE)
   REGURGITATION,
 AORTIC:
  ALSO KNOWN AS AORTIC INSUFFICIENCY AND INCOMPETENCE OF THE AORTIC VALVE,
 IN WHICH A PORTION OF THE LEFT 
VENTRICULAR  FORWARD  STROKE  VOLUME  RETURNS  TO  THE  CHAMBER  DURING  DIASTOLE.
  
  THIS CATEGORY  DOES NOT  
INCLUDE  PARAVALVULAR LEAK,
 WHICH  SHOULD  BE  CAPTURED 
UNDER  NON-
STRUCTURAL  VALVE  DYSFUNCTION.
  
  REGURGITATION,
  CENTRAL:
  
  OCCURS  WHEN  THE  VALVE  LEAFLETS  DO  NOT  COMPLETELY  CLOSE  AND  ALLOW  SOME  BLOOD  TO  LEAK 
BACK  INTO  THE  HEART.
    REGURGITATION,
  
INDETERMINATE:
    OCCURS  WHEN  BLOOD  LEAKS  BACK  INTO  THE  HEART  AND CANNOT  BE  CATEGORIZED  BY  LOCATION  AND  OR  SEVERITY.
 
REGURGITATION,
 MITRAL:
  ALSO KNOWN AS MITRAL INCOMPETENCE AND MITRAL INSUFFICIENCY IN WHICH THE BLOOD FLOWS BACKWARDS THROUGH THE MITRAL VALVE EACH TIME THE 
LEFT  VENTRICLE  CONTRACTS.
  DIAGNOSED  BY  AUSCULTATION (
MURMUR)
  OR  ECHOCARDIOGRAPHY.
  
  REGURGITATION,
  TRICUSPID:
  
  
INSUFFICIENCY  OF  THE TRICUSPID  VALVE  CAUSING 
BLOOD FLOW FROM THE RIGHT VENTRICLE TO THE RIGHT ATRIUM DURING SYSTOLE.
    
AE160 
REGURGITATION -
 AORTIC-
CENTRAL/
TRANSVALVULAR-+1 
TRIVIAL/
TRACE 
AE161 
REGURGITATION -
 AORTIC-
CENTRAL/
TRANSVALVULAR-+2 
MILD 

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 4 OF 15 
AE162 
REGURGITATION -
 AORTIC-
CENTRAL/
TRANSVALVULAR-+3 
MODERATE 
AE163 
REGURGITATION -
 AORTIC-
CENTRAL/
TRANSVALVULAR-+4 
SEVERE   
AE168 
REGURGITATION -
 AORTIC-
INDETERMINATE-+1 
TRIVIAL/
TRACE 
AE.3   CARDIOVASCULAR  -
 REGURGITATION (
CONTINUED) 
AE169 
REGURGITATION -
 AORTIC-
INDETERMINATE-+2 
MILD 
AE170 
REGURGITATION -
 AORTIC-
INDETERMINATE-+3 
MODERATE 
AE171 
REGURGITATION -
 AORTIC-
INDETERMINATE-+4 
SEVERE   
AE172 
REGURGITATION -
 MITRAL-
CENTRAL/
TRANSVALVULAR-+1 
TRIVIAL/
TRACE 
AE173 
REGURGITATION -
 MITRAL-
CENTRAL/
TRANSVALVULAR-+2 
MILD 
AE174 
REGURGITATION -
 MITRAL-
CENTRAL/
TRANSVALVULAR-+3 
MODERATE 
AE175 
REGURGITATION -
 MITRAL-
CENTRAL/
TRANSVALVULAR-+4 
SEVERE   
AE180 
REGURGITATION -
 MITRAL-
INDETERMINATE-+1 
TRIVIAL/
TRACE 
AE181 
REGURGITATION -
 MITRAL-
INDETERMINATE-+2 
MILD 
AE182 
REGURGITATION -
 MITRAL-
INDETERMINATE-+3 
MODERATE 
AE183 
REGURGITATION -
 MITRAL-
INDETERMINATE-+4 
SEVERE   
AE190 
REGURGITATION -
 PULMONARY-
CENTRAL/
TRANSVALVULAR-+1 TRIVIAL/
TRACE 
AE191 
REGURGITATION -
 PULMONARY-
CENTRAL/
TRANSVALVULAR-+2 MILD 
AE192 
REGURGITATION -
 PULMONARY-
CENTRAL/
TRANSVALVULAR-+3 MODERATE 
AE193 
REGURGITATION -
 PULMONARY-
CENTRAL/
TRANSVALVULAR-+4 SEVERE   
AE198 
REGURGITATION -
 PULMONARY-
INDETERMINATE-+1 
TRIVIAL/
TRACE 
AE199 
REGURGITATION -
 PULMONARY-
INDETERMINATE-+2 
MILD 
AE200 
REGURGITATION -
 PULMONARY-
INDETERMINATE-+3 
MODERATE 
AE201 
REGURGITATION -
 PULMONARY-
INDETERMINATE-+4 
SEVERE   
AE202 
REGURGITATION -
 TRICUSPID-
CENTRAL/
TRANSVALVULAR-+1 
TRIVIAL/
TRACE 
AE203 
REGURGITATION -
 TRICUSPID-
CENTRAL/
TRANSVALVULAR-+2 
MILD 
AE204 
REGURGITATION -
 TRICUSPID-
CENTRAL/
TRANSVALVULAR-+3 
MODERATE 
AE205 
REGURGITATION -
 TRICUSPID-
CENTRAL/
TRANSVALVULAR-+4 
SEVERE   

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 5 OF 15 
AE210 
REGURGITATION -
 TRICUSPID-
INDETERMINATE-+1 
TRIVIAL/
TRACE 
AE211 
REGURGITATION -
 TRICUSPID-
INDETERMINATE-+2 
MILD 
AE212 
REGURGITATION -
 TRICUSPID-
INDETERMINATE-+3 
MODERATE 
AE213 
REGURGITATION -
 TRICUSPID-
INDETERMINATE-+4 
SEVERE   
AE.5    CARDIOVASCULAR  -
 STENOSIS 
*IF THE VALVE INVOLVED IS THE STUDY VALVE,
 THEN THIS DEFINITION SHOULD BE USED,
 BUT THE EVENT SHOULD BE 
REPORTED AS STRUCTURAL OR NON-
STRUCTURAL VALVE DYSFUNCTION (
AS APPROPRIATE)
   
AE220* 
STENOSIS -
 AORTIC -
 MILD 
AORTIC:
    FLOW  OBSTRUCTION  OF  THE  AORTIC  VALVE  DUE  TO  RESTRICTED  LEAFLET  OPENING.
    THE  SEVERITY  IS 
CATEGORIZED  AS:
  MILD -
  JET  VELOCITY (
M/
S)
 <3.0;  MEAN  GRADIENT (
MMHG)
 <25;  VALVE  AREA (
CM2) 
>1.5.MODERATE -
  JET  VELOCITY (
M/
S)
 3.0-4.0;  MEAN  GRADIENT (
MMHG)
 25-40;  VALVE  AREA (
CM2) 1.0- 1.5.  OR 
SEVERE -
  JET  VELOCITY (
M/
S)
 >4.0;  MEAN  GRADIENT (
MMHG)
 >40;  VALVE  AREA (
CM2) <1.0;  VALVE  AREA 
INDEX<0.6.   MITRAL:
  MITRAL STENOSIS (
MS)
 REFERS TO NARROWING OF THE MITRAL VALVE ORIFICE,
 RESULTING IN 
IMPEDANCE OF FILLING OF THE LEFT VENTRICLE IN DIASTOLE.
 THE SEVERITY OF MS IS CATEGORIZED AS:
 MILD -
 MEAN 
GRADIENT (
MM  HG)
 < 5,  PULMONARY  ARTERY  SYSTOLIC  PRESSURE (
MM  HG)
 < 30,  VALVE  AREA (
CM2) >1.5. 
MODERATE -
  MEAN  GRADIENT (
MM  HG)
 5-10,  PULMONARY  ARTERY  SYSTOLIC  PRESSURE (
MM  HG)
 30-50,  VALVE 
AREA (
CM2) 1.0-1.5. SEVERE -
 MEAN GRADIENT (
MM HG)
 > 10, PULMONARY ARTERY SYSTOLIC PRESSURE (
MM HG)>
 
50,  VALVE  AREA (
CM2) <1.0.    TRICUSPID:
    A  NARROWING  OF  THE  TRICUSPID  VALVE  OPENING  THAT  INCREASES 
RESISTANCE  TO BLOOD  FLOW  FROM  THE  RIGHT  ATRIUM  TO  THE  RIGHT  VENTRICLE.
 SEVERE TRICUSPID STENOSIS IS 
DEFINED AS A VALVE AREA LESS THAN 1.0 CM2. 
AE221* 
STENOSIS -
 AORTIC -
 MODERATE 
" 
AE222* 
STENOSIS -
 AORTIC -
 SEVERE 
" 
AE223 
STENOSIS -
 MITRAL-
 MILD 
" 
AE224 
STENOSIS -
 MITRAL -
 MODERATE 
" 
AE225 
STENOSIS -
 MITRAL -
 SEVERE 
" 
AE226 
STENOSIS -
 PULMONARY-
 MILD 
" 
AE227 
STENOSIS -
 PULMONARY -
 MODERATE 
" 
AE228 
STENOSIS -
 PULMONARY -
 SEVERE 
" 
AE229 
STENOSIS -
 TRICUSPID-
 MILD 
" 
AE230 
STENOSIS -
 TRICUSPID-
 MODERATE 
" 
AE231 
STENOSIS -
 TRICUSPID -
 SEVERE 
" 
 
 

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 6 OF 15 
AE.6 
CARDIOVASCULAR  -
 THROMBOEMBOLIC 
EVENT/VALVE THROMBOSIS 
ANY EMBOLIC EVENT THAT OCCURS IN THE ABSENCE OF INFECTION AFTER THE IMMEDIATE PERIOPERATIVE PERIOD 
AND MAY BE MANIFESTED BY A NEUROLOGIC EVENT OR A NON-
CEREBRAL EMBOLIC EVENT.
  EMBOLI CONSISTING OF 
NON-
THROMBOTIC MATERIAL (
E.
G.,
 ATHEROSCLEROSIS,
 MYXOMA)
 ARE NOT COUNTED. 
AE250 
THROMBOEMBOLIC EVENT – STROKE 
INCLUDES ANY CENTRAL,
 NEW NEUROLOGIC DEFICIT,
 WHETHER TEMPORARY OR PERMANENT AND WHETHER FOCAL 
OR  GLOBAL,
  THAT  OCCURS  AFTER  THE  SUBJECT  EMERGES  FROM  ANESTHESIA.
    POSTOPERATIVE  NEUROLOGIC 
SYMPTOMS  THAT  MIMIC  THOSE  OF  A  PREOPERATIVELY  DOCUMENTED  NEUROLOGIC  EVENT  AND  THAT  ARE 
CONFIRMED  RADIOGRAPHICALLY  TO  BE  CONSISTENT  WITH  THE  FORMER  EVENT  ARE  NOT  COUNTED.
  CENTRAL 
NEUROLOGIC EVENTS THAT ARE CLEARLY RELATED TO AORTIC,
 INTERNAL CAROTID ARTERY,
 OR VERTEBRAL ARTERY 
DISEASE ARE ALSO NOT COUNTED.
 PSYCHOMOTOR DEFICITS FOUND BY SPECIALIZED TESTING ARE NOT CONSIDERED 
NEUROLOGIC  EVENTS  RELATED  TO  OPERATED  VALVES.
  SUBJECTS  WHO  DO  NOT  AWAKEN  OR  WHO  AWAKEN  AFTER 
OPERATION WITH A NEW STROKE ARE NOT CONSIDERED TO HAVE SUSTAINED VALVE-
RELATED NEUROLOGIC EVENTS.
 
STROKE:
  
  A  PROLONGED (>72
  HOURS)
  OR  PERMANENT  NEUROLOGIC  DEFICIT  THAT  
IS  USUALLY  ASSOCIATED  WITH 
ABNORMAL RESULTS OF MRI OR CT SCANS.
 SUBJECTS WITH MINIMAL,
 ATYPICAL,
 OR PROTEAN SYMPTOMS THAT LEAD 
TO RADIOGRAPHIC IMAGING DEMONSTRATING AN ACUTE ISCHEMIC EVENT ARE CONSIDERED TO HAVE SUSTAINED A 
STROKE.
  TIA:
 CHARACTERIZED BY FULLY REVERSIBLE SYMPTOMS OF SHORT DURATION.
 IF RADIOGRAPHIC IMAGING 
DEMONSTRATES  AN  ACUTE  CENTRAL  NEUROLOGIC  LESION,
  HOWEVER,
  SUCH  SUBJECTS  ARE  RECLASSIFIED  AS 
HAVING SUSTAINED A STROKE. 
AE255 
THROMBOEMBOLIC EVENT – TRANSIENT ISCHEMIC ATTACK 
(
TIA)
  
INCLUDES ANY CENTRAL,
 NEW NEUROLOGIC DEFICIT,
 WHETHER TEMPORARY OR PERMANENT AND WHETHER FOCAL 
OR  GLOBAL,
  THAT  OCCURS  AFTER  THE  SUBJECT  EMERGES  FROM  ANESTHESIA.
    POSTOPERATIVE  NEUROLOGIC 
SYMPTOMS  THAT  MIMIC  THOSE  OF  A  PREOPERATIVELY  DOCUMENTED  NEUROLOGIC  EVENT  AND  THAT  ARE 
CONFIRMED  RADIOGRAPHICALLY  TO  BE  CONSISTENT  WITH  THE  FORMER  EVENT  ARE  NOT  COUNTED.
  CENTRAL 
NEUROLOGIC EVENTS THAT ARE CLEARLY RELATED TO AORTIC,
 INTERNAL CAROTID ARTERY OR VERTEBRAL ARTERY 
DISEASE ARE ALSO NOT COUNTED.
 PSYCHOMOTOR DEFICITS FOUND BY SPECIALIZED TESTING ARE NOT CONSIDERED 
NEUROLOGIC  EVENTS  RELATED  TO  OPERATED  VALVES.
  SUBJECTS  WHO  DO  NOT  AWAKEN  OR  WHO  AWAKEN  AFTER 
OPERATION WITH A NEW STROKE ARE NOT CONSIDERED TO HAVE SUSTAINED VALVE-
RELATED NEUROLOGIC EVENTS.
 
STROKE:
  
  A  PROLONGED (>72
  HOURS)
  OR  PERMANENT  NEUROLOGIC  DEFICIT  THAT  
IS  USUALLY  ASSOCIATED  WITH 
ABNORMAL RESULTS OF MRI OR CT SCANS.
 SUBJECTS WITH MINIMAL,
 ATYPICAL,
 OR PROTEAN SYMPTOMS THAT LEAD 
TO RADIOGRAPHIC IMAGING DEMONSTRATING AN ACUTE ISCHEMIC EVENT ARE CONSIDERED TO HAVE SUSTAINED A 
STROKE.
  TIA:
 CHARACTERIZED BY FULLY REVERSIBLE SYMPTOMS OF SHORT DURATION.
 IF RADIOGRAPHIC IMAGING 
DEMONSTRATES  AN  ACUTE  CENTRAL  NEUROLOGIC  LESION,
  HOWEVER,
  SUCH  SUBJECTS  ARE  RECLASSIFIED  AS 
HAVING SUSTAINED A STROKE. 
AE256 
THROMBOEMBOLIC EVENT -
 OTHER -
 PERIPHERAL 
 NO PARESIS 
A  PERIPHERAL  EMBOLIC  EVENT  IS  AN  OPERATIVE,
  AUTOPSY,
  OR  CLINICALLY  DOCUMENTED  EMBOLUS  THAT 
PRODUCES  SYMPTOMS  FROM  COMPLETE  OR PARTIAL  OBSTRUCTION  OF  A  PERIPHERAL (
NON-
CEREBRAL)
  ARTERY.
 
LOCATION SHOULD BE REPORTED.
  REPORT UNDER PULMONARY EMBOLISM IF EVENT OCCURS IN THE LUNG.
   
AE257 
THROMBOEMBOLIC EVENT -
 OTHER – PERIPHERAL 
"
 HEMIPARESIS 
AE258 
THROMBOEMBOLIC EVENT -
 OTHER -
 PERIPHERAL  
"
 FULL PARESIS 
AE259 
THROMBOEMBOLIC EVENT -
 OTHER -
 CENTRAL  
"
 NO PARESIS 

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 7 OF 15 
AE260 
THROMBOEMBOLIC EVENT -
 OTHER – CENTRAL 
"
 HEMIPARESIS 
AE.6    CARDIOVASCULAR  -
 THROMBOEMBOLIC EVENT/VALVE THROMBOSIS (
CONTINUED) 
AE261 
THROMBOEMBOLIC EVENT -
 OTHER -
 CENTRAL 
"
 FULL PARESIS 
AE262 
VALVE THROMBOSIS -
 AORTIC 
ANY THROMBUS NOT CAUSED BY INFECTION ATTACHED TO OR NEAR AN OPERATED VALVE THAT OCCLUDES PART OF 
THE BLOOD FLOW PATH,
 INTERFERES WITH VALVE FUNCTION,
 OR IS SUFFICIENTLY LARGE TO WARRANT TREATMENT.
 
VALVE THROMBUS FOUND AT AUTOPSY IN A SUBJECT WHOSE CAUSE OF DEATH WAS NOT VALVE RELATED OR FOUND 
AT OPERATION FOR AN UNRELATED INDICATION SHOULD ALSO BE COUNTED. 
AE263 
VALVE THROMBOSIS -
 MITRAL 
" 
AE264 
VALVE THROMBOSIS -
 PULMONARY 
" 
AE265 
VALVE THROMBOSIS -
 TRICUSPID 
" 
AE.7    CARDIOVASCULAR  -
 MISC 
AE270 
ANGINA,
 STABLE 
CHEST PAIN,
 TIGHT OR HEAVY FEELING IN THE CHEST,
 OR DISCOMFORT WHICH SPREADS FROM THE CHEST TO THE 
ARM,
 BACK,
 NECK,
 JAW,
 OR STOMACH,
 NUMBNESS OR TINGLING IN THE SHOULDERS,
 ARMS OR WRISTS,
 SHORTNESS 
OF BREATH,
 AND NAUSEA RELIEVED BY REST OR NITROGLYCERINE AND/
OR CONFIRMED BY ECG.
  STABLE ANGINA IS 
ANGINA THAT IS CONTROLLED BY ORAL AND/
OR TRANSCUTANEOUS MEDICATION. 
AE271 
ANGINA,
 UNSTABLE 
UNSTABLE  ANGINA  IS  ANGINA,
  WHICH  NECESSITATES  THE  INITIATION,
  CONTINUATION  OR INCREASE  OF  ANGINA 
CONTROL THERAPIES THAT MAY INCLUDE:
 NITROGLYCERIN DRIP,
 HEPARIN DRIP,
 OR IABP PLACEMENT.
 THE TYPE OF 
ANGINA  MAY  
INCLUDE,
  BUT  
IS  NOT  LIMITED  TO:
  REST  ANGINA,
  NEW  ONSET  EXERTIONAL  ANGINA  OF  AT  LEAST  NEW 
YORK  HEART  ASSOCIATION (
NYHA)
  CLASS  
III  
IN  SEVERITY,
  RECENT  ACCELERATION IN  PATTERN  AND  
INCREASE  OF 
ONE NYHA CLASS TO AT LEAST NYHA CLASS III,
 VARIANT ANGINA,
 NON-
Q WAVE MYOCARDIAL INFARCTION,
 OR POST-
INFARCTION ANGINA. 
AE272 
ANNULAR DISSECTION 
DISSECTION  OF  THE  VALVULAR  ANNULUS  EXTENDING  
INTO  THE  AORTA.
  
  ANNULAR  DISSECTION  OCCURRING  WITHIN 
30  DAYS  OF  THE  
INDEX  PROCEDURE  WILL 
BE  CONSIDERED  VALVE  RELATED.
  
  SHOULD  BE  CONFIRMED  BY  
IMAGING,
 
OR DIRECT VISUAL INSPECTION. 
AE273 
AORTIC DISSECTION 
DISRUPTION  OF  THE  MEDIA  LAYER  OF  THE  AORTA  WITH BLEEDING  WITHIN  AND  ALONG  THE  WALL  OF  THE  AORTA.
  
AORTIC DISSECTION MAY OCCUR IN THE ASCENDING THORACIC AORTA (
TYPE A DISSECTION)
 OR IN THE DESCENDING 
THORACIC  AORTA (
TYPE  B  DISSECTION).
  DISSECTION  SHOULD  BE  CONFIRMED BY  IMAGING  OR  DIRECT  VISUAL 
INSPECTION. 
AE274 
ARTERIAL DISSECTION  
DISRUPTION OF THE MEDIA LAYER OF AN ARTERY OTHER THAN THE AORTA WITH BLEEDING WITHIN AND ALONG THE 
WALL OF THE VESSEL.
  SHOULD BE CONFIRMED BY IMAGING OR DIRECT VISUAL INSPECTION. 
AE275 
CARDIAC ARREST 
CARDIAC  ARREST  DOCUMENTED BY  ONE  OF  THE  FOLLOWING:
  VENTRICULAR  FIBRILLATION,
  RAPID  VENTRICULAR 
TACHYCARDIA WITH HEMODYNAMIC INSTABILITY,
 ASYSTOLE. 
AE276 
CARDIAC DECOMPENSATION 
AN  INABILITY  OF  THE  HEART  TO  MAINTAIN  ADEQUATE  CIRCULATION;
  IT  IS  MARKED  BY  DYSPNEA,
  VENOUS 
ENGORGEMENT,
 CYANOSIS AND EDEMA. 

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 8 OF 15 
AE277 
CARDIOGENIC SHOCK 
A CLINICAL STATE OF HYPOPERFUSION SUSTAINED FOR GREATER THAN 30 MINUTES,
 WITH EITHER SYSTOLIC BLOOD 
PRESSURE < 80  MM  HG,
  AND /
OR  CARDIAC  INDEX < 1.8  DESPITE  MAXIMAL  TREATMENT (
FLUIDS)
  OR  REQUIRING 
INTRAVENOUS INOTROPES AND/
OR PRESSOR AGENT OR AN INTRA-
AORTIC BALLOON PUMP (
IABP).
  
AE.7    CARDIOVASCULAR  -
 MISC (
CONTINUED) 
AE278 
CHORDAE TENDINEAE DAMAGE 
AE279 
CORONARY ARTERY OSTIAL OBSTRUCTION 
OBSTRUCTION  OF  THE  CORONARY  OSTIA.
    SHOULD  BE  CONFIRMED  BY  IMAGING  AND  THE  SOURCE  OF  THE 
OBSTRUCTION (
AORTIC VALVE,
 THROMBUS,
 ETC.
 SHOULD BE REPORTED. 
AE280 
ENDOCARDITIS 
ANY INFECTION INVOLVING THE STUDY VALVE.
 THE DIAGNOSIS OF OPERATED VALVULAR ENDOCARDITIS IS BASED ON 
ONE OF THE FOLLOWING CRITERIA:
 (1)
 REOPERATION WITH EVIDENCE OF ABSCESS,
 PARAVALVULAR LEAK,
 PUS,
 OR 
VEGETATION CONFIRMED AS SECONDARY TO INFECTION BY HISTOLOGIC OR MICROBIOLOGIC STUDIES;
 (2)
 AUTOPSY 
FINDINGS OF ABSCESS,
 PUS,
 OR VEGETATION INVOLVING A REPAIRED OR REPLACED VALVE;
 OR (3)
 IN THE ABSENCE 
OF REOPERATION OR AUTOPSY,
 MEETING OF THE DUKE CRITERIA FOR ENDOCARDITIS [4].
 MORBIDITIES ASSOCIATED 
WITH  ACTIVE  INFECTION,
  SUCH  AS  VALVE  THROMBOSIS,
  THROMBOTIC  EMBOLUS,
  BLEEDING  EVENT,
  OR 
PARAVALVULAR  LEAK,
  ARE  INCLUDED  UNDER  THIS  CATEGORY,
  BUT  NOT  COUNTED  IN  OTHER  CATEGORIES  OF 
MORBIDITY. 
AE281 
HEART FAILURE – ACUTE 
ACUTE HEART FAILURE DESCRIBES EXACERBATED OR DECOMPENSATED HEART FAILURE,
 REFERRING TO EPISODES 
IN WHICH A SUBJECT IS CHARACTERIZED AS HAVING A CHANGE IN HEART FAILURE SIGNS AND SYMPTOMS RESULTING 
IN A NEED FOR URGENT THERAPY OR HOSPITALIZATION. 
AE282 
HEART FAILURE – CHRONIC (
CHF) 
AN EVENT IN WHICH THE HEART FAILS TO MEET THE CIRCULATORY REQUIREMENTS OF THE BODY UNDER DIFFERING 
PHYSIOLOGICAL CIRCUMSTANCES,
 AND/
OR A STATE IN WHICH CARDIAC OUTPUT IS REDUCED RELATIVE TO THE 
DEMANDS OF THE BODY,
 ASSUMING THE EVIDENCE OF ADEQUATE VENOUS RETURN.
 EVENT IS CONFIRMED 
CLINICALLY OR BY DIAGNOSTIC TESTING. 
AE283 
HYPERTENSION – SYSTEMIC 
DEFINED AS BLOOD PRESSURE > 140 /90
 MM HG FOR SUBJECT WITHOUT DIABETES OR KIDNEY DISEASE;
 >130/80 
MMHG FOR SUBJECTS ON 2 OCCASIONS WITH DIABETES OR RENAL DISEASE.
 UNLESS DUE TO PRESENCE OF 
MEDICATION ,
 E.
G.
 BETA BLOCKERS FOR 10 YEARS 
AE284 
HYPERTENSION – PULMONARY 
MEAN PULMONARY ARTERY PRESSURE THAT IS GREATER THAN 25 MMHG AT REST AND/
OR GREATER THAN 30 
MMHG DURING EXERCISE CONFIRMED BY SWAN GANZ CATHETER OR DIAGNOSTIC PLACEMENT IN THE PULMONARY 
ARTERY BED AND CONDITION REQUIRES MEDICAL INTERVENTION TO RESOLVE OR TREAT THE CONDITION. 
AE285 
HYPOTENSION 
ABNORMALLY LOW BLOOD PRESSURE.
 FOR AN ADULT,
 HYPOTENSION IS DEFINED AS BLOOD PRESSURE LESS THAN 
90/50 MMHG. 
 
 

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 9 OF 15 
AE.7    CARDIOVASCULAR  -
 MISC (
CONTINUED) 
AE286 
MYOCARDIAL INFARCTION  
AN ACUTE MYOCARDIAL INFARCTION IS EVIDENCED BY ANY OF THE FOLLOWING: 
1. A RISE AND FALL OF CARDIAC BIOMARKERS (
PREFERABLY TROPONIN)
 WITH AT LEAST ONE OF THE VALUES IN THE 
ABNORMAL  RANGE (
CK ≥ 5X  ULN)
  TOGETHER  WITH  AT  LEAST  ONE  OF THE  FOLLOWING  MANIFESTATIONS  OF 
MYOCARDIAL ISCHEMIA:
  
A)
 ISCHEMIC SYMPTOMS;
  
B)
  ECG  CHANGES  INDICATIVE  OF  NEW  ISCHEMIA (
NEW  ST-
T  CHANGES,
  NEW  LEFT  BUNDLE  BRANCH  BLOCK,
  OR 
LOSS OF R WAVE VOLTAGE);
  
C)
 DEVELOPMENT OF PATHOLOGICAL Q WAVES IN 2 OR MORE CONTIGUOUS LEADS IN THE ECG (
OR EQUIVALENT 
FINDINGS  FOR  TRUE  POSTERIOR  MI);
 D.
  
IMAGING  EVIDENCE  OF  NEW  LOSS  OF  VIABLE  MYOCARDIUM  OR  NEW 
REGIONAL WALL MOTION ABNORMALITY. 
2.  DEVELOPMENT  OF  NEW  PATHOLOGICAL  Q  WAVES  IN 2  OR  MORE  CONTIGUOUS  LEADS  IN  THE  ECG,
  WITH  OR 
WITHOUT SYMPTOMS. 
3. IMAGING EVIDENCE OF A REGION WITH NEW LOSS OF VIABLE MYOCARDIUM AT REST IN THE ABSENCE OF A NON-
ISCHEMIC  CAUSE.
  THIS  CAN  BE  MANIFEST  AS:
 A.
  ECHOCARDIOGRAPHIC,
  CT,
  MR,
  VENTRICULOGRAPHIC  OR 
NUCLEAR  IMAGING  EVIDENCE  OF  LEFT  VENTRICULAR  THINNING  OR  SCARRING  AND FAILURE  TO  CONTRACT 
APPROPRIATELY (
I.
E.,
  HYPOKINESIS,
  AKINESIS,
  OR  DYSKINESIS);
  OR,
 B.
  FIXED (
NON-
REVERSIBLE)
  PERFUSION 
DEFECTS ON NUCLEAR RADIOISOTOPE IMAGING (
E.
G.,
 MIBI,
 THALLIUM). 
AE287 
MYOCARDITIS 
AN INFECTION OF THE HEART MUSCLE 
AE296 
PERFORATION -
 ATRIAL 
AN  ABNORMAL  HOLE  OR  OPENING  IN  THE  ATRIAL  WALL CAUSED  BY  A  DEVICE  CAUSING  PUNCTURE  THROUGH  THE 
WALL OR BY PRESSURE AGAINST A WEAKENED PORTION OF THE WALL. 
AE297 
PERFORATION -
 VENTRICULAR 
AN ABNORMAL HOLE OR OPENING IN THE VENTRICULAR WALL CAUSED BY  A  DEVICE  CAUSING  PUNCTURE  THROUGH 
THE WALL OR BY PRESSURE AGAINST A WEAKENED PORTION OF THE WALL. 
AE289 
PERFORATION -
 OTHER 
" 
AE290 
PERICARDIAL EFFUSION  -
 MAJOR 
EXCESS FLUID ACCUMULATION IN THE PERICARDIAL SPACE THAT INTERFERES WITH NORMAL HEART FUNCTION AND 
REQUIRES MEDICAL INTERVENTION TO RESOLVE.
  IT SHOULD BE CONFIRMED BY ECHOCARDIOGRAPHY OR CT.
  
AE291 
PERICARDIAL EFFUSION  -
 MINOR 
" 
AE292 
PERICARDIAL TAMPONADE -
 MAJOR 
ABNORMAL FLUID ACCUMULATION WITHIN THE PERICARDIAL SPACE THAT CAUSES HEMODYNAMIC COMPROMISE.
 THIS 
SHOULD  BE  DOCUMENTED  BY  EITHER:
 1.  ECHO  SHOWING  PERICARDIAL  FLUID  AND  SIGNS  OF  TAMPONADE  SUCH  AS 
RIGHT  HEART  COMPROMISE.
  2.  SYSTEMIC  HYPOTENSION  DUE  TO  PERICARDIAL  FLUID  COMPROMISING  CARDIAC 
FUNCTION. 
AE294 
PERICARDITIS 
AN INFLAMMATION OF THE PERICARDIUM (
THE FIBROUS SAC SURROUNDING THE HEART). 
AE295 
CARDIOVASCULAR -
 OTHER 
 
 

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 10 OF 15 
AE.8    GASTROINTESTINAL/HEPATIC 
AE350 
GASTROINTESTINAL – ESOPHAGEAL RUPTURE/
TEAR 
ANY EVIDENCE OF PUNCTURE/
DISSECTION/
PERFORATION,
 VARICES OR OTHER DAMAGE TO THE ESOPHAGUS 
REQUIRING INTERVENTION. 
AE351 
GASTROINTESTINAL – INFECTION 
SEVERE INFLAMMATION OF THE GASTROINTESTINAL TRACT INVOLVING BOTH THE STOMACH AND SMALL INTESTINE 
RESULTING IN ACUTE DIARRHEA AND VOMITING.
  SHOULD BE CONFIRMED BY CULTURE 
AE352 
GASTROINTESTINAL – OTHER 
OTHER GASTROINTESTINAL EVENT THAT DOES NOT FIT IN ONE OF THE OTHER GI/
HEPATIC CATEGORIES. 
AE353 
LIVER FAILURE -
 ACUTE 
A SYNDROME DEFINED BY THE OCCURRENCE OF ENCEPHALOPATHY,
 COAGULOPATHY AND JAUNDICE IN AN 
INDIVIDUAL WITH A PREVIOUSLY NORMAL LIVER.
  
AE354 
LIVER FAILURE -
 CHRONIC 
CHRONIC LIVER DISEASE CAUSES CAN BE ANY CONDITION THAT RESULTS IN THE GRADUAL DEGRADATION AND 
RENEWAL OF THE TISSUE CELLS WITH A BODY’
S LIVER.
 THIS PROCESS USUALLY RESULTS IN FIBROSIS OR CIRRHOSIS.
  
DIAGNOSIS MAY BE CONFIRMED BY ABNORMAL BLOOD ENZYMES AND/
OR BIOPSY  
AE355 
HEPATIC COMPLICATION -
 OTHER 
OTHER LIVER EVENTS THAT DO NOT MEET THE DEFINITION OF LIVER FAILURE (
E.
G.
 LIVER DYSFUNCTION)
 REQUIRING 
HOSPITALIZATION OR MEDICAL INTERVENTION. 
AE356 
PANCREATIC COMPLICATION (
PANCREAS) 
AN EVENT PERTAINING TO,
 CONNECTED WITH,
 OR AFFECTING THE PANCREAS REQUIRING HOSPITALIZATION OR 
MEDICAL INTERVENTION. 
AE357 
SPLENIC COMPLICATION (
SPLEEN) 
AN EVENT PERTAINING TO,
 CONNECTED WITH,
 OR AFFECTING THE SPLEEN REQUIRING HOSPITALIZATION OR MEDICAL 
INTERVENTION. 
AE358 
BILIARY (
GALLBLADDER) 
AN EVENT PERTAINING TO BILE OR TO THE GALLBLADDER AND BILE DUCTS,
 WHICH TRANSPORT BILE REQUIRING 
HOSPITALIZATION OR MEDICAL INTERVENTION. 
AE359 
ENDOCRINE COMPLICATIONS  
AN EVENT PERTAINING TO,
 CONNECTED WITH,
 OR AFFECTING THE ENDOCRINE SYSTEM REQUIRING HOSPITALIZATION 
OR MEDICAL INTERVENTION. 
AE360 
METABOLIC COMPLICATIONS 
AN EVENT PERTAINING TO,
 CONNECTED WITH,
 OR AFFECTING THE METABOLIC SYSTEM REQUIRING HOSPITALIZATION 
OR MEDICAL   INTERVENTION. 
AE.9    GENITOURINARY/RENAL 
AE370 
URINARY TRACT INFECTION (
UTI) 
INFECTION THAT AFFECTS ANY PART OF THE URINARY TRACT THAT REQUIRE HOSPITALIZATION OR MEDICAL 
INTERVENTION. 
AE371 
VAGINAL INFECTION 
INFECTIONS AFFECTING THE VAGINAL AREA THAT REQUIRE HOSPITALIZATION OR MEDICAL INTERVENTION. 
AE372 
GENITOURINARY – OTHER 
OTHER GENITOURINARY EVENT NOT PREVIOUSLY DESCRIBED REQUIRING HOSPITALIZATION OR MEDICAL 
INTERVENTION. 
AE373 
RENAL DYSFUNCTION 
AN ACUTE EVENT OR WORSENING OF RENAL FUNCTION POST-
OPERATIVELY (
INCREASE OF SERUM CREATININE TO < 
2.0 , AND < 2X MOST RECENT PREOPERATIVE CREATININE LEVEL)
 AND DOES NOT REQUIRE DIALYSIS. 

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 11 OF 15 
 
 

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 12 OF 15 
AE.9    GENITOURINARY/RENAL (
CONTINUED) 
AE374 
RENAL FAILURE – ACUTE  
AN ACUTE EVENT OR WORSENING OF RENAL FUNCTION RESULTING IN ONE OR MORE OF THE FOLLOWING:
 1) 
INCREASE OF SERUM CREATININE TO >2.0,  
AND 2X MOST RECENT PREOPERATIVE CREATININE LEVEL.
 2) A NEW 
REQUIREMENT FOR DIALYSIS POSTOPERATIVELY. 
AE375 
RENAL FAILURE – CHRONIC 
A PROGRESSIVE LOSS IN RENAL FUNCTION OVER A PERIOD OF MONTHS OR YEARS RESULTING IN A DIAGNOSIS OF 
STAGE 5 -
 CHRONIC KIDNEY DISEASE. 
AE376 
RENAL – OTHER 
OTHER EVENT THAT IS NOT RENAL FAILURE OR RENAL DYSFUNCTION THAT REQUIRES HOSPITALIZATION OR MEDICAL 
INTERVENTION. 
AE.10    PULMONARY/RESPIRATORY 
AE380 
ATELECTASIS 
COMPLETE OR PARTIAL COLLAPSE OF A PREVIOUSLY INFLATED LUNG;
 INABILITY OF LUNG TO FULLY EXPAND. 
AE381 
HYPOXEMIA  
DECREASED PARTIAL PRESSURE OF OXYGEN IN BLOOD SOMETIMES SPECIFICALLY AS LESS THAN 60 MMHG 
(8.0 
KPA)
 OR CAUSING HEMOGLOBIN OXYGEN SATURATION OF LESS THAN 90%. 
AE382 
PLEURAL EFFUSION -
 RIGHT 
EXCESS ACCUMULATION OF FLUIDS,
 SOMETIMES BLOOD IN THE PLEURAL SPACE,
 WHICH IS COMMON AFTER CARDIAC 
SURGERY.
 REPORTABLE WHEN IT BECOMES SYMPTOMATIC AND REQUIRES FLUID TO BE INTERVENTIONALLY 
REMOVED.
   
AE383 
PLEURAL EFFUSION -
 LEFT 
" 
AE384 
PLEURAL EFFUSION -
 BILATERAL 
" 
AE385 
PNEUMOTHORAX 
ACCUMULATION OF AIR OR GAS IN THE PLEURAL CAVITY,
 OCCURRING BECAUSE OF DISEASE OR INJURY AND 
REQUIRING SURGICAL INTERVENTION,
 HOSPITALIZATION OR MEDICAL INTERVENTION TO RESOLVE.
  
AE386 
PULMONARY EDEMA 
AN ABNORMAL ACCUMULATION OF FLUID IN THE LUNGS REQUIRING HOSPITALIZATION OR MEDICAL INTERVENTION TO 
RESOLVE. 
AE387 
PULMONARY HYPERTENSION 
MEAN PULMONARY ARTERY PRESSURE THAT IS GREATER THAN 25 MMHG AT REST AND/
OR GREATER THAN 30 MMHG 
DURING EXERCISE CONFIRMED BY SWAN GANZ CATHETER OR DIAGNOSTIC PLACEMENT IN THE PULMONARY ARTERY 
BED AND CONDITION REQUIRES HOSPITALIZATION OR MEDICAL INTERVENTION TO RESOLVE. 
AE388 
PULMONARY REGURGITATION 
THE BACKWARD FLOW OF BLOOD FROM THE PULMONARY ARTERY,
 THROUGH THE PULMONARY VALVE,
 AND INTO THE 
RIGHT VENTRICLE OF THE HEART DURING DIASTOLE. 
AE389 
PULMONARY EMBOLISM -
 RIGHT 
CLINICAL EVIDENCE OF NEW EMBOLISM WITH CONFIRMATION BY LUNG SCAN OR PULMONARY ANGIOGRAPHY. 
AE390 
PULMONARY EMBOLISM -
 LEFT 
" 
AE391 
PULMONARY EMBOLISM -
 BILATERAL 
" 
AE392 
PULMONARY/
RESPIRATORY -
 OTHER 
OTHER RESPIRATORY EVENT THAT IS NOT RESPIRATORY FAILURE.
  
AE393 
RESPIRATORY DYSFUNCTION/
INSUFFICIENCY 
DETERIORATION  OF  SUBJECT’
S  RESPIRATORY  EFFORTS  LESS  THAN 24  HRS  AFTER  COMPLETION  OF  THE  INDEX 
PROCEDURE. 

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 13 OF 15 
 
 

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 14 OF 15 
AE.10    PULMONARY/RESPIRATORY 
AE394 
RESPIRATORY FAILURE -
ASTHMA 
NEED  FOR  MECHANICAL  VENTILATION  REQUIRED  GREATER  THAN 24  HRS  AFTER  OF  COMPLETION  OF  THE  INDEX 
PROCEDURE (
TIME 0 =  WHEN  THE  SUBJECT  LEAVES  THE  OR),
  OR  NEED  FOR  RE-
INTUBATION  AND  VENTILATOR 
SUPPORT  OCCURRING  ANY  TIME  WITHIN 30  DAY  OF  THE  
INDEX  PROCEDURE  WILL  BE  CONSIDERED  RELATED  TO  THE 
INDEX PROCEDURE.
  
AE395 
RESPIRATORY FAILURE -
EMPHYSEMA 
" 
AE396 
RESPIRATORY FAILURE -
COPD 
" 
AE397 
RESPIRATORY FAILURE -
PNEUMONIA 
" 
AE398 
RESPIRATORY FAILURE -
PNEUMOTHORAX 
" 
AE399 
RESPIRATORY FAILURE -
HEMOTHORAX 
" 
AE400 
RESPIRATORY FAILURE -
 ARDS 
"
  ACUTE RESPIRATORY DISTRESS SYNDROME 
AE401 
RESPIRATORY FAILURE -
OTHER 
" 
AE402 
RESPIRATORY INFECTION – UPPER (
URI) 
THE ILLNESSES CAUSED BY AN ACUTE INFECTION WHICH INVOLVES THE UPPER RESPIRATORY TRACT:
 NOSE,
 SINUSES,
 
PHARYNX OR LARYNX.
 THIS COMMONLY INCLUDES:
 TONSILLITIS,
 PHARYNGITIS,
 LARYNGITIS,
 SINUSITIS,
 OTITIS MEDIA,
 
AND THE COMMON COLD. 
AE403 
RESPIRATORY INFECTION – PNEUMONIA  
LUNG  INFECTION  DOCUMENTED  BY  BLOOD  STUDIES  OR  CHEST  X-
RAY,
  REQUIRING  TREATMENT  WITH  ANTIBIOTICS,
 
INHALATION THERAPY,
 INTUBATION OR SUCTIONING. 
AE.11    PERIPHERAL VASCULAR 
AE420 
VASCULAR -
 ACCESS SITE COMPLICATION 
 COMPLICATIONS OF BLEEDING OR INFECTION AT THE SITE OF CARDIOPULMONARY ACCESS AND  OR PERCUTANEOUS 
CORONARY INTERVENTION OR DIAGNOSTICS THAT REQUIRE HOSPITALIZATION OR MEDICAL INTERVENTION. 
AE421 
VASCULAR -
 DEEP VEIN THROMBOSIS (
DVT) 
FORMATION  OF  BLOOD  CLOT (
THROMBUS)
  IN  THE  LOWER  EXTREMITIES (
LEGS)
  CHARACTERIZED  BY  SWELLING,
 
REDNESS,
 CLAUDICATION/
PAIN IN AFFECTED LIMB.
 EVENT SHOULD BE CONFIRMED BY DOPPLER OR DUPLEX US STUDY,
 
AND REQUIRES HOSPITALIZATION OR MEDICAL INTERVENTION TO RESOLVE.
  
AE423 
VASCULAR -
 OTHER 
OTHER VASCULAR COMPLICATIONS GENERALLY RELATED TO A DISEASE PROCESS AND NOT TRAUMA THAT REQUIRE 
HOSPITALIZATION OR MEDICAL INTERVENTION. 
AE.12    PSYCHIATRIC 
AE431 
PSYCHIATRIC DISORDER 
A  PSYCHOLOGICAL  OR  BEHAVIORAL  PATTERN  GENERALLY  ASSOCIATED  WITH  SUBJECTIVE DISTRESS  OR  DISABILITY 
THAT  OCCURS  IN  AN  INDIVIDUAL,
  AND  WHICH  IS  NOT  A  PART  OF NORMAL  DEVELOPMENT  OR  CULTURE.
  SUCH  A 
DISORDER  MAY  CONSIST  OF  A  COMBINATION  OF  AFFECTIVE,
  BEHAVIORAL,
  COGNITIVE  AND  PERCEPTUAL 
COMPONENTS. 
AE432 
SUICIDE 
A PERSON WHO INTENTIONALLY TAKES HIS OR HER OWN LIFE. 
AE433 
TRANSIENT PSYCHOTIC SYNDROME 
A MENTAL STATE OFTEN DESCRIBED AS INVOLVING A "
LOSS OF CONTACT WITH REALITY"
 THAT LASTS ONLY FOR A 

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 15 OF 15 
SHORT TIME. 
AE.12    PSYCHIATRIC (
CONTINUED) 
AE434 
PSYCHIATRIC – OTHER 
OTHER  NEUROLOGIC  EVENT  NOT  PREVIOUSLY  DESCRIBED  THAT  REQUIRES  HOSPITALIZATION  OR  MEDICAL 
INTERVENTION. 
AE.13    MUSCULAR SKELETAL/ DERMATOLOGIC 
AE450 
STERNAL WOUND/
THORACIC INFECTION 
DEEP  STERNAL  INFECTION  INVOLVING  MUSCLE,
  BONE,
  AND/
OR  MEDIASTINUM.
  MUST  INCLUDE  ONE  OF  THE 
FOLLOWING:
 1)  WOUND  OPENED  WITH  EXCISION  OF  TISSUE (
I&D);
 2)  POSITIVE  CULTURE;
 3)  TREATMENT  WITH 
ANTIBIOTICS.
 (
LAST  SENTENCE  REMOVED,
  WHICH  IMPLIES  THAT  BACTERIAL  PNEUMONIA  AFFECTING  PARTS  OF  THE 
LUNG  ADJACENT TO THE STERNUM SHOULD BE COUNTED AS A STERNAL WOUND INFECTION.) 
AE451 
BONE FRACTURE/
BREAK 
A BREAK IN BONE OR CARTILAGE.
 ALTHOUGH USUALLY THE RESULT OF TRAUMA,
 A FRACTURE CAN BE CAUSED BY AN 
ACQUIRED DISEASE OF BONE SUCH AS OSTEOPOROSIS OR BY ABNORMAL FORMATION OF BONE IN A DISEASE. 
AE452 
WOUND INFECTION – OTHER 
OTHER WOUND INFECTION THAT IS NOT RELATED TO THE SURGICAL ACCESS SITE. 
AE454 
INFECTION /
INFLAMMATION -
 OTHER 
SOURCE  OF  INFECTION  THAT  IS  CHARACTERIZED  BY  ELEVATED  BLOOD  LEVELS  AND  OR  FEVER  REQUIRING 
HOSPITALIZATION OR MEDICAL INTERVENTION (
FEVER OF UNKNOWN ORIGIN FUO;
 CLINICALLY SIGNIFICANT ELEVATED 
WBC)  
AE456 
MUSCULAR SKELETAL /
 DERMATOLOGIC -
 OTHER                            OTHER SKIN/
MUSCULAR/
SKELETAL EVENT NOT PREVIOUSLY DESCRIBED THAT REQUIRES HOSPITALIZATION OR 
MEDICAL INTERVENTION. 
AE.14    NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM 
AE470 
ANAPHYLACTIC REACTION 
AN  ALLERGIC  REACTION  TO  AN ANTIGEN  THAT  CAUSES  CIRCULATORY  COLLAPSE  AND  SUFFOCATION  DUE  TO 
BRONCHIAL AND TRACHEAL SWELLING. 
AE471 
ALLERGIC REACTION – MEDICATION RELATED 
 A MILD TO MODERATE TO LIFE THREATENING REACTION TO A SUBSTANCE AND/
OR MEDICATION.
   REPORT REACTIONS 
THAT REQUIRE HOSPITALIZATION OR MEDICAL INTERVENTION. 
AE472 
ALLERGIC REACTION – OTHER  
 A MILD TO MODERATE TO LIFE-
THREATENING REACTION TO AN ENVIRONMENTAL OR ANIMAL SUBSTANCE.
 REPORT 
REACTIONS THAT REQUIRE HOSPITALIZATION OR MEDICAL INTERVENTION. 
AE473 
CANCER – PROGRESSION OF UNDERLYING DISEASE 
AN EXACERBATION OR WORSENING OF A CANCER DIAGNOSED/
KNOWN PRIOR TO THE INDEX PROCEDURE.
  
AE474 
CANCER – NEWLY DIAGNOSED  
A NEWLY DIAGNOSED CANCER FOLLOWING INDEX PROCEDURE. 
AE475 
HEARING DISORDER 
ANY DISORDER RELATED TO HEARING IMPAIRMENT REQUIRING HOSPITALIZATION OR MEDICAL INTERVENTION. 
AE476 
MULTI-
SYSTEM ORGAN FAILURE 
OCCURS WHEN MORE THAN ONE ORGAN OF THE BODY STOPS FUNCTIONING NORMALLY AND HOMEOSTASIS CANNOT 
BE MAINTAINED WITHOUT INTERVENTION.
  
AE477 
SPEECH DISORDER 
ANY DISORDER RELATED TO A SPEECH IMPEDIMENT REQUIRING HOSPITALIZATION OR MEDICAL INTERVENTION. 
AE479 
VISION DISORDER 
ANY DISORDER RELATED TO VISION IMPAIRMENT REQUIRING HOSPITALIZATION OR MEDICAL INTERVENTION. 
AE480 
FEVER -
 UNKNOWN ORIGIN  
(1)
 A TEMPERATURE GREATER THAN 38.3°C (101°
F)
 ON SEVERAL OCCASIONS,
 (2)
 MORE THAN 3 WEEKS'
 DURATION 
OF ILLNESS,
 AND (3)
 FAILURE TO REACH A DIAGNOSIS DESPITE 1 WEEK OF INSUBJECT INVESTIGATION. 

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 16 OF 15 
AE481 
NONSPECIFIC,
 UNKNOWN,
 OR OTHER BODY SYSTEM -
 OTHER 
COMPLICATION 
ANY COMPLICATION THAT CANNOT OTHERWISE BE CATEGORIZED REQUIRING HOSPITALIZATION OR MEDICAL 
INTERVENTION. 
AE.15    DEVICE DYSFUNCTION 
AE500 
SVD -
 STUDY VALVE WEAR 
INCLUDES DYSFUNCTION OR DETERIORATION INVOLVING THE OPERATED VALVE (
EXCLUSIVE OF INFECTION OR 
THROMBOSIS).
 THE TERM STRUCTURAL VALVE DETERIORATION REFERS TO CHANGES INTRINSIC TO THE VALVE SUCH 
AS:
 WEAR,
 FRACTURE,
 CALCIFICATION,
 LEAFLET TEAR,
 MANUFACTURED SUTURE LINE DISRUPTION 
AE501 
SVD -
 STUDY VALVE FRACTURE 
" 
AE502 
SVD -
 STUDY VALVE POPPET ESCAPE 
" 
AE503 
SVD -
 STUDY VALVE CALCIFICATION 
" 
AE504 
SVD -
 STUDY VALVE LEAFLET TEAR 
" 
AE505 
SVD -
 STUDY VALVE STENT CREEP 
" 
AE506 
SVD -
 STUDY VALVE SUTURE LINE DISRUPTION 
" 
AE507 
SVD -
 STRUCTURAL VALVE DETERIORATION,
 OTHER      
" 
AE525 
SVD -
 ANNULAR FRAME DAMAGE 
" 
AE526 
SVD -
 ANNULAR FRAME SEPARATION 
" 
AE527 
SVD -
 STENT FRAME FRACTURE 
" 
AE528 
SVD -
 STENT FRAME DEFORMATION 
" 
AE529 
SVD -
 STENT FRAME SEPARATION 
" 
AE512 
NSD -
 ENTRAPMENT BY PANNUS,
 TISSUE,
 OR SUTURE 
ANY  ABNORMALITY  NOT  INTRINSIC  TO  THE  VALVE (
DO  NOT  DIRECTLY  INVOLVE  VALVE  COMPONENTS)
  ITSELF  THAT 
RESULTS  
IN  STENOSIS  OR  REGURGITATION  OF  THE OPERATED  VALVE  OR  HEMOLYSIS (
EXCLUDES  THROMBOSIS  AND 
INFECTION).
    EXAMPLES  INCLUDE:
  ENTRAPMENT  BY  PANNUS,
  TISSUE,
  OR  SUTURE,
  PARAVALVULAR  LEAK,
 
INAPPROPRIATE  SIZING,
  INAPPROPRIATE  POSITIONING,
  REGURGITATION  AS  A  RESULT  OF  TECHNICAL  ERROR,
  STJ 
DILATION,
 DILATION OF THE VALVE ANNULUS,
 OBSTRUCTION OF THE CORONARY OSTIA BY THE STUDY VALVE. 
AE164 
NSD -
 PARAVALVULAR LEAK -
 +1 
LEAKAGE BETWEEN THE SEWING RING AND THE ANNULUS.
   
AE165 
NSD -
 PARAVALVULAR LEAK -
 +2 
" 
AE166 
NSD -
 PARAVALVULAR LEAK -
 +3 
" 
AE167 
NSD -
 PARAVALVULAR LEAK -
 +4 
" 
AE176 
NSD -
 STUDY VALVE STENOSIS -
 MILD 
NSD " 

 
 
 
Clinical Investigational Plan 
 
Protocol Number: 2010‐03 
AE CODE LIST 
CODE   LABEL/NAME 
DEFINITION 
 
CONFIDENTIAL AND PROPRIETATARY DATA: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN MAY NOT BE REPRODUCED,
 USED,
 OR DISCLOSED WITHOUT WRITTEN PERMISSION FROM EDWARDS LIFESCIENCES LLC 
REVISION C: 8 MAY 2012 
 
 
PAGE 17 OF 15 
AE177 
NSD -
 STUDY VALVE STENOSIS -
 MODERATE 
NSD " 
AE178 
NSD -
 STUDY VALVE STENOSIS -
 SEVERE 
NSD " 
AE121 
NSD -
 PARAVALVULAR LEAK WITH HEMOLYSIS 
NSD " 
AE514 
NSD -
 INAPPROPRIATE SIZING 
NSD " 
AE515 
NSD -
 INAPPROPRIATE POSITIONING 
NSD " 
AE516 
NSD -
 RESIDUAL LEAK OR OBSTRUCTION 
NSD " 
AE517 
NSD -
 INTRAVASCULAR HEMOLYTIC ANEMIA 
NSD "
 CLINICALLY IMPORTANT 
AE518 
NSD -
 DEVELOPMENT OF REGURGITATION  
NSD "
 AS A RESULT OF TECHNICAL ERRORS 
AE519 
NSD -
 DILATATION OF THE SINOTUBULAR JUNCTION 
NSD " 
AE520 
NSD -
 DILATION OF THE VALVE ANNULUS 
NSD " 
AE521 
NSD -
 CORONARY OSTIAL OBSTRUCTION 
NSD " 
AE522 
NSD -
 STUDY VALVE INSTABILITY 
NSD " 
AE523 
NSD -
 STUDY VALVE MIGRATION 
NSD " 
AE524 
NSD -
 LVOT DAMAGE 
NSD " 
 

Edwards Pericardial Aortic Bioprosthesis, Model 11000 
Clinical Trial Number: 2010‐03 
 
Revision C: 8 MAY 2012 
Confidential
Page 36of 42
 
15.2 SAMPLE INFORMED CONSENT FORM 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Patient Informed Consent Form 
DRAFT:  8 MAY 2012 
1 of 9 
 
Patient Information 
 
CLINICAL STUDY # 2010‐03: 
“Clinical Study of the Edwards Pericardial Aortic Bioprosthesis, Model 11000” 
   
You are invited to take part in a clinical research study. This information sheet tells you why the 
research is being done and what it would involve for you if you chose to take part. Please read the 
following information carefully and feel free to discuss this with your family or your Doctor. If you are 
unclear about anything or would like more information, please contact, <Name> on <Tel. number>. 
Take  time to decide whether or not you wish to take part. Your participation in this research study is 
voluntary. If you decide to participate we will ask you to sign this consent document in order to state 
your agreement. 
This study has been given a favorable opinion by the <Ethics Committee> and by the <Competent 
Authority>. It will be conducted according to the regulations governing clinical research. 
INTRODUCTION 
The heart is a muscle, that works like a pump, moving blood into the lungs and the entire body. In 
the heart there are 4 valves, whose role is to allow blood to flow in the correct direction. When a 
valve doesn’t work properly, the heart muscle has to work harder to pump the normal amount of 
blood around the body. This may cause symptoms such as tiredness,  difficulty in breathing, fainting 
or in some cases a condition called angina pectoris. The symptoms are different depending on the 
valve that is damaged and the amount of the damage. If the symptoms are serious the  valve can be 
surgically removed and replaced with a new valve. There are different types of replacement valves 
that are used based on a patients condition and symptoms. One type is the biological valve, 
sometimes refered to as a tissue valve or bioprosthesis. Bioprostheses made with pericardial tissue 
have been used for many years.  
WHAT IS THE PURPOSE OF THIS STUDY? 
The purpose of this observational trial is to gather further clinical data to confirm the safety and 
performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 (also referred to as the 
Model 11000).  
WHY CAN YOU PARTICIPATE IN THIS RESEARCH STUDY? 
You are being invited to participate in this clinical research study  because it has been determined 
that your aortic heart valve needs replacement and your doctor believes that you may benefit from 
receiving a biological valve. 
A variety of biological heart prostheses are available from different manufacturers. In this study we 
intend to test the Model 11000 aortic biological prosthesis. The Model 11000 prosthesis is a new CE 
marked product. This new aortic valve was developed to treat patients having aortic valve diseases 
called stenosis or insufficiency, like you. 

 
Patient Informed Consent Form 
DRAFT:  8 MAY 2012 
2 of 9 
 
STUDY DESIGN  
This study will be conducted in up to 6 participating hospitals. 
 You may be one of approximately 200 participants invited to participate.  
Your participation will last for 5 years.  All participants will have to return to the hospital where the 
surgery was done and be checked by the study doctor or his colleagues on a regular basis. Following 
discharge you will be asked to return to the hospital at 3 months, 1 year, and annually until 5 years 
after the valve was implanted in your heart.  
DESCRIPTION OF THE EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS MODEL 11000  
The Edwards Pericardial Aortic Bioprosthesis Model 11000A is a CE marked device. The Model 
11000A is identical to the Model 11000. 
The Model 11000 valve is a CE marked Carpentier‐Edwards PERIMOUNT Magna Ease 3300TFX valve, 
with modifications in tissue processing and valve sterilization.   
The Magna Ease valve consists of three tissue leaflets made of bovine (cow) pericardium (heart 
tissue). These leaflets have been treated with a new Edwards tissue process, built on the CE marked 
Edwards ThermaFix process to stabilize and preserve tissue. This process also allows the Model 
11000 to be stored in non‐liquid packaging and to not require rinsing prior to implant.  
HOW WAS THE VALVE UNDER INVESTIGATION TESTED? 
The valve was tested in conformity with European Regulations. The results of these tests have shown 
that the valve is suitable for implant in humans. 
The technique used for implanting the valve is similar to the one your doctor uses with other 
biological heart valves. Each of the study doctors involved in this clinical study has been properly 
trained on how to implantat the Model 11000. 
WHAT WILL HAPPEN TO ME IF I TAKE PART? 
If you agree to participate in this study, you receive the same treatment as any other patient having a 
similar operation, although you will also have some more tests (described below). The extra tests will 
enable us to to collect more information about the valve and the surgery. 
The decision about participating in this study is entirely yours. 
Before your surgery, your doctor will discuss the study and answer any questions you may have. If 
you consent to participate you will be asked to sign and date an informed consent form. A copy of 
this form will be given to you.  
The study doctor will then ask you questions and will run tests and procedures to see if you can 
participate in the study. These tests and procedures include: 
  A screening assessment to see if you are eligible to participate in the study 
  Your medical history will be reviewed  
  You will be given a physical examination (a clinical evaluation of your condition), and any 
findings will be written down in the study chart 

 
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  The severity of your health will be graded using a standard scale called NYHA based on your 
ability to do physical activities.  
  Your quality of life will be measured by two short health questionnaires 
  You will have an echocardiogram (a machine that creates sound waves that can see the 
inside of your heart. The pictures are taken with a small probe that is put on the outside of 
your chest) 
  You will have an electrocardiogram (a machine that records the electrical activity of your 
heart. The recording is done by putting self adhesive discs on your chest) 
  Your blood will be collected for laboratory testing.  The blood test will require a needle being 
inserted into a vein in your arm (or other area where a vein can be accessed). Approximately 
three teaspoons (15ml) of blood will be drawn at this visit for routine tests.  Any remaining 
blood sample will be discarded according to hospital regulations. 
  If you are a woman of child‐bearing age (and are not sterile) a small amount of blood or urine 
will be obtained to check for pregnancy. 
 
If the results of the tests and examinations do not meet the study requirements and your doctor 
assesses that you are not qualified to participate in the study, you will be excluded from the study 
and the study doctor will discuss with you an alternative treatment for your disease. No further 
commitments related to this study will be requested of you. 
If, as a result of the above mentioned tests and examinations, your doctor assesses that you are 
eligible to participate in the study, you will be scheduled for your surgery. 
This surgical procedure is performed under general anaesthesia as is normal for heart valve 
replacement. The cardiac surgeon will open the chest to enable access to the heart and will place 
your heart on a  “heart‐lung” machine while they operate on the valve. During your surgery and 
before the Model 11000 is implanted a small tube called a transesophageal ultrasound will be 
entered through your mouth and advanced down to the area of the heart. The doctor will use this 
ultrasound to take pictures of your heart and ensure it functions well once implanted. These are 
parts of every surgery to replace a heart valve.  
If during surgery your study doctor finds a reason not to implant the Model 11000, you will receive 
another equivalent aortic Bioprosthesis approved in the market. You will be excluded from the study 
and you will not have any further commitments related to this study. 
If your study doctor assesses that there are no further contraindications, your will receive the Model 
11000  valve and will be considered enrolled in the study.  
 
After your surgery and before you go home, you will have some more tests and examinations as 
described below: 
  A physical examination will be performed 
  Your blood will be collected for laboratory testing in order to determine the best  
pharmacological treatment for you 
  An echocardiogram (a sound wave taking pictures of your heart) will be obtained to see that 
the newly implanted Model 11000 valve sits well in its position and that it works well 
  You will have an electrocardiogram (recording of the electrical activity of your heart) 

 
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  You will be asked if you have experienced any unusual symptoms or side effects since the 
procedure – any finding will be recorded in order to control your health  
  An appointment will be scheduled for you to return to the study center approximately 3 
months after your procedure date. 
 
During your 3 months and subsequent annual follow‐up visits, you will be asked to provide 
information about your health status and you will undergo the following procedures: 
  A physical examination 
  An electrocardiogram (electrical recording of the heart)  
  An echocardiogram (sound wave taking pictures of your heart) 
  Your health condition will be graded based on your ability to perform physical activities 
(NYHA class) 
  Your quality of life will be measured by two short health questionnaires (only at 1‐year 
follow‐up visit) 
  Your blood will be collected for laboratory testing in order to determine the best 
pharmacological treatment for you 
  You will be asked if you have experienced any unusual symptoms or side effects since your 
last assessment 
  An appointment will be scheduled for you to return to the study center approximately at 1 
year from your procedure date. 
PARTICIPANT RESPONSIBILITIES 
If you decide to participate in this research study, you will have to follow the instructions given by 
your study doctor and his colleagues and come back to the hospital for all the follow up visits until 
the fifth follow up year. Completing all study visits is important to make sure that the study results 
are complete and accurate.  If you wish to stop participating in the study or if you find you have not 
followed instructions listed above, it is important that you notify the study doctor or study staff. 
Your participation in this research study is entirely voluntary and it is your right to refuse to 
participate or withdraw at any time without penalty or loss of benefits to which you are otherwise 
entitled.  You are free to withdraw from the study at any time without giving any reason, even if you 
have confirmed in writing that you want to take part.  Your decision to withdraw will not have any 
adverse effect whatsoever on your further treatment in our hospital. 
Giving false, incomplete, or misleading information about your medical history, including past and 
present use of medications, could have a very serious effect on your health.  It is very important 
that you give a true and complete medical history. 
WHAT ARE THE POSSIBLE BENEFITS OF TAKING PART? 
There are no guaranteed benefits from participation in this clinical investigation.   
The potential benefit resulting from this clinical study beyond those afforded by a routine valve 
replacement may be a slightly shortened procedure time. 

 
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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 may include palliative medical therapy, aortic balloon 
valvuloplasty and surgical replacement of the aortic valve with another prosthesis. 
WHAT ARE THE POSSIBLE RISKS OF TAKING PART? 
You must understand that the treatment of choice for your condition is a heart valve replacement 
and that alternative valves are available.  
As with all prosthetic heart valves, there is a possibility that serious complications, sometimes leading 
to death, could develop that were not anticipated. In addition, complications due to individual 
patient reaction to an implanted device, or to physical or chemical changes in the components, 
particularly those of biological origin, may occur at varying intervals (hours or days) necessitating 
reoperation and replacement of the prosthetic device. These risks will be explained to you by your 
study doctor. Should any side effects occur, they will be fully assessed and you will be monitored 
closely. 
You may experience events and/or outcomes that may include, but are not necessarily limited to, the 
following: 
 Allergic reaction or immunological response 
 Angina (chest pain) 
 Aortic wall and or annulus damage 
 Cardiac arrhythmias /  Conduction interference (change in the heartbeat rhythm) 
 Chordae damage or trauma (damage to the mitral valve structure) 
 Coronary ostia blockage (occlusion) 
 Endocarditis (infection of the valve) 
 Heart failure 
 Hemolysis (Breaking open of red blood cells with release of hemoglobin) 
 Hemolytic anemia 
 Hemorrhage (bleeding related to the use of anticoagulant therapy) 
 Myocardial infarction 
 Prosthesis leaflet entrapment (Impingement) 
 Prosthesis nonstructural dysfunction 
 Prosthesis pannus (excessive tissues growth around the valve) 
 Prosthesis Paravalvular leak (blood leaking around the valve when it is closed) 
 Prosthesis regurgitation (blood leaking through the valve when it is closed) 
 Prosthesis stenosis / Effective Orifice Area reduction (narrowing of the valve) 
 Prosthesis structural deterioration (physical or chemical deterioration of valve components) 
 Prosthesis thrombosis (blood clot attachment to the valve) 
 Stroke or transient ischemic attack (TIA) 
 Tissue deterioration including infection, calcification, thickening, perforation, de‐generation, 
suture abrasion, instrument trauma, and leaflet detachment from the valve  
 Thromboembolism 
 Thrombotic obstruction 
 
It is possible that these complications could lead to:  
 Reoperation 
 Explantation 
 Permanent disability 

 
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 Death 
WHAT HAPPENS IF I DECIDE AGAINST PARTICIPATING IN THE CLINICAL STUDY? 
If you decide not to participate in the study you can discuss with your doctor which options of heart 
valve replacement best suit your requirements. This does not in any way affect your further medical 
care. 
WHAT IF SOMETHING GOES WRONG? 
Your doctor and the company that makes the valve (Edwards Lifesciences LLC (Irvine, CA)) will take 
all appropriate efforts to prevent you having any injury or illness which may occur as a result of your 
participation in this study. If you suffer any injury or illness as a direct result of participating in this 
study, you will receive medical care and treatment at this hospital. Signing this consent does not 
affect any legal rights you have.  
As per the laws in your country, insurance has been taken out (Insurance company details). 
Make sure you notify the insurance company without delay if you notice any deterioration in your 
state of health which may be related to the clinical study. Any such report may also be made by the 
study Investigator, your doctor. 
WILL MY TAKING PART IN THIS STUDY BE KEPT CONFIDENTIAL? 
This section explains how your medical and health records might be used and disclosed if you agree 
to participate in this study. 
All physicians involved in the study follow a strict clinical protocol. You have the right to determine 
who has access to your health records.  Records collected in this study may include your medical 
history, the results of physical examinations, laboratory tests and other diagnostic or treatment 
procedures, as described above in this consent form, as well as basic demographic information. 
By signing this form: 
  You allow the study staff and/or the study doctor to use your medical records for the study 
and to disclose your health information to the sponsor, Edwards Lifesciences, LLC., or to the 
sponsor’s representatives, in order to review the results of the study and to monitor the 
safety of participants. 
  You allow the study doctor and/or sponsor to publish the results of the study or discuss the 
results at conferences. If this is done, no information will be included that would reveal your 
identity. 
The information sent by the study doctor and/or study staff to the Sponsor will be anonymised, that 
means it will not include your name, address, or any other means of identification.  Instead, the 
study doctor will use an assigned coded number to the records that are provided to the sponsor.  
However, your entire medical record may be reviewed at the study doctor’s office and/or hospital by 
the Sponsor and/or Sponsor representatives, by regulatory/government agencies and the 
independent ethics committee (EC ‐ is a group that has been formally designated to review and 
monitor research involving human subjects).  The purpose of these reviews is to assure the quality of 
the study and patient safety. 

 
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The study doctor and/or study staff will make every effort to protect the privacy of your information.  
However, absolute confidentiality cannot be guaranteed because of the need to disclose information 
as described above.   
You can cancel this authorization at any time by giving a written notice to the study doctor.  If you 
cancel this authorization, then you will no longer be able to participate in the study, and the 
information that has been collected prior to canceling the authorization may still be used and 
disclosed to the above‐mentioned parties. You will receive a signed copy of this consent for your 
records. 
All data collected within the scope of the study may be forwarded to other persons or institutions 
not authorized for direct data inspection in an anonymized form only. We will inform your local 
doctor (general practitioner), only if you allow. 
PARTICIPATION AND WITHDRAWAL 
You have the right to choose not to participate in this study or to stop participating at any time, 
without any consequences.  This means that there will be no penalty or loss of medical benefits to 
which you are entitled. 
If you choose to stop being a part of this study, you must first notify the study doctor immediately so 
that a plan can be provided for your continued medical care.  At the time you stop taking part in the 
study, you will be asked to return for a final safety evaluation that will include gathering information 
about your current medical condition and conducting any required procedures.  For your own safety, 
you should go through the study exit procedures any time you leave the study and make 
arrangements for your follow up care. 
It is possible that your participation in this study may be stopped at any time.  This might happen if 
you do not follow the instructions given by the study doctor or if the study doctor believes it to be in 
your best interest.  The study may also be stopped for administrative, medical, or other reasons as 
determined by the study doctor or Edwards Lifesciences, LLC., or the regulatory authorities of the 
counties where this clinical study is conducted.   Any significant new findings developed during the 
course of this research that might affect your willingness to participate will be provided to you by 
your doctor. 
While participating in this study, you should not take part in any other study.  This is to protect you 
from possible unforeseen injuries that may arise. 
WHO IS ORGANISING AND FUNDING THE RESEARCH? 
This study/research is organized by Edwards Lifesciences, LLC. the medical device company manufacturing 
the Model 11000 
valve and the Sponsor of this study.   
1. The Sponsor reimburses the institution for tests and procedures needed for this study.  
2. The study staff will not be paid to include you in this study but the hospital will be 
reimbursed for the costs incurred in conducting this research. 
COSTS  AND COMPENSATION 
There will be neither charge, nor compensation, for your participation in this study.  The 
investigational device, study‐related procedures, and study visits will be provided at no charge.   

 
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You will be reimbursed for the travel expenses you face in order to come back to the hospital for the 
follow‐up visits requested by this study 
You will still be responsible for the cost of your usual ongoing medical care, including procedures 
and/or non‐study drugs that are not required by this study.  If you have any questions, please ask the 
study doctor, a member of the study staff.  
CONTACT DETAILS FOR FURTHER INFORMATION 
If you require any further information before or during the study, or if you have any questions after 
you have read this Patient Information, please contact the investigator responsible for you: 
__________________________________________________________________________________ 
Telephone:  ________________________________________________________________________  
 
 
FURTHER INFORMATION 
 
You consent to participate in a scientific study and in the statistical analysis of the results of that 
study. It is understood that your personal data continue to be subject to data protection and shall 
not be disclosed to any third parties. Participation in this study is voluntary, and you can 
discontinue participation at any time without giving reasons, and without penalty. The Principal 
Investigator or the sponsor may also decide on your premature discontinuation of this study. 
 

 
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CONSENT FORM 
 
Title of the project:   Clinical study of an Edwards model 11000 aortic valve 
Name of the Principal Investigator:                    
Center number:                           
 
Study number:                                 
 
Patient Indentification Number:                 
 
Please initial box  
 
1. I confirm that I have read and understand the information sheet dated  
            
(version      ) for the above study. I have had the opportunity to consider the 
information, ask questions and have had these answered satisfactorily. 
 
2. I understand that my participation is voluntary and that I am free to withdraw at 
 
any time without giving any reason, without my medical care or legal rights being 
affected. 
 
3. I understand that relevant sections of my medical notes and data collected     
 
during the study, may be looked at by individuals from Edwards Lifesciences, 
from regulatory authorities where it is relevant to my taking part in this research. 
I give permission for these individuals to have access to my records. 
 
4. I agree to my GP being informed of my participation in the study.         Yes   No   
 
5. I agree to take part in the above study.  
                                
 
 
 
                                                               
Name of Patient                    Signature                Date 
 
                                                               
Name of legal representative           Signature                Date 
(if applicable) 
 
I attest that I discussed this study with the above named participant.  This person had enough time to 
consider the information, had an opportunity to ask questions, and voluntarily agreed to participate 
in this study. 
 
                     
                                      
Name of person taking consent 
 
          Signature                Date 

Edwards Pericardial Aortic Bioprosthesis, Model 11000 
Clinical Trial Number: 2010‐03 
 
Revision C: 8 MAY 2012 
Confidential
Page 37of 42
 
15.3 CASE REPORT FORMS  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Subject has acute myocardial infarction (MI) within 30 days prior to AVR surgery
Yes
Subject has aneurysm of the aortic root and/or ascending aorta requiring surgical
Yes
No      Subject requires a surgical procedure outside of the cardiac area (e.g. vascular
Yes
No      Subject has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or
Subject is diagnosed with aortic valve disease requiring a planned replacement as
Yes
Yes
No
No
No
Subject is 18 years or older
Subject requires multiple valve replacement/repair
Yes
2.  
No
of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
Subject has renal insufficiency as determined by creatinine (S-Cr) level >= 2.5 mg/dL
Yes
No      Subject has active endocarditis/myocarditis or endocarditis/myocarditis within
Subject has prior mitral, tricuspid or pulmonic valve surgery, which included implant
Yes
No
PREOPERATIVE INCLUSION / EXCLUSION CRITERIA
Subject requires emergency surgery
Yes
No
Rev B
transient ischemic attack (TIA) within 6 months (180 days) prior to AVR surgery
Subject is geographically stable and agrees to attend follow-up assessments at
Please indicate when the subject signed the informed consent form:
(HH:MM)
Time:
(DD/MMM/YYYY)
Date:
Yes
No
1.
3.
Subject provided written informed consent prior to trial procedures
Yes
No      Subject is scheduled to undergo planned aortic replacement with or without
Yes
11.
No
concomitant coronary bypass surgery
8.
5.
intervention
4.
Please indicate whether or not the subject meets the following inclusion criterion
bypass)
10.
Please indicate whether or not the subject meets any of the following exclusion criterion
7.
3 months to the scheduled aortic valve replacement (AVR) surgery
indicated in the preoperative evaluation
3.
6.
9.
12 months
4.
2.
or end-stage renal disease requiring chronic dialysis at screening visit
Yes
5.
No      Subject is diagnosed with hypertrophic obstructive cardiomyopathy (HOCM)
Yes
No
Yes
1.
No
the hospital of surgical services for up to 5 years
Subject has presence of non-cardiac disease limiting life expectancy to less than
Yes
No

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Subject has documented leukopenia (WBC < 3.5x 10^3/uL), acute anemia
(Hgb < 10.0 gm/dL or 6 mmol/L), thrombocytopenia (platelet count < 50x10^3/uL)
14.
16.
20.
intraoperative evaluation?
procedure within 30 days prior to AVR surgery
17.
18.
Has a surgery date for this subject been scheduled?   
No   Yes
(DD/MMM/YYYY)
Please indicate the estimated surgery date:
(e.g. Marfan
's Syndrome)
Yes
21.
No
22.
13.
Yes
No      Subject has echocardiographic evidence of an intra-cardiac mass, thrombus,
Yes
No
19.
AVR surgery
or vegetation
Subject is pregnant (female subject of childbearing potential only), lactating
Yes
No
23.
Subject was previously implanted with trial device
or planning to become pregnant during the duration of participation in trial
last 5 years prior to implant
drug or device trial
or history of bleeding diathesis or coagulopathy
Yes
No      Subject has hemodynamic or respiratory instability requiring inotropic support,
Yes
No      Subject has documented history of substance (drug or alcohol) abuse within the
Yes
Yes
No      Subject is currently incarcerated or unable to give voluntary informed consent
Yes
No
Subject exhibits left ventricular ejection fraction =< 30% as validated by diagnostic
Yes
No
No
mechanical circulatory support, or mechanical ventilation within 60 days prior to
Current or recent participation (within 6 weeks prior to surgery) in an investigational
Subject is diagnosed with hyperparathyroidism
Yes
No      Subject has prior organ transplant
Based on the answers to the preoperative inclusion and exclusion criteria, is this subject eligible for
Yes
No      Subject is diagnosed with myxomatous disease/connective tissue disorders
Yes
No
12.
15.

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
implanting the study device
No
Rev B
Yes
Was the subject enrolled in the study?
No
3. Subject is hemodynamically unstable during the
2. The device is not available in the correct size for the
Yes
1. Position of the coronary ostia relative to the study valve 
that would result in obstruction of blood flow
No
subject
procedure requiring the procedure to be aborted prior to
Yes
INTRA-OPERATIVE EXCLUSION CRITERIA
No
Yes
after intra-operative evaluation and prior to a trial valve
Please specify:
Does the subject have the following anatomic variances which contraindicate implant of the valve?
Yes
No
implant attempt for any other reason
4. Surgeon determined that a trial valve cannot be implanted

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Rev B
Please indicate the subject
's race:
Please specify:
Please specify:
Please indicate the subject
's ethnicity:
Birth date:
Is the subject willing to identify their race/ethnicity?
Year (YYYY) and age
Was a pregnancy test performed?
No
Yes
What was the result?
Why was the pregnancy test not performed?
Please specify:
Birth date (DD/MMM/YYYY)
What format will be used to indicate the subject
's age?
DEMOGRAPHICS
Age:
Age:
Year:
Female
Male
Gender:
Yes
No

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
in
%
Was this result clinically significant?
Yes
No
Yes
No
Is this value within the normal range?
What is the subject's baseline serum creatinine value (mg/dL)?
What is the subject's current Left Ventricular Ejection Fraction (LVEF)?
cm
What is the subject's Canadian Cardiovascular Society (CCS) Angina Class?
Subject height:

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
disease; or prior documentation of blood pressure > 130 mmHg
systolic or 80 mmHg diastolic on at least 2 occasions for patients with
with medication, diet and/or exercise
Please indicate if the subject:
Has a documented history of hypertension diagnosed and treated
Has prior documentation of blood pressure >140 mmHg systolic
No    Yes
No    Yes
or 90 mmHg diastolic for patient without diabetes or chronic kidney
Is currently on pharmacologic therapy to control hypertension
No    Yes
diabetes or chronic kidney disease
No    Yes
Circumflex coronary artery
No    Yes
Right coronary artery
No    Yes
Left main coronary artery
Please indicate which native coronary vessels have >= 50% narrowing:
No    Yes
Left anterior descending (LAD) coronary artery
Yes
No
Please indicate the type of cardiomyopathy
Yes
No
Cardiomyopathy
Coronary Artery Disease (CAD)
Does the subject currently have or has the subject ever had the following diseases / conditions?
Yes
CARDIOVASCULAR MEDICAL HISTORY / RISK FACTORS
MEDICAL HISTORY (Part 1)
No
Systemic Hypertension
Yes
No
Pulmonary Hypertension
Please indicate which symptoms the subject has experienced:
Claudication
No    Yes
>50% stenosis of any peripheral artery
No    Yes
Aortic aneurysm
No    Yes
Yes
No
What is the severity of the condition?
Peripheral Artery/Vascular Disease
Please indicate the severity of the disease:
Yes
No
Carotid Artery Disease
Rev B

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Please indicate the last known severity:
Please indicate the last known severity:
Please indicate the last known severity:
Non ST-elevation MI (NSTEMI)
No    Yes
Other type of MI
ST elevation MI (STEMI)
No    Yes
What types of myocardial infraction (MI) has the subject experienced?
Is the date (DD/MMM/YYYY) when the last known MI occurred known?
Date of last known MI:
Is the approximate number of months since the occurrence of the last MI known?
No   
Yes
Number of months:
Did the event occur >5 years ago?  No   
Yes
No
No    Yes
Please specify:
Yes
Unknown type of MI
No    Yes
No
Aortic Insufficiency
Yes
No
Aortic Stenosis
Tricuspid Stenosis
Yes
No
Yes
No
Congestive Heart Failure (CHF)
Yes
No
Mitral Stenosis
Yes
Mitral Insufficiency
Yes
No
Myocardial Infarction (MI)
Yes
No
Tricuspid Insufficiency
Yes
No

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
No
Sinus  tachycardia
No    Yes
Sinus  bradycardia
No    Yes
Atrial flutter
No    Yes
Ventricular tachycardia
No
Tachycardia-bradycardia syndrome
No    Yes
Yes
Other cardiac rhythm abnormality
No    Yes
No    Yes
No
AV block
No    Yes
Yes
Has the subject ever had the following cardiac rhythms?
Atrial fibrillation / Supraventricular tachycardia
Please indicate the episodic pattern for VT
Please specify:
Has the subject ever shown sign of the following conduction disturbances?
Indicate the last recorded degree of AV Block:
Bundle branch block
Indicate branch:
Other conduction disturbance
Please specify:
No    Yes
Yes
Please indicate the episodic pattern:
Is this a permanent condition?   No
Cardiac rhythm abnormalities/conduction disturbances
Yes

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
No    Yes
No   Yes
Does the subject have severe impairment of mobility as a result of a neurological
No     Yes
Please indicate if the subject has experienced the following types of cerebrovascular events:
Transient ischemic attack (TIA; recovered within 24 hours)
Cardiovascular accident / Stroke (CVA; did not recover within 24 hours)
No    Yes
Is the date when the last known CVA occurred known?
Date of last known CVA:
Did the event occur > 5 years ago?   
No    Yes
CVA known?
Number of weeks:
Is the approximate number of weeks since the occurrence of the last
No    Yes
No    
Yes
Is the date when the last known TIA occurred known?
Date of last known TIA:
Is the approximate number of months since the occurrence of the last
No    Yes
Number of months:
TIA known?
Did the event occurr > 5 years ago?   No    Yes
dysfunction?
Cerebrovascular Disease
Yes
No

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
When was the subject last being treated for endocarditis?
Please indicate the last known severity:
Yes Pulmonary valve insufficiency
No
Yes
No
Pulmonary valve stenosis
Yes
No
Alcohol/Drug Abuse
Is the subject a current smoker?   No     
Yes
When did the subject quit?
Myocarditis
Yes
No
Endocarditis
Yes
No
Smoking
Yes
No
Rheumatic fever
Yes
Does the subject have a history of:
No
Hyperlipidemia or Hypercholesterolemia
When was the subject last being treated for myocarditis?
Yes
No

Status
Visit Name
Blank CRF
Subevent#
Doc#
CRF Name
Subject ID
Study
Visit Date
Site
Has the subject required amputation of a limb due to arterial disease?
How many cardiac/heart surgeries has the subject previously had?
How many previous cardiovascular surgeries has the subject had?
PRIOR CARDIOVASCULAR SURGICAL INTERVENTIONS
MEDICAL HISTORY (Part 2)
Please specify the type of implant the subject has:
Is the date of the implant known?   No    
Yes
Date of implant:
No    Yes
Did the event occur > 5 years ago?
Is the approximate number of months since the implant known?
No    Yes
Approximately how many months ago was the subject implanted?
Limb Arteries
Yes
No
Thoracic Aorta
cardioverter defibrillator (ICD)?
Yes
No
Yes
No
Yes
What type of intervention was done on the carotids?
Please specify:
Yes
No
Carotid Arteries
No
Abdominal Aorta
Were surgical interventions performed on any of the following cardiovascular components?
Yes
No
Has the subject been implanted with a permanent pacemaker or an implantable
GLX_EXT_2010_03
Version A
Version A
MEDICAL_HISTORY_P2
BASELINE

Status
Visit Name
Blank CRF
Subevent#
Doc#
CRF Name
Subject ID
Study
Visit Date
Site
Other intervention on the coronary arteries
No    Yes
Please specify:
CABG
No    Yes
No
What type of interventions have been performed?
How many grafts were done?
Percutaneous transluminal coronary angioplasty (PTCA) /
Percutaneous coronary intervention (PCI)
Yes
Was a stent employed for any of the past PTCA / PCI procedures?
No   
Yes    Unknown
Yes
Please specify:
Were the following interventions performed?
Valvuloplasty
No    Yes
Valve Replacement
No    Yes
Other repair
No
Yes
No
Yes
No
Aortic Valve
Coronary Arteries
MEDICAL_HISTORY_P2
BASELINE
GLX_EXT_2010_03

Status
Visit Name
Blank CRF
Subevent#
Doc#
CRF Name
Subject ID
Study
Visit Date
Site
Yes
Valve replacement
No    Yes
Other repair
Were the following interventions performed?
No    Yes
Please specify:
Annuloplasty
No    Yes
Valvuloplasty
No
No    Yes
Other repair
No    Yes
Were the following interventions performed?
Please specify:
Valvuloplasty
No    Yes
Valve replacement
Valve replacement
Were the following interventions performed?
No    Yes
Other repair
No    Yes
Please specify:
Annuloplasty
No    Yes
Valvuloplasty
No    Yes
Yes
No
Pulmonary valve
Please specify the location of the intervention and the type of surgical procedure performed
Yes
Yes
No
No
Tricuspid valve
Other Cardiovascular Component
Yes
No
Mitral Valve
MEDICAL_HISTORY_P2
BASELINE
GLX_EXT_2010_03

Status
Visit Name
Blank CRF
Subevent#
Doc#
CRF Name
Subject ID
Study
Visit Date
Site
No   Yes
No   Yes
No   Yes
No   Yes
Please indicate the FEV1/FVC value
What type of treatment did the subject receive for this condition?
Chronic inhaled or oral bronchodilator therapy
Chronic steroid therapy
Oxygen or ventilation
Please specify:
Other treatment
Please specify the type:
Please specify:
Yes
No
Chronic obstructive pulmonary disease (COPD) / Chronic lung disease
No
30 days prior to the study procedure?
Please specify:
Yes
Has the subject received or will the subject receive chemotherapy within
Blood Diatheses
Yes
No
Does the subject currently have or has the subject ever had the following diseases?
NON-CARDIOVASCULAR RISK FACTORS
Yes
No
Cancer
Yes
No
Calcium Metabolic Disorders
MEDICAL_HISTORY_P2
BASELINE
GLX_EXT_2010_03

Status
Visit Name
Blank CRF
Subevent#
Doc#
CRF Name
Subject ID
Study
Visit Date
Site
No
No
Yes
Yes
Is the date when the subject was diagnosed known?
Date diagnosed
Is the approximate number of months since the subject was diagnosed known?
Approximately how many months ago was the subject diagnosed?
No     Yes
Was the subject diagnosed > 5 years ago?   No    Yes
Is the subject currently on dialysis?
Please indicate the type of diabetes:
Diet
Is the subject currently receiving the following treatments?
No    Yes
Oral
No    Yes
Insulin
No    Yes
Yes
No
Renal Failure/Insufficiency
Does the subject have severe impairment of mobility due to this condition?
No   
Yes
steroid therapy or chemotherapy within 30 days of the study procedure
Other disease which requires immunosuppressive therapy inhaled or systemic
Yes
No
Musculoskeletal Dysfunction
Yes
Yes
No
Obesity (BMI >=30)
Yes
No
No
Diabetes
Liver Disease
Yes
No
MEDICAL_HISTORY_P2
BASELINE
GLX_EXT_2010_03

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
If Yes, please fill out a Blood Data form (LABS)
/
Was information about the subject's current medications collected?
(Applicable for 2 and 4 year visit)
(DD/MMM/YYYY)
If No, a transthoracic echocardiogram (TTE) is not needed for this visit
Date of auscultation exam:
If Yes, please complete transthoracic echocardiogram (TTE)
Was an aortic murmur heard?
No
Yes
BPM
Blood pressure:
Weight:
Yes
No
ASSESSMENT
Was an auscultation performed?
Rev B
mmHg
lb
kg
(Required at Baseline and 1 Year only)
Diastolic
If Yes, please fill out a Quality of Life (QOL) form
Systolic
If Yes, please fill out a Medication form (MED)
NYHA Classification
If Yes, please fill out a Electrocardiogram form (ECG)
Yes
PLEASE PROVIDE THE FOLLOWING PHYSICAL ASSESSMENT PARAMETERS:
No
Was a blood test performed?
Yes
No
If Yes, please fill out a Echocardiogram form (ECHO (S))
What was the primary method of contact with the subject?
Was an electrocardiogram (ECG) performed?
Heart Rate:
Yes
No
Yes
Was a transthoracic echocardiogram (TTE) performed?
No
Yes
Was Quality of Life assessed?
No

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Yes
Yes
Pulmonary/Respiratory
No   Yes
Peripheral Vascular
No   Yes
Psychiatric
No   Yes
Muscular Skeletal/Dermatologic
Are the event(s) that occurred within the following AE classifications?
No   Yes
Blood and Lymphatic (Including ALL Bleeding complications)
Nonspecific or Unknown Body System
No
No   Yes
Yes
Cardiovascular - Arrhythmia
No
Yes
Yes
Cardiovascular - Embolic Event/Valve Thrombosis
Cardiovascular - Regurgitation
No   Yes
Cardiovascular - Misc
No   Yes
Cardiovascular - Stenosis
No
No
Yes
Device Dysfunction
No
Yes
Gastrointestinal/Hepatic
No   Yes
Genitourinary/Renal
No
Comments
Have any adverse events occurred that were not previously reported?
If Yes, please ensure an adverse event form has been completed for each event.
Not applicable at Baseline
No

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Yes
No
within 21 days?
Rev B
SURGERY DATA
Implanting surgeon:
Date of surgery:
Date of hospital admission:
No
Cardiopulmonary resuscitation <1hr prior to surgery
Yes
No
Acute renal failure  (anuria or oliguria <10 ml/hr)
Yes
No
On the day of surgery but prior to going under anesthesia, did the subject experience or require:
Aborted sudden death
Within 2 weeks prior to the surgical procedure:
Yes
PREOPERATIVE CONDITION
No
(DD/MMM/YYYY)
Cardiogenic shock
For Purposes of Risk Score Assessment, did a Myocardial Infarction (MI) occur
Yes
Another cardiac intervention <= 6 hours prior to scheduled surgery
No
(DD/MMM/YYYY)
Ventricular tachycardia
Yes
No
Ventricular fibrillation
Yes
No
Did the subject receive IV inotropic agents within 48 hours preceding surgery or
What is the likely cause of these symptoms?
Yes
No
Did the subject experience cardiac/chest pain or angina after hospital admission?
Was the observed arrhythmia considered Atrial fibrillation or Atrial flutter?    No  
Yes
Yes
No
Yes
No
Did the subject experience an arrhythmia?
Yes
Yes
No
No
Was the subject in congestive heart failure?
Inotropic support or IABP
Yes
No
Ventilation before arrival in anesthetic room
Yes
Please indicate the time interval when the last MI occurred:
was the administration of this medication documented as contraindicated?

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Please specify:
Other MIS approach
Right thoracotomy
Mini upper sternotomy
Full sternotomy
What surgical approach was used?
INTRA-OPERATIVE ETIOLOGY AND DIAGNOSIS
Please specify:
Please confirm the diagnosis for the current replacement:
Please specify:
Yes
No     
Other etiology
Yes
No     
Remote endocarditis
Yes
No     
Rheumatic
Yes
they can be discharged)
No     
Dystrophic calcification
Yes
No
Prosthetic valve dysfunction
Pure insufficiency
Degenerative
EMERGENCY (Operation before the beginning of the next working day after the decision made
Stenosis with insufficiency
SALVAGE (Requires cardiopulmonary resuscitation prior to induction of anesthesia)
Stenosis
URGENT (Not admitted for the operation, but requires surgery on the current admission before
ELECTIVE (Admission for operation; subject
's cardiac function is stable in the days/weeks prior
disease?
What is the urgency of the surgery being performed?
Were any of the following intraoperative diagnoses made concerning the etiology of the valve
to operate)
Other diagnosis
to the operation)

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Yes
Coronary arteries
No  
Yes
Annulus
No  
Yes
Leaflets
No  
Yes
Aortic wall
No
Was calcification observed in the following locations?
Yes
No
Yes
Vegetation
Yes
No
Yes
No
SURGICAL APPROACH AND ANNULUS PREPARATION
Myxomatous
Yes
No
Were the following concomitant procedures performed?
Is there evidence of the following conditions of the aortic valve, annulus, aortic wall, or coronary
Automatic Implanted Cardioverter Defibrillator (AICD) implant
Was Cardiac Resynchronization Technique (CRT) used?   No   Yes
No      
Leaflet perforation
Yes
No
Calcification
Leaflet fusion
Yes
No      
Permanent pacemaker implant
Was Cardiac Resynchronization Technique (CRT) used?   No    Yes
arteries?
How many grafts were done?
Yes
No
Coronary artery bypass grafting (CABG)
Please specify:
Yes
No      
Other disease condition

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
What was the type of defect repaired?
Yes
Was an intraaortic balloon pump (IABP) used in relation to this surgical procedure?
No
Please indicate the appendage
Right
Left
Occlusion / Removal of atrial appendage
Yes
Was the unplanned procedure a Ventricular Assist Device (VAD) insertion?    No   Yes
Why was this procedure necessary?
Were any unplanned procedures performed during this operation?
Yes
Please specify:
No      Aortic aneurysm/dissection repair
Yes
No      Other procedure
Yes
No
No
Yes
No      Atrial ablation
What type of ablation procedure was done?
Primarily epicardial
Primarily intracardiac
Septal myectomy
Yes
No      Atrial septal defect (ASD) repair
Amount of Annular / Aortic Root Debridement
When was the IABP inserted?
Yes
No

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
(If 
'2
' is selected, please fill out two (2) Device Performance forms)
** If Model 11000 is selected, please complete the following questions: **
1
2
(If 
'1
' is selected, please fill out one (1) Device Performance form)
On what attempt was the study valve implanted?
Was a post-implant echocardiogram performed?   
No   
Yes
What type of echocardiogram was done?
What was the severity of central regurgitation for the study valve?
What was the severity of paravalvular leak for the study valve?
Was observed regurgitation clinically acceptable?      No   
Yes
Please complete the following questions:
(HH:MM)
Time echocardiogram started:
(If selected, please complete *** Commercial Valve *** section below)
What valve was implanted?
(If selected, please fill out a Study Exit form)
*** If Commercial Valve is selected, please complete the following questions: ***
(mm)
(If 
'2
' is selected, please fill out two (2) Device Performance forms (PERF).
1
2
After which study valve attempt was a commercial valve implanted?
Why was a second attempt to implant the study valve not performed?
Please specify:
(If 
'1
' is selected, please fill out one (1) Device Performance form (PERF).
Manufacturer and Model:
(If selected, please complete **Model 11000** section below)
Please provide the following information about the commercial valve:
Valve size:
No valve implanted due to subject death
Commercial valve
Model 11000

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Yes
Cardiovascular - Embolic Event/Valve Thrombosis
No   
Yes
Cardiovascular - Misc
No
No
Yes
Yes
Device Dysfunction
Cardiovascular - Regurgitation
No
No
Yes
No
Cardiovascular - Stenosis
Yes
Gastrointestinal/Hepatic
No   
Yes
Genitourinary/Renal
No   
Yes
Pulmonary/Respiratory
No   
Yes
Peripheral Vascular
No   
Yes
Psychiatric
No   
Yes
Muscular Skeletal/Dermatologic
No   
Yes
Nonspecific or Unknown Body System
No   
Yes
Blood and Lymphatic (Including ALL Bleeding complications)
Are the event(s) that occurred within the following AE classifications?
No   
Yes
Cardiovascular - Arrhythmia
Yes
No
Did any adverse events occur during the surgery?
If Yes, please ensure an adverse event form has been completed for each event.

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
(HH:MM)
Please provide the times at which the following procedural steps were performed:
(HH:MM)
(HH:MM)
(HH:MM)
(HH:MM)
(HH:MM)
Comments
End Skin closure:
Start skin incision:
Yes
No
Was there a bleeding-related reoperation within the first 24 hours after surgery?
End ECC (Pump):
Remove cross clamp:
Start sizing:
Start cross clamp:
Start ECC (Pump):
(HH:MM)

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Please specify:
Please specify:
Failure type:
Failure type:
Please indicate the types of valve failures observed:
Failure type:
Failure type:
Please specify:
Please specify:
How was the valve positioned?
What type of sizer was used?
Please specify:
What was the barrel size of the valve sizer?
What suture technique was used to secure the valve?
DEVICE PERFORMANCE
mm
Please provide the following information about the study valve:
Please specify:
Serial Number:
Rev B
Did the study valve perform as intended?
What study valve implant attempt was being performed?
No
Yes
Valve size:

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
DEVICE TECHNICAL SUCCESS:
Did the subject leave the operating room with the study valve in place for this attempt?
No
Yes
No
Was the heart restarted after this implant attempt?
Please specify:
Why did the implant attempt fail?
Yes
VALVE IMPLANT TIMES:
Start the study procedure (first stitch):
(HH:MM:SS)
Complete the study procedure (last stitch tied down on the valve):
(HH:MM:SS)
Comments

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
When was the transthoracic echocardiogram (TTE) performed?
Duration of time in the Intermediate Care / High Dependency Unit
and
Version A
DISCHARGE
Duration of time in the Intensive Care Unit (ICU)
and
(DD/MMM/YYYY)
Duration of time in the General Ward
valve procedure
and   Hours
Days
Hours
Days
Please provide the following information about the subject's hospitalization after the study
Hours
Days
Where was the subject discharged to?
Date of discharge
DISCHARGE
DISCHARGE
GLX_EXT_2010_03

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Rev B
Cardiovascular - Embolic Event/Valve Thrombosis
Genitourinary/Renal
Cardiovascular - Misc
Pulmonary/Respiratory
Cardiovascular - Stenosis
Blood and Lymphatic (Including ALL Bleeding complications)
Cardiovascular - Arrhythmia
Device Dysfunction
Timing of Event Onset
Site Awareness Date
Event Onset Date
Gastrointestinal/Hepatic
Nonspecific or Unknown Body System
(DD/MMM/YYYY)
Psychiatric
Muscular Skeletal/ Dermatologic
Peripheral Vascular
ADVERSE EVENT
Cardiovascular - Regurgitation
Please select the AE Classification:
(DD/MMM/YYYY)

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
(DD/MMM/YYYY)
Date of Re-operation:
(DD/MMM/YYYY)
Date of Clinical Exam:
(DD/MMM/YYYY)
Date AE first observed:
(DD/MMM/YYYY)
Date of Angiogram:
(DD/MMM/YYYY)
Date of MRI:
Electrocardiogram (ECG)
Please, specify:
Event Summary/Comments
Clinical Exam
Yes
No
Re-operation
Echocardiogram
Observation
Yes
No
Autopsy
Yes
No
Yes
No
MRI
Yes
No
Angiogram
Yes
No
Yes
No
Lab finding
Method of Detection
Yes
No
Other method
Yes
No
Yes
No

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Yes
No     Yes
Please indicate what type(s) of medication contributed to this event:
Was this medication prescribed due to study valve implant?
Anticoagulant medication
No     Yes
Aspirin
No     Yes
Other antiplatelet medication
No
Other antithrombotic medication
No     Yes
Please, specify:
No     Yes
Resulted in death
No     Yes
No     Yes
Please indicate all conditions of a SAE that apply:
Resulted in a medical intervention to prevent permanent impairment
to body structure or function
No     Yes Resulted in life-threatening illness/injury
No     Yes Resulted in permanent impairment
No     Yes Resulted in hospitalization or prolongation or current hospitalization
No     Yes
body structure or function
Resulted in surgical intervention to prevent permanent impairment to
No     Yes
defect
Resulted in fetal distress or death, congenital abnormality or birth
Did non-antithrombotic medication contribute to this event?
Did antithrombotic medication contribute to this event?
Yes
No
Please, specify:
What was the underlying condition?
No     Yes
Yes
Causality: Is this event related to any of the following?
No
Indeterminate
Yes
No
Indeterminate
Yes
No
Indeterminate
Yes
No
Indeterminate
Yes
No
Underlying Condition
Deficiency in Instructions
User Error
Study Valve
Surgical Procedure
Is this a serious adverse event (SAE)?
Indeterminate

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
(DD/MMM/YYYY)
Date resolved:
Cardioversion
No     Yes
Transfusion
Prolonged hospitalization
No     Yes
Re-hospitalization required
No     Yes
Medication given
No     Yes
Other intervention
No     Yes
Permanent Pacemaker implanted
No     Yes
No     Yes
No     Yes
No     Yes
Please indicate whether the following interventions were needed:
(DD/MMM/YYYY)
Hospital admission date:
No     Yes
Discharge date:
(DD/MMM/YYYY)
Was the subject discharged from the hospital?
(not planned prior to AVR)
Surgical intervention - reoperation on the study valve
Surgical intervention - not reoperation on the study valve
What type of medication was given?
(DD/MMM/YYYY)
Date of surgical intervention:
(DD/MMM/YYYY)
Date of pacemaker implant:
Please, specify:
No     Yes
No     Yes
(DD/MMM/YYYY)
Date of surgical intervention:
Was this adverse event the primary cause of
reoperation on the study valve?
Did the reoperation result in
removal/replacement of the study valve?
Was any intervention taken to treat this adverse event?
Is this an unanticipated device related adverse effect (UDAE)?
Indicate the outcome of the event:
Yes
No
Yes
No

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Date Blood Drawn:
White Blood Cells (WBC)
Red Blood Cells (RBC)
Hemoglobin:
Hematocrit:
Platelet Count:
Plasma Free Hemoglobin:
Coagulation Profile
Rev B
BLOOD DATA (LABS)
(DD/MMM/YYYY)
Is this value within normal range?      No
Yes
Was the result clinically significant?      No
Yes    Not Applicable
No
Not Applicable
Is this value within normal range?
Yes
Yes
No
Was the result clinically significant?
Yes
No
Is this value within normal range?
Not Applicable
Yes
No
Was the result clinically significant?
Not Applicable
Yes
No
Is this value within normal range?
Was the result clinically significant?      No     Yes
Not Applicable
Yes
Is this value within normal range?      No
Was the result clinically significant?      No     Yes
Not Applicable
Yes
No
Is this value within normal range?
Was the result clinically significant?      No     Yes
INR:
PTT:
PT (seconds):

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Version A
MEDICATIONS
No     Yes
Please indicate if the subject is taking anticoagulants:
No     Yes
Please indicate if the subject is taking antiplatelets:
Warfarin - Coumadin (or derivatives)
No     Yes
Other anticoagulant
No     Yes
Please specify:
Heparin
Please indicate the type of anticoagulant(s):
No     Yes
Low Molecular Weight Heparin
No     Yes
Please indicate the type of antiplatelet(s):
Dipyridamole - Persantine
No     Yes
Aspirin - Ecotrin or Entrophen
No     Yes
Ticlopidine
No     Yes
Clopidogrel-Plavix
No     Yes
Other antiplatelet
No     Yes
Please specify:
Yes
No
Antithrombotics (Thrombolytics)
Date Information Collected:
(DD/MMM/YYYY)
Please indicate what type of medications the subject is currently taking:
GLX_EXT_2010_03
MEDICATIONS
BASELINE

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Diuretic
Yes
Please indicate if the subject is taking the following antiarrhythmics:
Other (Sodium/Potassium channel blockers, i.e. Amiodarone)
No     Yes
Beta Blockers (Propanolol, Esmolol)
No     Yes
No
Yes
No
Calcium Blocker
Yes
No
Steroids
Yes
No
Nitrates
Antiarrhythmics
Yes
No
Yes
ACE or ARB Inhibitors
No
Lipid Lowering
Yes
No
MEDICATIONS
BASELINE
GLX_EXT_2010_03

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
AV block
Bundle branch block / Intraventricular block
Please indicate if evidence of the following conduction disturbances was found during
No
Please specify:
Yes
Atrial fibrillation / Supraventricular tachycardia
Other conduction disturbance
Yes
No
Please indicate branch:
Left   No   
Yes
Right  No   
Yes
No
Other cardiac arrhythmia
Please indicate the episodic pattern:
Yes
(DD/MMM/YYYY)
Sinus bradycardia
Yes
Version A
No
No
Sinus tachycardia
Tachycardia-bradycardia syndrome
Yes
Yes
Yes
No
No
No
ELECTROCARDIOGRAM (ECG) EXAM
the ECG exam:
Please specify the type:
Yes
No
Sinus rhythm with no abnormalities
Ventricular tachycardia
Please specify:
Yes
Yes
Is the subject implanted with a permanent pacemaker?
Yes
No
No
Date of electrocardiogram (ECG) exam:
Please indicate degree:
No
Yes
Dose the subject have an implantable cardioverter defibrillator (ICD/AICD)?
Atrial flutter
Please indicate the episodic pattern:
No
Yes
Please indicate if the following cardiac rhythms were observed during the ECG:
GLX_EXT_2010_03
ECG
BASELINE

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
<< Continued on Next Page >>
Pain/Discomfort
Anxiety/Depression
Overall State
Date of assessment
Indicate which statement the subject marked on the survey:
EQ-5D Questionnaire
(Indicate how the subject rated their overall health today)
Mobility
(DD/MMM/YYYY)
Self-care
Usual Activities (e.g. work, study, housework, family or leisure activities)
QUALITY OF LIFE (QOL) ASSESSMENT
Comments:
Yes
No
Was an EQ-5D questionnaire completed?
QUALITY OF LIFE
Revision A

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
feeling.  How much of the time during the past 4 weeks.....
1. In general, would you say your health is:
a. Accomplished less than you would like
b. Were limited in the kind of work or other activities
(DD/MMM/YYYY)
weeks. For each question, please give one answer that comes closest to the way you have been
a. Accomplished less than you would like
3. During the past 4 weeks, how much of the time have you had any of the following problems
b. Did work or activities less carefully than usual?
a. Have you felt calm and peaceful?
b. Did you have a lot of energy?
5. During the past 4 weeks, how much did pain interfere with your normal work (including both work
7. During the past 4 weeks, how much of the time has your physical health or emotional problems
2. The following questions are about activities you might do during a typical day. Does your health
depressed or anxious)?
c. Have you felt downhearted and depressed?
outside the home and housework)?
Indicate which statement the subject marked on the survey:
with your work or other regular daily activities as a result of your physical health?
SF-12 v2 Questionnaire
your work or other regular daily activities as a result of any emotional problems (such as feeling
4. During the past 4 weeks, how much of the time have you had any of the following problems with
now limit you in these activities? If so, how much?
6. These questions are about how you feel and how things have been with you during the past 4
interfered with your social activities (like visiting friends, relatives, etc.)?
Date of assessment
b. Climbing several flights of stairs
a. Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling,
or playing golf.
Comments
Yes
No
Was an SF-12-v2 questionnaire completed?

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Rev B
Please specify:
******* NOT A CRF *******
Systolic
Please specify:
Delivery Method:
Date echocardiographs were delivered to the Core Lab:
Cardiac Rhythm:
/ Diastolic
Blood Pressure (mmHg):
Shipment Tracking Number:
Heart Rate (BPM):
Weight:
Please provide the following physical assessment parameters:
ECHO Equipment used:
Name of the Echocardiographer:
Date of ECHO Exam:
SITE ECHO TRACKING FORM
lb
kg

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Please indicate the results of the LVOT assessment
Peak Velocity
Mean Gradient
VTI
Please indicate the results of the aortic valve assessment
Peak Velocity
Peak Gradient
Mean Gradient
VTI
What was the annulus size (cm)?
What was the AV area (cm^2)?
Please indicate the AR Severity:
Peak Gradient
Please indicate the MR Severity:
What was the LVEF?
What was the range of the LVEF?
Max Value:
Min Value:
Please indicate the severity of paravalvular leak (PVL):
What was the assessment of RV function?
Please indicate the transvalvular leak severity:
What method was used to determine the LVEF?
Yes
No
Did the echocardiographer assess the aortic valve?

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Height
Unit
Rev B
Weight
Unit
Does the Echo indicate the subject has the following cardiac rhythm / conducting
Normal Sinus Rhythm
Atrial Fibrillation
Atrial Flutter
Ventricular Tachycardia
Ventricular Fibrillation
Indeterminate
No    Yes   Indeterminate
AV Block
No
Please indicate the degree:
Bundle Branch Block
Please indicate branch:
Yes   Indeterminate
ECHO CORE LAB RESULTS (Baseline)
Date of ECHO Exam
system disturbances?
Blood pressure (mmHg)
Yes
No
Yes
No
Was the readability issue resolved?
Was a request sent to the site to resend the images?
Date readability issue resolved:
Date of resend request:
No    Yes   Indeterminate
No   
Yes   Indeterminate
No
No
Date ECHO Received by Core Lab
Date of Readability Assessment
Please indicate whether or not the images were readable:
Yes
Yes
Was the ECHO Assessed by the Core Lab?
Indeterminate
Physical Assessment
No    Yes   Indeterminate
No
Body Surface Area (BSA)
Heart Rate (BPM)
Yes
Systolic
/ Diastolic

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
No    Yes
No   
Yes
No
Aortic Valve Assessment: Stenosis
Please indicate the level of Aortic Stenosis:
LV Structure / Regional Function
LV aneurysm
Please specify the location:
Yes
No   
Yes
Wall motion abnormality
Please specify:
Cavity dilation
Apical and/or left atrial thrombi
Other abnormality
Please specify:
Global LV Structure / Function
What method of calculation was used for LV function assessment?
LVEDV (ml):
LVESV (ml):
No   
Yes
LVEF (%):
LV Dimensions
Septal thickness (end-diastolic) (cm):
Posterior wall thickness (end-diastolic) (cm):
LV end-diastolic dimension (cm):
LV end-systolic dimension (cm):
LV Mass (g):
BSA corrected LV mass (g/m^2):
Please indicate if any of the following abnormalities were observed:

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
TVI (AO) (cm):
Performance Index:
Aortic Dimensions
LVOT Diameter (cm):
Aortic Valve Assessment: Measurements
VpeakAO (m/sec):
Peak systolic gradient of AV (by continuous wave) (mmHg):
Mean systolic gradient of AV (by continuous wave) (mmHg):
TVI (LVOT) (cm):
Maximum V(LVOT) (m/sec):
Mean V(LVOT) (m/sec):
Stroke Volume (LVOT Derived) (ml):
Transvalvular flow (ml/s):
Cardiac Output (LVOT derived) (L/min):
Cardiac Index (L/min/m^2):
Aortic EOA (continuity equation) (cm^2):
Aortic EOA Index (cm^2/m^2):
Aortic Valve Assessment: Regurgitation
Please identify all the methods of calculation used:
Color Doppler
Regurgitant Fraction
No    Yes
No    Yes
Proximal Convergent Flow
Continuous wave doppler (Pressure half-time)
Aortic Flow Reversal
No    Yes
No    Yes
No
Aortic annulus (cm):
Aortic root diameter (cm):
STJ diameter (cm):
Yes

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
PLAX
No   
Yes
PSAX
Please indicate the image views of the jets:
Please indicate the location of the jets:
Please specify:
Please indicate the Number of Jets:
No   
Yes
A5C
No   
Yes
A3C
No   
Yes
No    Yes
Please indicate the total regurgitation severity
Please indicate the level of Pericardial Effusion:
Please specify:
RV Function
Please indicate overall assessment of the Right Ventricle:
Pericardial Effusion
Please indicate the Paravalvular Leak Severity
Please indicate the Transvalvular Leak Severity:
Non-Aortic Valve Regurgitation
Please indicate the level of Tricuspid Valve Regurgitation:
Please indicate the level of Mitral Valve Regurgitation:
Was there Mitral Valve Stenosis?

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
ECHO Quality
Please indicate the overall Quality of the ECHOs:
Comments

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Weight
Unit
Rev B
Was a request sent to the site to resend the images?
Was the readability issue resolved?  
No    Yes
No    Yes
Date of resend request:
Date readability issue resolved:
No
Indeterminate
Yes
No
Blood pressure (mmHg)
system disturbances?
Date of ECHO Exam
ECHO CORE LAB RESULTS
Indeterminate
Yes
Please indicate the branch:
Bundle Branch Block
Please indicate the degree:
No
AV Block
Indeterminate
Yes
No
Indeterminate
Ventricular Fibrillation
Ventricular Tachycardia
Atrial Flutter
Atrial Fibrillation
Normal Sinus Rhythm
Does the Echo indicate the subject has the following cardiac rhythm / conducting
/ Diastolic
Systolic
Yes
Heart Rate (BPM)
Body Surface Area (BSA)
No
Indeterminate
Yes
No
Unit
Height
Physical Assessment
Indeterminate
Was the ECHO Assessed by the Core Lab?
Yes
Yes
Please indicate whether or not the images were readable:
Date of Readability Assessment
Date ECHO Received by Core Lab
No
No
Indeterminate
Yes

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Please indicate if any of the following abnormalities were observed:
Yes
No
Please specify the location:
LV aneurysm
LV Structure / Regional Function
Please indicate the level of Aortic Stenosis:
Aortic Valve Assessment: Stenosis
Please specify:
Yes
No
Wall motion abnormality
Yes
No
Please specify:
Yes
Yes
No
Other abnormality
No
Apical and/or left atrial thrombi
Cavity dilation
BSA corrected LV mass (g/m^2):
LV Mass (g):
LV end-systolic dimension (cm):
LV end-diastolic dimension (cm):
Posterior wall thickness (end-diastolic) (cm):
Septal thickness (end-diastolic) (cm):
LV Dimensions
LVEF (%):
LVESV (ml):
LVEDV (ml):
What method of calculation was used for LV function assessment?
Global LV Structure / Function

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
STJ diameter (cm):
Aortic root diameter (cm):
Aortic annulus (cm):
LVOT Diameter (cm):
Aortic Dimensions
Aortic EOA Index (cm^2/m^2):
Aortic EOA (continuity equation) (cm^2):
No
Continuous wave doppler (Pressure half-time)
No
No
Yes
Cardiac Index (L/min/m^2):
Cardiac Output (LVOT derived) (L/min):
Transvalvular flow (ml/s):
Proximal Convergent Flow
Stroke Volume (LVOT Derived) (ml):
No
Regurgitant Fraction
Color Doppler
Please identify all the methods of calculation used:
Aortic Valve Assessment: Regurgitation
Mean V(LVOT) (m/sec):
Maximum V(LVOT) (m/sec):
TVI (LVOT) (cm):
Mean systolic gradient of AV (by continuous wave) (mmHg):
Peak systolic gradient of AV (by continuous wave) (mmHg):
VpeakAO (m/sec):
Aortic Valve Assessment: Measurements
Yes
Yes
Yes
Yes
Aortic Flow Reversal  
No
TVI (AO) (cm):
Performance Index :

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Indeterminate
Yes
No
Ring Abscess
Indeterminate
Yes
No
Vegetation
Indeterminate
Yes
No
Thrombus
Indeterminate
Yes
No
Pannus Formation
Indeterminate
Yes
No
Aortic Valve Morphology
Cusp Perforation
Please indicate the degree of calcification:
Please indicate the leaflet thickening:
Please indicate the leaflet mobility:
Please indicate whether the following morphologies were observed:
Please indicate the Transvalvular Leak Severity:
Please indicate the Number of Jets:
Please specify:
Please indicate the location of the jets:
Please indicate the image views of the jets:
PLAX
Yes
No
PSAX
Yes
No
A5C
Yes
No
Yes
No
A3C
Please indicate the total regurgitation severity:
Indeterminate
Yes
No
Please indicate the Paravalvular Leak Severity:
Pseudoaneurysm

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Please indicate the level of Tricuspid Valve Regurgitation:
Non-Aortic Valve Regurgitation
Please indicate the overall Quality of the ECHOs:
Comments
ECHO Quality
RV Function
Please indicate overall assessment of the Right Ventricle:
Please specify:
Please indicate the level of Pericardial Effusion:
Pericardial Effusion
Please indicate the level of Mitral Valve Regurgitation:

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Please specify:
Please specify:
Please describe the type of deviation
Please indicate the corrective action taken to prevent further deviations
What was the reason for the deviation?
Please select type of deviation
Date of Deviation
(DD/MMM/YYYY)
PROTOCOL DEVIATION (Baseline)
Rev B

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Please describe the type of deviation
Please indicate the corrective action taken to prevent further deviations
What was the reason for the deviation?
Please select type of deviation
Date of Deviation
Please specify
Please specify
PROTOCOL DEVIATION (Discharge)
(DD/MMM/YYYY)
Version A

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Please describe the type of deviation
Please indicate the corrective action taken to prevent further deviations
What was the reason for the deviation?
Please select type of deviation
Date of Deviation
Please specify
Please specify
(DD/MMM/YYYY)
Version A
PROTOCOL DEVIATION (Procedure)

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Was subject
's family or friends contacted?
Please describe the type of deviation
Please indicate the corrective action taken to prevent further deviations
Please select type of deviation
Date of Deviation
What was the reason for the deviation?
Please specify
Please specify
Yes
Yes
No
No
Was the subject alive based on the contact?
Version A
Can you confirm through any other sources if the subject is alive?
(DD/MMM/YYYY)
Please indicate the date when the last attempt to contact the subject was made
PROTOCOL DEVIATION (3 Month)
(DD/MMM/YYYY)
(DD/MMM/YYYY)
Date of Contact
Yes
No

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Please specify:
Please specify:
Please describe the type of deviation
No
Was subject
's family or friends contacted?
Yes
(DD/MMM/YYYY)
No   
Yes
Please indicate the date when the last attempt to contact the subject was made
Can you confirm through any other sources if the subject is alive?
Yes
No
(DD/MMM/YYYY)
Date of Contact
Was the subject alive based on the contact?
What was the reason for the deviation?
Please select type of deviation
Date of Deviation
Please indicate the corrective action taken to prevent further deviations
(DD/MMM/YYYY)
Rev B
PROTOCOL DEVIATION (1 Year)

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Was subject
's family or friends contacted?
Please describe the type of deviation
Please indicate the corrective action taken to prevent further deviations
What was the reason for the deviation?
Please select type of deviation
Date of Deviation
Please specify
Please specify
Version A
(DD/MMM/YYYY)
(DD/MMM/YYYY)
Yes
No
No   Yes
Yes
(DD/MMM/YYYY)
PROTOCOL DEVIATION (2 Year)
Date of Contact
No
Please indicate the date when the last attempt to contact the subject was made
Can you confirm through any other sources if the subject is alive?
Was the subject alive based on the contact?

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Please specify
Please describe the type of deviation
Was subject
's family or friends contacted?
Please indicate the corrective action taken to prevent further deviations
What was the reason for the deviation?
Please select type of deviation
Date of Deviation
Please specify
No  Yes
(DD/MMM/YYYY)
(DD/MMM/YYYY)
Please indicate the date when the last attempt to contact the subject was made
No
Version A
PROTOCOL DEVIATION (3 Year)
Date of Contact
(DD/MMM/YYYY)
Yes
Was the subject alive based on the contact?
Can you confirm through any other sources if the subject is alive?
Yes
No

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Was subject
's family or friends contacted?
Please describe the type of deviation
Please indicate the corrective action taken to prevent further deviations
Please select type of deviation
Date of Deviation
What was the reason for the deviation?
Please specify
Please specify
Please indicate the date when the last attempt to contact the subject was made
(DD/MMM/YYYY)
Yes
(DD/MMM/YYYY)
Yes
Can you confirm through any other sources if the subject is alive?    
No
Was the subject alive based on the contact?
Yes
PROTOCOL DEVIATION (4 Year)
(DD/MMM/YYYY)
No
Date of Contact
Version A
No

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Please describe the type of deviation
Was subject
's family or friends contacted?
Please indicate the corrective action taken to prevent further deviations
Please select type of deviation
What was the reason for the deviation?
Date of Deviation
Please specify
Please specify
Date of Contact
Version A
No
Please indicate the date when the last attempt to contact the subject was made
Yes
Can you confirm through any other sources if the subject is alive?
Was the subject alive based on the contact?
Yes
(DD/MMM/YYYY)
(DD/MMM/YYYY)
(DD/MMM/YYYY)
Yes
No
PROTOCOL DEVIATION (5 Year)
No

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Please describe the type of deviation
Please indicate the corrective action taken to prevent further deviations
What was the reason for the deviation?
Please select type of deviation
Date of Deviation
Please specify
Please specify
PROTOCOL DEVIATION (Miscellaneous)
(DD/MMM/YYYY)
Version A

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Please describe the type of deviation
Please indicate the corrective action taken to prevent further deviations
What was the reason for the deviation?
Please select type of deviation
Date of Deviation
Please specify
Please specify
(DD/MMM/YYYY)
Version A
PROTOCOL DEVIATION (Adverse Event)

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
When was the device explanted?
Was information collected about the explant procedure?      No   
Yes
What was the surgical approach used for the explant procedure?
What type of aortotomy was performed?
Were study valve leaflets removed?
(Enter Type or Not Available)
No   
Yes   
Not Available
Was study valve sewing ring removed?     No   
Yes   
Not Available
Ease of study valve explant (Rate ease on a scale of 1-5, 5 being the best)
1   
2   3   4   5   N/A
Additional comments:
Was a replacement valve implanted?     
No   
Yes
Please provide the following information about the replacement valve:
Manufacturer and model:
Size (mm):
Version A
Please indicate the type of procedure that was performed:
Yes
If Valve-in-valve replacement or Other  is the type of procedure that was performed,
No
Did the surgical procedure occur at the investigational center?
Date of the study valve removal / replacement:
REOP_EXP
EXPLANT
please answer questions at the bottom of the next page
(DD/MMM/YYYY)
GLX_EXT_2010_03
REOPERATION
AE

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Was information collected about the appearance of the valve prior to or immediately following
No    Yes
Dehiscence
Thrombus
No
No
Yes
Other observations
Yes
Vegetation
No    Yes
Suture interference
Please indicate whether the following conditions were observed:
No    Yes
Calcification
No    Yes
Fibrosis
Please provide the following information about the replacement valve:
Please specify:
Size (mm):
Manufacturer and model:
RGA #
Yes
No
Was the explanted study valve returned?
Please specify:
Not Available
Yes
OTHER
No
Did excision of the study valve require or result in structural changes?
explant?
VALVE-IN-VALVE REPLACEMENT
Yes
No
REOPERATION
AE
GLX_EXT_2010_03

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
(DD/MMM/YYYY)
No   Yes
Cause of Death:
Date reported to the sponsor:
Days:    
and Hours:
Duration of time in the General Ward
Days:
Duration of time in the Intermediate Care / High Dependency Unit
and Hours:
Please provide the following information about the subject's hospitalization
Days:    
and Hours:
after the study valve procedure
Duration of time in the Intensive Care Unit (ICU)
(DD/MMM/YYYY)
(DD/MMM/YYYY)
Was an autopsy performed?
Date of Death:
No
Did the subject die intraoperatively during the study procedure?
Yes
(DD/MMM/YYYY)
Date of autopsy:
No   Yes
Removal/Replacement form (REOP_EXP)
If Yes, Please fill out the Study Valve
Was a study valve removed at autopsy?
No   Yes
Did the subject die prior to discharge from the hospital after the study procedure?
Please indicate when the subject withdrew:
Please indicate the reason for withdrawal:
Version A
Please specify:
Please indicate the reason for study exit:
Date of Study Exit:
STUDY EXIT
STUDY EXIT
STUDY_EXIT
GLX_EXT_2010_03

Subevent#
Visit Name
Blank CRF
Site
Status
Study
Visit Date
CRF Name
Subject ID
Doc#
Comments:
GLX_EXT_2010_03
STUDY EXIT
STUDY_EXIT

Edwards Pericardial Aortic Bioprosthesis, Model 11000 
Clinical Trial Number: 2010‐03 
 
Revision C: 8 MAY 2012 
Confidential
Page 38of 42
 
15.4 PROTOCOL DEVIATION CODES 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Edwards Pericardial Aortic Bioprosthesis, Model 11000    
Clinical Trial Number: 2010-03 
 
 
CONFIDENTIAL AND PROPRIETATARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences LLC 
 
Revision C: 8 MAY 2012 
 
 
        
 
 
PROTOCOL DEVIATION CODES 
SUBJECT SCREENING 
1.01  SUBJECT DID NOT MEET INCLUSION CRITERION 
1.02  SUBJECT MET EXCLUSION CRITERION 
1.03  DATE OF INFORMED CONSENT IS AFTER DATE OF STUDY ENROLLMENT 
1.04  INFORMED CONSENT WAS IMPROPERLY OBTAINED 
1.05  PERSON OBTAINING INFORMED CONSENT DID NOT SIGN/DATE THE 
CONSENT FORM 
1.06  OTHER SCREENING DEVIATION 
 
BASELINE 
2.01    BASELINE ECHOCARDIOGRAM NOT DONE 
2.02   BASELINE ECHOCARDIOGRAM DONE > 30 DAYS PRIOR IMPLANT DATE 
2.03   BASELINE BLOOD NOT DONE 
2.04   BASELINE BLOOD DONE > 30 DAYS BEFORE IMPLANT 
2.05   BASELINE BLOOD INCOMPLETE 
2.06    BASELINE COAGULATION PROFILE NOT DONE 
2.07   BASELINE COAGULATION PROFILE DONE > 30 DAYS BEFORE IMPLANT 
2.08   BASELINE NYHA NOT DONE 
2.09   BASELINE ELECTROCARDIOGRAM NOT DONE 
2.10   BASELINE ELECTROCARDIOGRAM DONE > 30 DAYS BEFORE IMPLANT 
2.11    BASELINE EQ-5D NOT DONE 
2.12  BASELINE SF-12 NOT DONE 
2.12   BASELINE PHYSICAL ASSESSMENT / VITAL SIGNS NOT DONE 
2.13   PREGNACY TEST NOT DONE 
2.14   MEDICAL HISTORY NOT COLLECTED 
2.15   OTHER BASELINE DEVIATION 
 
IMPLANT SURGERY 
3.01    IMPLANTING SURGEON IS NOT ON APPROVED LIST 
3.02   PROCEDURE DIAGNOSIS NOT DONE 
3.03   INCORRECT SIZER USED 
3.04   SKIN INCISION TIME NOT RECORDED 
3.05   START TIME OF ECC (PUMP) NOT RECORDED 
3.06   START CROSS CLAMP TIME NOT RECORDED 
3.07   START OF SIZING TIME NOT RECORDED 
3.08    REMOVAL CROSS CLAMP TIME NOT RECORDED 
3.09   END ECC (PUMP) TIME NOT RECORDED 
3.10   SKIN CLOSURE TIME NOT RECORDED 
3.11   UNAPPROVED CONCOMITANT PROCEDURE PERFORMED 
3.12   VALVE SERIAL NUMBER NOT RECORDED 
3.13   MORE THAN 2 STUDY VALVES ATTEMPTED TO BE IMPLANTED 
3.14   TIME FIST STITCH PLACED ON THE VALVE  NOT RECORDED 
3.15   COMPLETION TIME OF STUDY PROCEDURE (LAST STITCH TIED DOWN 
ON THE VALVE) NOT RECORDED 
3.16    POST-IMPLANT ECHOCARDIOGRAM NOT DONE 
3.17    POST-IMPLANT ECHOCARDIOGRAM NOT DONE WITHIN 1 HOUR OF 
REMOVING THE CROSS-CLAMP 
3.18   OTHER PROCEDURE DEVIATION 
 
DISCHARGE 
4.01   DISCHARGE OR 10-DAY ECHOCARDIOGRAM NOT DONE 
4.02   DISCHARGE OR 10-DAY ECHOCARDIOGRAM DONE > 10 DAYS POST 
IMPLANT DATE 
4.03   DISCHARGE PHYSICAL ASSESSMENT / VITAL SIGNS NOT DONE 
4.04   DISCHARGE ELECTROCARDIOGRAM NOT DONE 
4.05   DISCHARGE COAGULATION PROFILE NOT DONE 
4.06   DISCHARGE MEDICATIONS NOT ASSESSED 
4.07   OTHER DISCHARGE DEVIATION 
 
 
3 MONTHS 
6.01    3 MONTHS -  SUBJECT NOT CONTACTED 
6.02    3 MONTHS -  ASSESSMENT NOT DONE WITHIN FOLLOW-UP WINDOW 
6.03    3 MONTHS -  PHYSICAL ASSESSMENT / VITAL SIGNS NOT DONE 
6.04    3 MONTHS -  NYHA NOT DONE 
6.05    3 MONTHS -  ELECTROCARDIOGRAM NOT DONE 
6.06    3 MONTHS -  ELECTROCARDIOGRAM NOT DONE WITHIN FOLLOW-UP 
WINDOW 
6.07    3 MONTHS -  ECHOCARDIOGRAM NOT DONE 
6.08    3 MONTHS -  ECHOCARDIOGRAM NOT DONE WITHIN FOLLOW-UP 
WINDOW 
6.09    3 MONTHS -  BLOOD NOT DONE 
6.10    3 MONTHS -  BLOOD INCOMPLETE 
6.11    3 MONTHS -  COAGULATION PROFILE NOT DONE (ONLY REQUIRED FOR 
PATIENTS ON ANTICOAGULANT THERAPY) 
6.12    3 MONTHS -  BLOOD NOT DONE WITHIN FOLLOW-UP WINDOW 
6.13    3 MONTHS -  MEDICATIONS NOT ASSESSED 
6.14    3 MONTHS -  MEDICATIONS NOT ASSESSED WITHIN FOLLOW-UP 
WINDOW 
6.15    3 MONTHS -  OTHER DEVIATION 

Edwards Pericardial Aortic Bioprosthesis, Model 11000    
Clinical Trial Number: 2010-03 
 
 
CONFIDENTIAL AND PROPRIETATARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences LLC 
 
Revision C: 8 MAY 2012 
 
 
        
 
 
 
1-YEAR 
8.01    1 YEAR - SUBJECT NOT CONTACTED 
8.02    1 YEAR - ASSESSMENT NOT DONE WITHIN FOLLOW-UP WINDOW 
8.03    1 YEAR - PHYSICAL ASSESSMENT / VITAL SIGNS NOT DONE 
8.04    1 YEAR - NYHA NOT DONE 
8.05    1 YEAR - ELECTROCARDIOGRAM NOT DONE 
8.06    1 YEAR - ELECTROCARDIOGRAM NOT DONE WITHIN FOLLOW-UP 
WINDOW 
8.07    1 YEAR - ECHOCARDIOGRAM NOT DONE 
8.08    1 YEAR - ECHOCARDIOGRAM NOT DONE WITHIN FOLLOW-UP WINDOW 
8.09    1 YEAR - BLOOD NOT DONE 
8.10    1 YEAR - BLOOD INCOMPLETE 
8.11    1 YEAR - COAGULATION PROFILE NOT DONE (ONLY REQUIRED FOR 
PATIENTS ON ANTICOAGULANT THERAPY) 
8.12   1 YEAR - BLOOD NOT DONE WITHIN FOLLOW-UP WINDOW 
8.13   1 YEAR - MEDICATIONS NOT ASSESSED 
8.14   1 YEAR - MEDICATIONS NOT ASSESSED WITHIN FOLLOW-UP WINDOW 
8.15   1 YEAR – EQ-5D NOT DONE 
8.16  1 YEAR – SF-12 NOT DONE 
8.17   1 YEAR - OTHER DEVIATION 
 
2 YEAR 
9.01    2 YEAR - SUBJECT NOT CONTACTED 
9.02    2 YEAR - ASSESSMENT NOT DONE WITHIN FOLLOW-UP WINDOW 
9.03    2 YEAR - PHYSICAL ASSESSMENT / VITAL SIGNS NOT DONE 
9.04    2 YEAR - NYHA NOT DONE 
9.05    2 YEAR - ELECTROCARDIOGRAM NOT DONE 
9.06   2 YEAR - ELECTROCARDIOGRAM NOT DONE WITHIN FOLLOW-UP 
WINDOW 
9.07  2 YEAR – AUSCULTATION NOT DONE 
9.08   2 YEAR - ECHOCARDIOGRAM NOT DONE (AUSCULTATION INDICATED 
AORTIC MURMUR) 
9.09   2 YEAR - ECHOCARDIOGRAM NOT DONE WITHIN FOLLOW-UP WINDOW 
(AUSCULTATION INDICATED AORTIC MURMUR) 
9.10   2 YEAR - BLOOD NOT DONE 
9.11   2 YEAR - BLOOD INCOMPLETE 
9.12   2 YEAR - BLOOD NOT DONE WITHIN FOLLOW-UP WINDOW 
9.13   2 YEAR - MEDICATIONS NOT ASSESSED 
9.14   2 YEAR - MEDICATIONS NOT ASSESSED WITHIN FOLLOW-UP WINDOW 
9.15   2 YEAR - OTHER DEVIATION 
 
3 YEAR 
10.01   3 YEAR - SUBJECT NOT CONTACTED 
10.02   3 YEAR - ASSESSMENT NOT DONE WITHIN FOLLOW-UP WINDOW 
10.03   3 YEAR - PHYSICAL ASSESSMENT / VITAL SIGNS NOT DONE 
10.04   3 YEAR - NYHA NOT DONE 
10.05   3 YEAR - ELECTROCARDIOGRAM NOT DONE 
10.06   3 YEAR - ELECTROCARDIOGRAM NOT DONE WITHIN FOLLOW-UP 
WINDOW 
10.07   3 YEAR - ECHOCARDIOGRAM NOT DONE 
10.08  3 YEAR - ECHOCARDIOGRAM NOT DONE WITHIN FOLLOW-UP WINDOW 
10.09  3 YEAR - BLOOD NOT DONE 
10.10  3 YEAR - BLOOD INCOMPLETE 
10.11  3 YEAR - COAGULATION PROFILE NOT DONE (ONLY REQUIRED FOR 
PATIENTS ON ANTICOAGULANT THERAPY) 
10.12  3 YEAR - BLOOD NOT DONE WITHIN FOLLOW-UP WINDOW 
10.13  3 YEAR - MEDICATIONS NOT ASSESSED 
10.14  3 YEAR - MEDICATIONS NOT ASSESSED WITHIN FOLLOW-UP WINDOW 
10.15  3 YEAR - OTHER DEVIATION 
 
4 YEAR 
11.01   4 YEAR - SUBJECT NOT CONTACTED 
11.02   4 YEAR - ASSESSMENT NOT DONE WITHIN FOLLOW-UP WINDOW 
11.03   4 YEAR - PHYSICAL ASSESSMENT / VITAL SIGNS NOT DONE 
11.04   4 YEAR - NYHA NOT DONE 
11.05   4 YEAR - ELECTROCARDIOGRAM NOT DONE 
11.06   4 YEAR - ELECTROCARDIOGRAM NOT DONE WITHIN FOLLOW-UP 
WINDOW 
11.07 4 YEAR – AUSCULTATION NOT DONE 
11.08  4 YEAR - ECHOCARDIOGRAM NOT DONE (AUSCULTATION INDICATED 
AORTIC MURMUR) 
11.09  4 YEAR - ECHOCARDIOGRAM NOT DONE WITHIN FOLLOW-UP WINDOW 
(AUSCULTATION INDICATED AORTIC MURMUR) 
11.10   4 YEAR - BLOOD NOT DONE 
11.11   4 YEAR - BLOOD INCOMPLETE 
11.12   4 YEAR - BLOOD NOT DONE WITHIN FOLLOW-UP WINDOW 
11.13   4 YEAR - MEDICATIONS NOT ASSESSED 
11.14   4 YEAR - MEDICATIONS NOT ASSESSED WITHIN FOLLOW-UP WINDOW 
11.15   4 YEAR - OTHER DEVIATION 
 
 
 

Edwards Pericardial Aortic Bioprosthesis, Model 11000    
Clinical Trial Number: 2010-03 
 
 
CONFIDENTIAL AND PROPRIETATARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences LLC 
 
Revision C: 8 MAY 2012 
 
 
        
 
 
5 YEAR 
12.01   5 YEAR - SUBJECT NOT CONTACTED 
12.02   5 YEAR - ASSESSMENT NOT DONE WITHIN FOLLOW-UP WINDOW 
12.03   5 YEAR - PHYSICAL ASSESSMENT / VITAL SIGNS NOT DONE 
12.04   5 YEAR - NYHA NOT DONE 
12.05   5 YEAR - ELECTROCARDIOGRAM NOT DONE 
12.06   5 YEAR - ELECTROCARDIOGRAM NOT DONE WITHIN FOLLOW-UP WINDOW 
12.07   5 YEAR - ECHOCARDIOGRAM NOT DONE 
12.08   5 YEAR - ECHOCARDIOGRAM NOT DONE WITHIN FOLLOW-UP WINDOW 
12.09   5 YEAR - BLOOD NOT DONE 
12.10   5 YEAR - BLOOD INCOMPLETE 
12.11   5 YEAR - COAGULATION PROFILE NOT DONE (ONLY REQUIRED FOR PATIENTS ON ANTICOAGULANT THERAPY) 
12.12   5 YEAR - BLOOD NOT DONE WITHIN FOLLOW-UP WINDOW 
12.13   5 YEAR - MEDICATIONS NOT ASSESSED 
12.14   5 YEAR - MEDICATIONS NOT ASSESSED WITHIN FOLLOW-UP WINDOW 
12.15   5 YEAR - OTHER DEVIATION
 
 

Edwards Pericardial Aortic Bioprosthesis, Model 11000 
Clinical Trial Number: 2010‐03 
 
Revision C: 8 MAY 2012 
Confidential
Page 39of 42
 
15.5 DEVICE DEFICIENCY CODES 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Edwards Pericardial Aortic Bioprosthesis, Model 11000    
Clinical Trial Number: 2010-03 
 
 
CONFIDENTIAL AND PROPRIETATARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed 
without written permission from Edwards Lifesciences LLC 
 
Revision C: 8 MAY 2012 
 
 
DEVICE DEFICIENCY CODES 
 
Code    Label 
DD.2    Valve / Holder 
DD.2.01  Device function, packaging not intact 
DD.2.02  Device function, component contamination 
DD.2.03  Device function, unable to remove from jar 
DD.2.04  Device function, unable to place sutures through sewing ring 
DD.2.05  Device function, unable to position on the aortic annulus 
DD.2.06  Device function, bioprosthesis and holder separate during procedure 
DD.2.07  Device function, other, specify 
DD.2.08  Device use, sizing technique 
DD.2.09  Device use, sterility compromised  
DD.2.10  Device use, used expired product 
DD.2.11  Device use, component damaged by operator 
DD.2.12  Device use, improper positioning 
DD.2.13  Device use, other specify 
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Edwards Pericardial Aortic Bioprosthesis, Model 11000 
Clinical Trial Number: 2010‐03 
 
Revision C: 8 MAY 2012 
Confidential
Page 40of 42
 
15.6 ECHO MANUAL 
 
 
 
 

Echo Manual  
 
Clinical Study Number: 2010-03 
 
Revision B: October 29, 2010 
1 
Confidential 
Table of Contents 
1  Purpose
 
 
................................................................................................................................................. 2
2  Introduction
 
 
.......................................................................................................................................... 2
3  Transthoracic echocardiogram (TTE)
 
 
.................................................................................................... 2
3.1   Performing the exam
 
 
.................................................................................................................... 2
3.2   Exam view sequence
 
 
..................................................................................................................... 2
3.3   Data collection
 
 
.............................................................................................................................. 2
4  Transesophageal echocardiogram (TEE)
 
 
............................................................................................... 4
4.1   Performing the exam
 
 
.................................................................................................................... 4
4.2   Exam view
 
 
..................................................................................................................................... 4
4.3   Data collection
 
 
.............................................................................................................................. 4
5  Abbreviated Transthoracic Echocardiogram (aTTE)
 
 ............................................................................. 4
5.1   Performing the exam
 
 
.................................................................................................................... 4
5.2   Exam view sequence
 
 
..................................................................................................................... 5
5.3   Data collection
 
 
.............................................................................................................................. 5
 

Echo Manual  
 
Clinical Study Number: 2010-03 
 
Revision B: October 29, 2010 
2 
Confidential 
1  Purpose 
The purpose of this Echo Manual is to provide instruction on study echocardiograms for clinical 
sites participating in the #2010-03 clinical study. 
2  Introduction 
There are three types of echocardiographic exams required in the #2010-03 clinical study 
protocol: 
 Transthoracic echocardiogram (TTE) 
 Transesophageal echocardiogram (TEE) 
 Abbreviated transthoracic echocardiogram (aTTE) 
Investigation 
Procedure 
Baseline  Implant  Discharge 
3 
month 
1, 3, 5 
year 
2 & 4 
years 
TTE 
X            
X      X      X       
TEE 
      X      
      
             
aTTE 
      X      
      
            X 
 
3  Transthoracic echocardiogram (TTE) 
3.1  Performing the exam 
Study subjects are typically examined in the left lateral decubitus or supine position. All views 
are to be acquired twice for 3 beats. 
The sweep speed for all spectral Doppler and M-mode recordings should be 100 mm/sec. 
Nyquist settings for color Doppler assessment of the cardiac valves should be >50 cm/sec.  
3.2  Exam view sequence 
View 
2-D    Pulse wave   Continuous wave     Color 
Parasternal long axis      
X      
 
 
AV 
Parasternal short axis      X      
AV 
 
AV 
Apical 4-chamber 
X      
 
 
 
Apical 5-chamber 
X      LVOT 
AV      
LVOT / AV 
Apical 2-chamber 
X      
 
 
 
Apical 3-chamber 
X      
AV 
AV      
LVOT / AV 
3.3  Data collection 
The clinical site is to provide the following data for each TTE: 

Echo Manual  
 
Clinical Study Number: 2010-03 
 
Revision B: October 29, 2010 
3 
Confidential 
 Study subject identification number 
 Heart rate (bpm) 
 Height (cm) 
 Weight (kg) 
 Cardiac rhythm 
Data from TTE exams is to include the following measurements/calculations by a Core Lab: 
 Aortic bioprosthesis assessment 
o Flow velocities and gradients 
 Mean gradient 
 Peak gradient 
 Effective orifice area 
 Time velocity integral left ventricular outflow tract 
 Time velocity integral aortic valve 
 Maximum velocity aortic valve 
 Maximum velocity left ventricular outflow tract 
o Aortic insufficiency  
 Central leak grade 
 Paravalvular / perivalvular leak grade 
o Aortic stenosis grade 
 Left ventricle measurements 
o Dimension 
 Left ventricle end-systolic  
 Left ventricle end-diastolic 
 Septal wall thickness (end-diastolic) 
 Posterior wall thickness (end-diastolic) 
o Volume 
 Left ventricle end-systolic  
 Left ventricle end-diastolic 
o Ejection fraction 
 Calculated cardiac performance parameters 
o Cardiac Output 
o Stroke Volume 

Echo Manual  
 
Clinical Study Number: 2010-03 
 
Revision B: October 29, 2010 
4 
Confidential 
4  Transesophageal echocardiogram (TEE) 
4.1  Performing the exam 
Study subjects are typically examined within 1 hour after aortic valve replacement with the 
study device (after the aortic cross clamp is removed).  
4.2  Exam view  
The exact position of the TEE probe may vary from patient to patient, but should be aligned at 
the level of the aortic annulus.  
Doppler requirements in this view: 
 Continuous wave through the aortic valve 
 Color of AV 
4.3  Data collection 
The clinical site is to provide the following data for each TEE: 
 Study subject identification number 
 Heart rate (bpm) 
 Height (cm) 
 Weight (kg) 
 Cardiac rhythm 
Data from TEE exams is to include the following measurements/calculations by a Core Lab: 
 Aortic bioprosthesis assessment 
o Aortic insufficiency  
 Central leak grade 
 Paravalvular / perivalvular leak grade 
5  Abbreviated transthoracic echocardiogram (aTTE) 
5.1  Performing the exam 
Study subjects are typically examined in the left lateral decubitus or supine position.  This exam 
may performed while the subject is still in the Operating Room. All views are to be taken with 2 
captures, the length of which will vary under the following clinical conditions: 
 Sinus rhythm with up to 90bpm: 3 beat capture 
 Sinus rhythm with more than 90bpm: 5 beat capture 

Echo Manual  
 
Clinical Study Number: 2010-03 
 
Revision B: October 29, 2010 
5 
Confidential 
 Frequent atrial or ventricular ectopy: 3 second capture 
 Atrial fibrillation or atrial flutter: 5 second capture 
 Paced rhythm: 5 second capture 
The sweep speed for all spectral Doppler and M-mode recordings should be 100 mm/sec. 
Nyquist settings for color Doppler assessment of the aortic valve should be >50 cm/sec.  
5.2  Exam view sequence 
View 
2-D     Pulse wave   Continuous wave     Color 
Parasternal short axis      X      
AV 
 
AV 
Apical 4-chamber 
X      
 
 
 
Apical 3-chamber 
X      
AV 
AV      
LVOT / AV 
 
5.3  Data collection 
The clinical site is to provide the following data for each aTTE: 
 Study subject identification number 
 Heart rate (bpm) 
 Height (cm) 
 Weight (kg) 
 Cardiac rhythm 
Data from aTTE exams is to include the following measurements/calculations by a Core Lab: 
 Aortic bioprosthesis assessment 
o Aortic insufficiency  
 Central leak grade 
 Paravalvular / perivalvular leak grade 
o Aortic stenosis grade  

Edwards Pericardial Aortic Bioprosthesis, Model 11000 
Clinical Trial Number: 2010‐03 
 
Revision C: 8 MAY 2012 
Confidential
Page 41of 42
 
15.7 EQ‐5D QUESTIONNAIRE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Edwards Pericardial Aortic Bioprosthesis, Model 11000 
Clinical Trial Number: 2010‐03 
 
Revision C: 8 MAY 2012 
Confidential
Page 42of 42
 
15.8 SF‐12 V2 QUESTIONNAIRE 
 

 
EDWARDS 
          STUDY NUMBER 2010-03 
CLINICAL STUDY OF THE EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS, 
MODEL 11000  
QUALITY OF LIF E 
P AGE 1 OF 3 
 
 
Subject Study ID #  2  0  1  0  0  3 -           
     
Site#               
 
 
1SF-12v2
™ Health Survey© 1994, 2002 by QualityMetric incorporated and Medical Outcomes Trust. 
SF-12® a registered trademark of Medical Outcomes Trust. (SF12v2 Standard, US version 2.0). 
 
QualityMetric’s SF-12v2® Health Survey1 is a shorter version of the SF-36v2® Health Survey that uses just 12 
questions to measure functional health and well-being from the subject’s point of view.  It takes only 2-3 
minutes to complete.  The SF-12v2 is a practical, reliable, and valid measure of physical and mental health and 
covers the same eight health domains as the SF-36v2 with one or two questions per domain.  
 
 
VISIT INTERVAL: 
   SCREENING      1 YEAR 
 
 
Date of Assessment: 
                ___ ___ / ___  ___  ___  /  ___  ___  ___  ___  
                                                                D     D       M    M     M         Y     Y     Y      Y  
 
1. In general, would you say your health is: 
 
Excellent 

Very good 
1 

Good 
2 

Fair 
3 

Poor 
4 

 
5 
 
2. The following questions are about activities you might do during a typical day.  Does your health now limit 
you
 
 in these activities?  If so, how much? 
 
 
 
Yes, limited a 
lot 
Yes, limited a 
little 
No, not 
limited at all 
a. Moderate  activities
 
,  such  as  moving  a 
table,  pushing  a  vacuum  cleaner,  bowling, 
or playing golf. 
 

 
1 

 
2 

b. Climbing 
3 
several

 flights of stairs. 

1 

2 
 
3 
 
3. During the past 4 weeks, how much of the time have you had any of the following problems with your work or 
other regular daily activities as a result of your physical health
 
? 
      
      
      
All of the 
time 
Most of 
the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
a. Accomplished  less
 
 than  you 
would like. 
 

 
1 

 
2 

 
3 

 
4 

                                                     
 
5 

 
EDWARDS 
          STUDY NUMBER 2010-03 
CLINICAL STUDY OF THE EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS, 
MODEL 11000  
QUALITY OF LIF E 
P AGE 2 OF 3 
 
 
Subject Study ID #  2  0  1  0  0  3 -           
     
Site#               
 
 
1SF-12v2
™ Health Survey© 1994, 2002 by QualityMetric incorporated and Medical Outcomes Trust. 
SF-12® a registered trademark of Medical Outcomes Trust. (SF12v2 Standard, US version 2.0). 
 
 
b. Were  limited  in  the  kind
 
 of 
work or other activities. 
    
1 

2 

3 

4 
4. During the 
5 
past 4 weeks, how much of the time have you had any of the following problems with your work or 
other regular daily activities as a result of any emotional problem
 
s (such as feeling depressed or anxious)? 
      
      
All of the 
time 
Most of 
the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
a. Accomplished  less
 
 than  you 
would like. 
 

 
1 

 
2 

 
3 

 
4 

b. Did  work  or  activities 
5 
less 
carefully than usual

? 

1 

2 

3 

4 
 
5 
 
5. During the past 4 weeks, how much did pain
Not at all 
 interfere with your normal work (including both work 
outside the home and housework)? 

A little bit 
1 

Moderately 
2 

Quite a bit 
3 

Extremely 
4 

 
5 
 
6. These questions are about how you feel and how things have been with you during the past 4 
weeks. For each question, please give one answer that comes closest to the way you have been 
feeling.  How much of the time during the past 4 weeks
 
 ……
 
      
      
All of the 
time 
Most of 
the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
a. Have you felt calm and 
peaceful? 
 
 

 
1 

 
2 

 
3 

 
4 

b. Did you have a lot of energy? 
5 
 
    
1 

2 

3 

4 
c. Have you felt downhearted 
and depressed? 
5 
    
1 

2 

3 

4 
 
5 
7. During the past 4 weeks, how much of the time has your physical health or emotional problems 
interfered with your social activities (like visiting friends, relatives, etc.)? 

 
EDWARDS 
          STUDY NUMBER 2010-03 
CLINICAL STUDY OF THE EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS, 
MODEL 11000  
QUALITY OF LIF E 
P AGE 3 OF 3 
 
 
Subject Study ID #  2  0  1  0  0  3 -           
     
Site#               
 
 
1SF-12v2
™ Health Survey© 1994, 2002 by QualityMetric incorporated and Medical Outcomes Trust. 
SF-12® a registered trademark of Medical Outcomes Trust. (SF12v2 Standard, US version 2.0). 
 
All of the 
time 

Most of the 
time 
1 

Some of the 
time 
2 

A little of the 
time 
3 

None of the 
time 
4 

 
5 
 
 
 
 
I HAVE REVIEWED AND AGREE WITH ALL DATA ENTERED ON THIS FORM 
 
 
DATE SIGNED 
                             
INVESTIGATOR SIGNATURE 
 
D  D    M  M  M    Y  Y  Y  Y