CardioMEMS HF System Post Approval Study
Conditions: Heart Failure, Left-Sided Heart Failure, Congestive Heart Failure
Sponsor: Abbott Medical Devices

SJM-CIP-10035 Ver. C 
CardioMEMSTM HF System Post Approval Study 
Clinical Investigation Plan 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used 
without the express written consent of Abbott 
Template: 86357 Rev. D 
Page 1 of 68 
 
SJM-CIP-10035 
CardioMEMSTM HF System Post Approval Study 
Version Number 
C 
Date 
February 19, 2018 
Steering Committee 
Lynne Warner-Stevenson, MD (Chair) 
William Abraham, MD 
Robert Bourge, MD 
Maria Rosa Costanzo, MD 
Akshay Desai, MD 
James Heywood, MD 
Lisa Rathman, CRNP 
Nirav Raval, MD 
David Shavelle, MD 
Richard Shlofmitz, MD  
Planned Number of Sites and 
Region(s) 
Up to 150 clinical sites in the United States 
Clinical Investigation Type 
Prospective, multi-center, open-label clinical trial 
Abbott Medical Expert 
Philip B. Adamson, MD, MSc, FACC  
Divisional Vice President and Medical Director  
6300 Bee Cave Rd, Bldg 2. #100 
Austin, TX  78746 USA 
Tel: +1 512 286 4526 
Email: philip.adamson@abbott.com 
 
Sponsor 
 
St. Jude Medical 
23 Fourth Avenue 
Burlington, MA 01803 
United States of America 
Electronic Data Capture Software 
Oracle Clinical 
CIP Author of Current Version  
Jason Berlin 
 
 

SJM-CIP-10035 Ver. C 
CardioMEMSTM HF System Post Approval Study 
Clinical Investigation Plan 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used 
without the express written consent of Abbott 
Template: 86357 Rev. D 
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Table of Contents 
1. 
LIST OF ABBREVIATIONS .............................................................................................. 6 
2. 
PROTOCOL SYNOPSIS .................................................................................................. 7 
3. 
SUB-STUDY PROTOCOL SYNOPSIS ............................................................................. 9 
4. 
BACKGROUND AND RATIONALE ................................................................................12 
4.1. 
Introduction ........................................................................................................ 12 
4.2. 
CHAMPION Trial Results ................................................................................... 12 
4.3. 
Indication for Use ............................................................................................... 12 
4.4. 
CardioMEMS HF System ................................................................................... 12 
5. 
STUDY OBJECTIVE .......................................................................................................14 
6. 
STUDY DESIGN ..............................................................................................................14 
7. 
STUDY POPULATION ....................................................................................................15 
7.1. 
Inclusion Criteria ................................................................................................ 15 
7.2. 
Exclusion Criteria ............................................................................................... 15 
7.3. 
Study or Site Termination ................................................................................... 15 
8. 
STUDY PROCEDURES ..................................................................................................16 
8.1. 
Screening Visit ................................................................................................... 16 
8.2. 
Right Heart Catheterization and Implant Procedure (Baseline Visit) ................... 17 
8.3. 
Study Follow-Up Visits 1, 2, 3, 4, and 5 (Months 1, 6, 12, 18, and 24) ............... 18 
8.4. 
Subject Home PA Pressure Readings ................................................................ 19 
8.5. 
PA Pressure Readings in the Hospital ............................................................... 19 
8.6. 
Criteria for Withdrawal ....................................................................................... 19 
8.7. 
Deviations from CIP ........................................................................................... 20 
9. 
SAFETY ANALYSES ......................................................................................................20 
9.1. 
Primary Safety Endpoints ................................................................................... 20 
9.1.1. 
Device / System-related Complication Criteria .....................................21 
9.1.2. 
Sensor Failure Criteria .........................................................................21 
10. 
EFFECTIVENESS ANALYSES .......................................................................................21 
10.1. 
Primary Effectiveness Endpoint ......................................................................... 21 
10.2. 
Supplemental Analyses...................................................................................... 21 
10.2.1. Mortality ...............................................................................................21 
10.2.2. HF Hospitalization or Death .................................................................21 
10.2.3. Patient Compliance ..............................................................................21 

SJM-CIP-10035 Ver. C 
CardioMEMSTM HF System Post Approval Study 
Clinical Investigation Plan 
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10.2.4. Training Evaluation ..............................................................................21 
10.2.5. Subgroup Analyses ..............................................................................21 
10.2.6. Quality of Life Evaluations ....................................................................21 
11. 
ADVERSE EVENTS ........................................................................................................21 
11.1. 
Adverse Event (AE) ........................................................................................... 22 
11.2. 
Serious Adverse Event (SAE) ............................................................................ 22 
11.3. 
Device-Relatedness ........................................................................................... 22 
11.4. 
Procedures for Reporting Adverse Events (AEs)................................................ 22 
11.5. 
Criteria and Guidelines for Non-reportable Events ............................................. 23 
11.6. 
Anticipated Adverse Events ............................................................................... 23 
11.6.1. Anticipated AEs ....................................................................................23 
11.6.2. Anticipated ADEs/SADEs .....................................................................24 
12. 
STATISTICAL ANALYSIS ..............................................................................................25 
12.1. 
Populations for Analysis ..................................................................................... 25 
12.2. 
Sample Size Considerations .............................................................................. 25 
12.3. 
Missing Data ...................................................................................................... 26 
12.4. 
Subject Accountability and Baseline Information ................................................ 26 
12.5. 
Demographic and Baseline Information ............................................................. 26 
12.6. 
Safety Analyses ................................................................................................. 26 
12.6.1. Primary Safety Endpoints .....................................................................26 
12.7. 
Effectiveness Analyses ...................................................................................... 27 
12.7.1. Primary Effectiveness Endpoint ............................................................27 
12.7.2. Supplemental Analyses ........................................................................27 
13. 
PAS SUB-STUDY ...........................................................................................................28 
13.1. 
Sub-study Design............................................................................................... 28 
13.2. 
Sub-study Hypotheses ....................................................................................... 28 
13.3. 
Sub-study Population (device and control group) ............................................... 29 
13.4. 
Sub-study Sample Size ...................................................................................... 29 
13.5. 
Sub-study Endpoints .......................................................................................... 29 
13.5.1. Sub-study Safety Endpoints .................................................................29 
13.5.2. Device / System-related Complication Criteria .....................................29 
13.5.3. Sensor Failure Criteria .........................................................................30 
13.5.4. Sub-study Effectiveness Endpoint ........................................................30 

SJM-CIP-10035 Ver. C 
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Clinical Investigation Plan 
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13.5.5. Sub-study Supplemental Analyses .......................................................30 
13.6. 
Sub-study Enrollment Plan ................................................................................. 30 
13.7. 
Sub-study Length of Follow-up........................................................................... 30 
13.8. 
Sub-study Frequency of Follow-up Assessments ............................................... 30 
13.9. 
Sub-study Statistical Plan .................................................................................. 31 
13.9.1. Analysis of Sub-study Safety Endpoints ...............................................31 
13.9.2. Analysis of Sub-study Effectiveness Endpoints ....................................31 
13.9.3. Schematic Diagram of the Sub-study and Main PAS Study ..................31 
14. 
REPORTING OF INTERIM AND PRIMARY ANALYSES ................................................31 
15. 
CLINICAL EVENTS COMMITTEE ...................................................................................31 
16. 
DATA COLLECTION, STUDY MONITORING, AND DATA DISCLOSURE ....................32 
16.1. 
Data Collection and Reporting ........................................................................... 32 
16.2. 
Site Qualification ................................................................................................ 32 
16.3. 
Training .............................................................................................................. 32 
16.4. 
Study Monitoring ................................................................................................ 33 
16.5. 
Source Data Verification .................................................................................... 33 
16.6. 
Definition of Source Data ................................................................................... 33 
16.7. 
Data Disclosure and Subject Confidentiality ....................................................... 33 
17. 
ETHICAL CONSIDERATIONS AND STUDY ADMINISTRATION ...................................34 
17.1. 
Human Subjects Protection ................................................................................ 34 
17.2. 
Protocol Amendments ........................................................................................ 34 
17.3. 
Retention of Records ......................................................................................... 34 
17.4. 
Finance, Insurance, and Publication .................................................................. 35 
18. 
REFERENCES ................................................................................................................36 
19. 
APPENDICES .................................................................................................................37 
APPENDIX A: ANTICIPATED STUDY TIMELINE ....................................................................37 
APPENDIX B: SCHEDULE OF EVENTS .................................................................................38 
APPENDIX C:  NYHA FUNCTIONAL CLASSIFICATION FOR HEART FAILURE...................39 
APPENDIX D:  MANAGEMENT OF HEMODYNAMIC PARAMETERS ....................................40 
APPENDIX E:  KANSAS CITY CARDIOMYOPATHY QUESTIONNAIRE-12 ...........................44 
APPENDIX F:  BRIEF ILLNESS PERCEPTION QUESTIONNAIRE (ENGLISH) .....................46 
APPENDIX G: CARDIAC HEALTH SECURITY SURVEY ........................................................47 
APPENDIX H:  BMI CALCULATOR .........................................................................................49 

SJM-CIP-10035 Ver. C 
CardioMEMSTM HF System Post Approval Study 
Clinical Investigation Plan 
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without the express written consent of Abbott 
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APPENDIX I:  GLOMERULAR FILTRATION RATE .................................................................50 
APPENDIX J:  PROTOCOL DEFINITIONS ..............................................................................51 
APPENDIX K:  COMPOSITION, FUNCTION, AND PROCEDURES OF THE CLINICAL EVENTS 
COMMITTEE (CEC) ........................................................................................................52 
APPENDIX L:  REPORTING OF INTERIM ANALYSES ...........................................................53 
APPENDIX M:  SCHEMATIC DIAGRAM OF MAIN PAS STUDY AND SUBSTUDY ................57 
APPENDIX N:  INFORMED CONSENT TEMPLATE ................................................................58 
 
 

SJM-CIP-10035 Ver. C 
CardioMEMSTM HF System Post Approval Study 
Clinical Investigation Plan 
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express written consent of Abbott 
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LIST OF ABBREVIATIONS 
AE 
Adverse Event 
ADE 
Adverse Device Effect 
CEC 
Clinical Events Committee 
CRF 
Case Report Form 
CRT-D 
Cardiac Resynchronization Therapy Defibrillator 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GFR 
Glomerular Filtration Rate 
HF 
Heart Failure 
ICH 
International Committee on Harmonization 
ICD 
Implantable Cardioverter Defibrillator 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
IV 
Intravenous 
KCCQ 
Kansas City Cardiomyopathy Questionnaire 
LVEF 
Left Ventricular Ejection Fraction 
MedDRA 
Medical Dictionary for Regulatory Activities  
MDR 
Medical Device Reporting 
MEMS 
Micro-electromechanical Systems 
NYHA 
New York Heart Association 
OPC 
Objective Performance Criterion 
PA 
Pulmonary Artery 
PAS 
Post Approval Study 
PI 
Principal Investigator 
PMA 
Post-Market Approval 
PT 
Prothrombin Time 
PTT 
Partial Thromboplastin Time 
RHC 
Right Heart Catheterization 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SOP 
Standard Operating Procedure 
VAD 
Ventricular Assist Device 
 
 

SJM-CIP-10035 Ver. C 
CardioMEMSTM HF System Post Approval Study 
Clinical Investigation Plan 
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PROTOCOL SYNOPSIS 
Sponsor: 
St. Jude Medical, Burlington, MA 
Protocol Title: 
CardioMEMSTM HF System Post Approval Study 
Document Control 
Number: 
SJM-CIP-10035 
Device: 
The CardioMEMS HF System consists of a wireless, battery-less 
pressure sensor implanted into the pulmonary artery and an external 
electronics that powers and communicates with the sensor and 
transmits pulmonary artery pressure waveforms and measurements 
to a secure website for Investigator review and patient management. 
Purpose: 
The purpose of this Post Approval Study (PAS) is to evaluate the use 
of the CardioMEMS HF System in patients with Class III Heart 
Failure (HF) in a commercial setting.   
Objective: 
The objective of this PAS is to confirm safety and effectiveness in a 
commercial setting.   
Study Population: 
Adults with New York Heart Association (NYHA) Class III Heart 
Failure who have experienced a heart failure hospitalization within 
the past 12 months.  At least 35% of the enrolled patients will be 
women. 
The patients will serve as their own historical controls for 
effectiveness (1 year prior implantation). 
All subjects who sign the informed consent form and satisfy the 
inclusion/exclusion criteria. 
Ejection fraction data must be taken within the last 3 months to enroll in 
the study. 
Study Design: 
This is a prospective, multi-center, open-label trial conducted in the 
United States (US).   
All subjects who sign the informed consent form and satisfy the 
inclusion/exclusion criteria will be enrolled into the CardioMEMS HF 
System PAS and will be scheduled for follow-up visits at 1 month 
and every 6 months for 2 years. 
Following sensor implant and hospital discharge, subjects will take 
PA pressure measurements on a daily basis, or as directed by the 
investigator.  These measurements will be automatically transmitted 
to the secure Patient database (CardioMEMS HF website).   
Timeline: 
Study visits will be scheduled at Month 1, Month 6, and every 6 
months thereafter for 2 years or until study termination. 

SJM-CIP-10035 Ver. C 
CardioMEMSTM HF System Post Approval Study 
Clinical Investigation Plan 
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Number of Subjects 
Twelve hundred subjects will be enrolled with at least 35% of the 
enrolled patients being women (420 women out of 1200).  Enrollment 
will be limited to 15% of the total study population at any one site.  
Number of Sites: 
This is a prospective, multi-center, open-label clinical trial to be 
conducted at up to 150 sites. 
Safety Measures: 
Primary safety endpoints will be evaluated at 2 years: 1) freedom 
from device/system related complications and 2) freedom from 
pressure sensor failure.  
Safety will also be assessed throughout the study by the frequency 
of Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) 
and Serious Adverse Device Effects (SADEs).  A Clinical Events 
Committee (CEC) will evaluate all SAEs to determine whether or not 
the SAE is device / system-related complication or pressure sensor 
failure.  
Effectiveness 
Measures: 
The primary effectiveness endpoint is the annualized HF 
hospitalization rate at 1 year 
.   
Supplemental analyses include mortality at 1 year, HF hospitalization 
or death at 1 year, patient compliance over the trial, training 
evaluation, Quality of Life evaluations, and subgroup analyses.   
Information regarding all hospitalizations and deaths will be collected 
throughout the study and will be adjudicated by the CEC.   
PAS Sub-study: 
Sub-study within the main PAS cohort with an effectiveness endpoint 
of comparison of the HF hospitalization rate over 1 year in study to 
the 1 year HF hospitalization rate in Part 1 of the CHAMPION trial 
Control Cohort. The safety endpoints will be the same as the main 
PAS cohort. 
Statistical 
Considerations: 
Primary Safety Endpoints 
The primary safety hypotheses are that the device / system-related 
complication-free proportion of subjects will be at least 80% at 24 
months (OPC used in the CHAMPION trial) and that the pressure 
sensor failure-free proportion of subjects will be at least 90% at 24 
months (OPC used in the CHAMPION trial).  Plotting and analysis of 
safety endpoints will also be displayed using Kaplan-Meier methods. 
All safety analyses will be performed on the safety population. 
Primary Effectiveness Endpoint  
The primary effectiveness evaluation will compare the annualized HF 
hospitalization rate at 1 year compared to the HF hospitalization rate 
in the year prior to enrollment.   

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Clinical Investigation Plan 
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The effectiveness population consists of all subjects who received a 
sensor implant regardless of study completion status.   
Supplemental Analyses  
Mortality at 1 year will be analyzed.  Plotting and analysis of mortality 
will be displayed using Kaplan-Meier methods. 
The annualized HF hospitalization or death rate at 1 year in study will 
be compared to the HF hospitalization rate in the year prior to 
enrollment. 
Patient compliance over the trial will be examined.  The total number 
of pulmonary artery (PA) pressure readings taken will be reported as 
a percentage of patient days at home. 
To assess the effectiveness of the training program, the safety and 
effectiveness results will be reported for Academic Hospitals and 
Community Hospitals. 
Effectiveness analyses will be performed by the following subgroups:  
Women, Men, Reduced Ejection Fraction (< 40%), Preserved 
Ejection Fraction (≥ 40%), Ischemic Etiology, Non-ischemic Etiology, 
With ICD/CRT-D, and Without ICD/CRT-D. 
Reporting of Interim and 
Primary Analyses 
In addition to the primary safety and effectiveness analyses, updates 
from the PAS will be submitted to FDA as a PMA supplement every 
6 months for the first two years of the study (annually thereafter) and 
updated in the device labeling.  This information will include the 
following: study enrollment and follow-up status; demographic 
information; safety and effectiveness results; mortality; serious 
adverse events; days alive outside of the hospital for heart failure; 
patient compliance; sensor performance; and medication changes in 
response to PA pressure. 
The primary safety analyses will be reported after all patients 
complete 24 months post enrollment or discontinue early.  The 
primary effectiveness analyses will be reported after all patients 
complete 12 months post enrollment or discontinue early. 
Version: 
C 
Date: 
19 February 2018 
SUB-STUDY PROTOCOL SYNOPSIS 
Sub-Study Purpose: 
The purpose of this sub-study is to evaluate the use of the 
CardioMEMS™ HF System in a commercial setting in patients with 
NYHA Class III heart failure who are optimally managed and are 
clinically similar to the Control group in the CHAMPION study based 
on pre-enrollment data.   

SJM-CIP-10035 Ver. C 
CardioMEMSTM HF System Post Approval Study 
Clinical Investigation Plan 
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Sub-Study Objective: 
The objective of this sub-study is to confirm the post-market safety 
and effectiveness of the CardioMEMS™ HF System to premarket.   
Sub-Study Population: 
The sub-study patient population will consist of patients selected by 
an independent committee from the PAS (Main Cohort) who are 
optimally managed and are clinically similar to the Control group in 
the CHAMPION study based on pre-enrollment data.  The 
independent committee will identify these patients from the main 
cohort with NYHA Class III HF who have experienced a HF 
hospitalization within the past 12 months. 
Sub-Study Design: 
This is a prospective, multi-center, open-label trial conducted in the 
United States (US).   
All subjects who sign the informed consent form, satisfy the 
inclusion/exclusion criteria, and are selected by the independent 
committee from the PAS (Main Cohort) will be included in the sub-
study.  Patients will be scheduled for follow-up visits at 1 month and 
every 6 months for 2 years. 
Following sensor implant and hospital discharge, subjects will take 
PA pressure measurements on a daily basis, or as directed by the 
investigator.  These measurements will be automatically transmitted 
to the secure Patient database (CardioMEMS HF website).   
Timeline: 
Study visits will be scheduled at Month 1, Month 6, and every 6 months 
thereafter for 2 years or until study termination. 
Sub-Study Number of 
Subjects 
A minimum of 256 patients will be selected by the independent committee 
for inclusion in the sub-study.  However, the independent committee will 
identify all patients that are optimally managed and are clinically similar to 
the Control group in the CHAMPION study (Part 1).  Therefore, the eligible 
patients for this sub-study cohort and the resultant sample size may be 
greater.  
Number of Sites: 
This is a prospective, multi-center, open-label clinical trial to be conducted 
at up to 150 sites. 
Sub-Study Safety 
Measures: 
Primary safety endpoints will be evaluated at 2 years: 1) freedom 
from device/system related complications and 2) freedom from 
pressure sensor failure.  
Safety will also be assessed throughout the study by the frequency 
of Adverse Device Effects (ADEs), Serious Adverse Events (SAEs), 
and Serious Adverse Device Effects (SADEs).  A Clinical Events 
Committee (CEC) will evaluate all SAEs to determine whether or not 
the SAE is a device / system-related complication or pressure sensor 
failure.  
Sub-Study 
The primary effectiveness objective is to demonstrate that there is 

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Clinical Investigation Plan 
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Effectiveness 
Measures: 
not a worsening in HF hospitalization rate at 1 year in the sub-study 
compared to the 1 year HF hospitalization rate in the CHAMPION 
study Control group (Part 1).    
Sub-Study Statistical 
Considerations: 
Primary Safety Endpoints 
The primary safety hypotheses are that the device / system-related 
complication-free proportion of subjects will be at least 80% at 24 
months (OPC used in the CHAMPION trial) and that the pressure 
sensor failure-free proportion of subjects will be at least 90% at 24 
months (OPC used in the CHAMPION trial).  Plotting and analysis of 
safety endpoints will also be displayed using Kaplan-Meier methods. 
All safety analyses will be performed on the safety population. 
Primary Effectiveness Endpoint  
The primary effectiveness evaluation will compare the HF 
hospitalization rate over 1 year in the sub-study to the 1 year HF 
hospitalization rate in the Control group (Part 1) of the CHAMPION 
trial.  
The effectiveness population consists of all subjects who received a 
sensor implant regardless of study completion status.   
Supplemental Analyses  
To assess the effectiveness of the training program, the safety and 
effectiveness results will be reported for Academic Hospitals and 
Community Hospitals. 
Effectiveness analyses will be performed by the following subgroups:  
Women, Men, Reduced Ejection Fraction (< 40%), Preserved 
Ejection Fraction (≥ 40%), Ischemic Etiology, Non-ischemic Etiology, 
With ICD/CRT-D, and Without ICD/CRT-D. 
Reporting of Interim and 
Primary Analyses 
In addition to the primary safety and effectiveness analyses, updates 
from the PAS will be submitted to FDA as a PMA supplement every 
6 months for the first two years of the study (annually thereafter) and 
updated in the device labeling.  This information will include the 
following: study enrollment and follow-up status; demographic 
information; safety and effectiveness results; mortality; serious 
adverse events; days alive outside of the hospital for heart failure; 
patient compliance; sensor performance; and medication changes in 
response to PA pressure. 
The primary safety analyses will be reported after all patients 
complete 24 months post enrollment or discontinue early.  The 
primary effectiveness analyses will be reported after all patients 
complete 12 months post enrollment or discontinue early. 
 
 
 

SJM-CIP-10035 Ver. C 
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BACKGROUND AND RATIONALE 
4.1. 
Introduction 
Heart failure (HF) is a clinical syndrome characterized by frequent hospitalization, poor quality of life, 
multiple comorbidities, high mortality and a complex therapeutic regimen.  Affected individuals have a 
variety of symptoms such as dyspnea, fatigue, limited exercise tolerance, fluid retention, pulmonary 
congestion and peripheral edema.  Patients suffer impairment in functional capacity and quality of life.   
The incidence of HF is on the rise, affecting more than 5 million people in the US alone. Despite current 
guideline recommended therapies, rates of heart failure hospitalization remain high. Heart failure is the 
primary diagnosis in >1 million hospitalizations annually. Patients hospitalized for HF are at high risk for 
all-cause rehospitalization, with a 1-month readmission rate of 25% (Go, et al., 2013). 
4.2. 
CHAMPION Trial Results 
The CHAMPION trial demonstrated that management of heart failure using pulmonary artery pressure 
information obtained with the CardioMEMS HF System, in addition to traditional signs and symptoms, 
reduced HF hospitalizations.   
The CHAMPION trial was conducted at 64 U.S. centers and enrolled 550 patients with NYHA Class III 
heart failure who had been hospitalized for heart failure in the previous year.  All patients were implanted 
with a sensor and then randomized to Treatment (heart failure management on the basis of pulmonary 
artery pressure and standard of care) or Control (heart failure management on the basis of standard of 
care). CHAMPION met its primary endpoint of reduction in the rate of heart failure hospitalizations at 6 
months with Treatment patients having 28% fewer heart failure hospitalizations compared to Control 
patients; benefit was sustained with a 37% reduction in heart failure hospitalizations over the full 
randomized study duration (Abraham, et al., 2011).  All secondary endpoints were met with reduction in 
pulmonary artery pressures, reduction in proportion of patients hospitalized for heart failure, increase in 
days alive outside the hospital and improved quality of life.  
4.3. 
Indication for Use 
The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) 
pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have 
been hospitalized for heart failure in the previous year.  The hemodynamic data are used by physicians 
for heart failure management and with the goal of reducing heart failure hospitalizations. 
4.4. 
CardioMEMS HF System  
The CardioMEMS™ HF System provides PA hemodynamic data used for the monitoring and 
management of HF patients. The system measures changes in PA pressure which physicians use to 
initiate or modify heart failure treatment. 
The system includes the following components: 
• 
Implantable wireless sensor with delivery catheter 
• 
Patient or hospital electronics system 
• 
Patient database (CardioMEMS HF Website) 
 
 
 

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Figure 1.  CardioMEMS HF System 
 
 
 
 
  
 
The system provides the physician with the patient’s PA pressure waveform including systolic, diastolic, 
and mean pressures as well as heart rate.  The Sensor is permanently implanted into the distal PA using 
transcatheter techniques in the catheterization laboratory; the sensor baseline is set to the mean PA 
pressure using a pulmonary artery catheter.  Daily PA hemodynamic measurements are taken by the 
patient in a supine position at home.  The patient measurement system consists of an antenna and 
electronics unit that guides the patient through the short reading process.  The data can be recorded 
from the home, hospital, physician’s office, or clinic.  The hemodynamic data is transmitted to the website 
which is accessible via a secure website to the patient’s physician or nurse. 
Implantable Sensor  
The sensor measures pulmonary artery pressure using MEMS (micro-electromechanical systems) 
technology and requires neither batteries nor leads. It is silicon wafer fabricated and measures 15 mm in 
length, 3.4 mm in width and 2 mm in thickness.  The sensor is permanently implanted in a branch of the 
left or right pulmonary artery via a catheter. The Patient Electronics Unit provides both wireless 
communication and power to the sensor. 
Implantable Sensor Delivery System 
PA Pressure Sensor on Catheter Delivery System
120cm
4.5cm
Patient Home 
Electronics Unit
PA Pressure Database
Physician Access Via Secure Website

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The sensor is tethered to an over-the-wire delivery catheter. A right heart catheterization is performed, 
and a hand injected selective pulmonary angiogram is performed via the pulmonary artery catheter to 
define the distal pulmonary artery branch anatomy.  An 0.018” guidewire is then advanced through the 
pulmonary artery catheter into the distal pulmonary artery.  The pulmonary artery catheter is removed, 
and the delivery system is advanced over the guidewire.  Once it is optimally positioned, the sensor is 
separated from the delivery system by releasing the tether wires and delivery system is then removed.   
Patient Electronics System 
The electronics unit uses an antenna to transmit low power pulses of radiofrequency energy to power 
and communicate with the sensor. The electronics unit transmits the PA pressure information to the 
CardioMEMS HF Website. 
CardioMEMS HF Website 
The CardioMEMS HF Website provides a secure user interface through a website for the clinician to 
review the PA pressure data from the CardioMEMS HF System.  
STUDY OBJECTIVE 
The objective of this Post Approval Study is to provide safety and effectiveness data regarding the use of 
the CardioMEMS HF System in a commercial setting. 
STUDY DESIGN 
This is a prospective, multi-center, open-label clinical trial to be conducted up to 150 sites in the US.        
Subjects who sign the informed consent form and meet the eligibility criteria at the Baseline visit will be 
eligible for the trial.  Subjects will undergo the study-related procedures, including clinical laboratory 
measurements and body mass index (BMI) calculation.  Note that for study related procedures/visits 
Investigator refers to the Principal Investigator or designee. 
Eligible subjects will be scheduled for the Implant procedure (PA sensor implant in conjunction with a 
RHC procedure).   
Subjects must also have an appropriately sized (≥7mm diameter) pulmonary artery branch identified by a 
selective pulmonary angiogram prior to Sensor implant.  Subjects who do not meet this inclusion criteria 
will be documented as consented not implanted and will be followed for 30 days for safety.   
Prior to hospital discharge, subjects will be trained on the home monitoring system and instructed to take 
pulmonary artery pressure measurements daily or as directed by their physician.    Subjects will be 
supplied with a patient implant identification card, a Patient System Manual, and a Helpline phone 
number. 
After discharge, the subject will take PA pressure measurements at home, as directed by the 
investigator, utilizing the CardioMEMS HF System.  These measurements will be transmitted via modem 
to a secure data base. Patient compliance will be monitored by the sponsor and reported to the 
Investigator.   
The Investigator or designee will review the PA pressure measurements transmitted from the home 
monitoring unit.  Pressure thresholds are automatically set as described in Appendix D.  These threshold 
notifications are intended to guide the Investigator to review the CardioMEMS HF Website.  If the PA 
pressures are elevated or low, the Investigator or designee should make medication changes according 
to the guidelines in Appendix D.  The Investigator or designee will review the PA pressure measurements 
on a weekly basis at a minimum and appropriately utilize the information obtained to assist in the clinical 
management of subjects.  Weekly logins to the database will be monitored by the sponsor.  Reminders 

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will be sent to the clinical sites if there are no logins noted during the course of a 7 day window.    Clinical 
and technical support will be available to the Investigator as needed.   
Follow-up study visits will be scheduled at Month 1, Month 6, and every 6 months thereafter for 2 years.  
Follow-up visits will include a physical exam, evaluation of NYHA Class (Appendix C), AE assessment, 
HF medications review, and assessment of any hospitalizations that may have occurred between visits.  
STUDY POPULATION 
Study subjects must meet the following inclusion and none of the exclusion criteria to be eligible for the 
study: 
7.1. 
Inclusion Criteria 
1. Written informed consent obtained from subject or legal representative  
2. > 18 years of age 
3. Diagnosis of NYHA Class III Heart Failure  Note: Subjects who are on continuous inotrope 
therapy should be considered in Stage D refractory heart failure and are not eligible for 
enrollment in the study.       
4. At least 1 HF hospitalization within 12 months of Baseline visit 
5. Subjects with reduced LVEF heart failure should be receiving a beta blocker for 3 months and 
an ACE-I or ARB for one month unless in the investigator’s opinion, the subject is intolerant to 
beta blockers, ACE-I or ARB.   
6. Subjects with a BMI ≤ 35.  Subjects with BMI >35 will require their chest circumference to be 
measured at the axillary level, if > 65 inches the patient will not be eligible for the study.    
7. Subjects with pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed 
during the RHC) 
8. Subjects willing and able to comply with the follow-up requirements of the study 
7.2. 
Exclusion Criteria 
1. Subjects with an active infection 
2. Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis 
3. Subjects who, in the Investigator’s opinion, are unable to tolerate a right heart catheterization 
4. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart 
surgery, stroke, etc.) within 2 months of Baseline Visit 
5. Subjects with Cardiac Resynchronization Device (CRT) implanted < 3 months prior to 
enrollment 
6. Subjects with a Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of the 
baseline visit) who are non-responsive to diuretic therapy or who are on chronic renal dialysis 
7. Subjects with congenital heart disease or mechanical right heart valve(s) 
8. Subjects who have received a Ventricular assist device (VAD) or are likely to undergo heart 
transplantation or VAD within 6 months of baseline visit. 
9. Subjects with known coagulation disorders 
10. Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel 
7.3. 
Study or Site Termination 

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The Sponsor or the Investigator has the right to discontinue the study at any time.  As much as possible, 
this should occur after mutual consultation.  The Investigator (or sponsor, where appropriate) is 
responsible for informing the Institutional Review Board (IRB) of trial closure. 
Conditions may arise during the study that could prompt termination of the study or the study sites.  
Conditions that may prompt such considerations include, but are not limited to, the following: 
• 
The discovery of unexpected serious, or unacceptable risk to the subjects enrolled in the 
study 
• 
A decision on the part of Sponsor to suspend, discontinue, or shorten the study 
• 
Study conduct at the study site may warrant termination under conditions that include the 
following: 
• 
Failure of Investigator(s) to enroll eligible subjects into the study 
• 
Failure of Investigator(s) to comply with the Food and Drug Administration (FDA) 
regulations 
• 
Submission of false information from the research facility to Sponsor, the Clinical 
Monitor, or a regulatory authority 
• 
Insufficient adherence to protocol requirements 
• 
A conflict of interest of the Investigator, his/her institution, or site personnel that would 
negatively impact the integrity of the clinical trial 
• 
Institution or IRB under investigation for cause by a federal agency 
STUDY PROCEDURES 
All subjects will be followed for 2 years.  A subject is considered to have successfully completed the 
study upon completion of the 2 year visit (see Appendix B for the Schedule of Events). 
8.1. 
Screening Visit  
During the screening visit, the following procedures/assessments will be performed to determine subject 
eligibility: 
• 
Informed Consent prior to the conduct of any study-related procedures 
• 
Physical examination including vital signs (temperature, heart rate, respiratory rate, blood 
pressure), weight, height, BMI calculation (refer to Appendix H)  
• 
Medical and surgical history including ejection fraction data must be taken within the last 3 months 
to enroll in the study. 
• 
Patient history of heart failure hospitalizations in the 12 months previous to the baseline visit as 
documented in information provided by the patient’s cardiologist, internist, or referring physicians 
and review of all source documents of any heart failure hospitalization(s) reported in the previous 
year.   
• 
Demographics 

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• 
NYHA Functional Classification  
• 
Calculation of GFR (requires creatinine - refer to Appendix I) 
• 
Assessment of medications 
• 
Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) (refer to Appendix E) 
• 
Brief Illness Perception Questionnaire (refer to Appendix F) 
• 
Cardiac Health Security Survey (refer to Appendix G) 
• 
Assessment of enrollment eligibility (inclusion/exclusion criteria) 
The study coordinator or designee will administer patient-reported outcome questionnaires.  It is 
important that the subject understands the meaning of all words and instructions in each 
questionnaire and answers all the questions.  The subject will be instructed to ask any questions 
about the questionnaire if further explanation is needed.  The research coordinator or designee 
will review the questionnaires to verify that all questions have been answered.  The measures 
used will be the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12), the Brief Illness 
Perception Questionnaire, and the Cardiac Health Security Survey. The Patient Reported 
Outcomes will be obtained at screening and each follow up visit post implant (with the exception of the 1 
month follow-up visit) for 2 years. Patients who were enrolled in the study prior to addition of patient 
reported outcome questionnaires, and therefore did not complete baseline questionnaires, are not 
required to complete questionnaires at the follow-up visits. 
Eligible subjects will be scheduled for the Implant procedure.  Subjects on anticoagulation therapy (e.g. 
warfarin) may be instructed by the Investigator to discontinue use 1-2 days prior to pressure sensor 
placement.  The investigator should consider utilizing enoxaparin (Lovenox) per the site’s standard of 
care as bridge therapy to Sensor placement in subjects who were on anticoagulation therapy. 
For subjects at risk for gastro-intestinal bleeding during the period in which dual antiplatelet therapy is 
given, the investigator should consider a proton pump inhibitor such as omeprazole (Prilosec).  Subjects 
at risk include the elderly, those with a history of gastroduodenal ulcers, gastroesophageal reflux 
disease, esophagitis, intestinal polyps or cancer.  Subjects who smoke or who are using steroids or non-
steroidal anti-inflammatory drugs may also be at risk.  
8.2. 
Right Heart Catheterization and Implant Procedure (Baseline Visit)  
Before the RHC, the following procedures/assessments will be performed: 
• 
Abbreviated physical examination (i.e., vital sign assessments and significant changes since 
Screening Visit) and weight 
• 
Confirmation of enrollment eligibility (other than angiographic criteria) 
• 
PT/PTT with International Normalized Ratio (INR) of 1.5 or less for subjects previously on warfarin 
• 
Assessment of heart failure medications 
• 
Record any medical history updates since screening visit.  

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The patient will then undergo a standard RHC. A selective, hand injected pulmonary angiogram will be 
performed via the pulmonary artery catheter to identify a suitable pulmonary artery branch for sensor 
implantation. Subjects must have an appropriately sized (≥ 7mm diameter) pulmonary artery branch.  
Subjects who do not meet this inclusion criteria will not receive the PA Sensor implant and will be 
considered ineligible for the study.  These subjects will be documented as consented not implanted and 
will be followed for 30 days for safety.  Patients with a suitable target pulmonary artery branch will 
undergo: 
• 
Wireless implantable hemodynamic sensor implant  
• 
Pulmonary artery catheter measurements (pulmonary systolic, pulmonary diastolic, pulmonary 
mean, cardiac output) done 3 times consecutively with sensor measurements for setting of sensor 
baseline. 
• 
Provide post-procedure vascular access site care per standard procedure 
• 
At the Investigator’s discretion, subjects should be discharged once stable with respect to the 
procedure and their heart failure. 
• 
Please see User’s Manual for implant details 
Subjects who are currently on anticoagulant therapy (warfarin, or any FDA approved anticoagulant) will 
restart treatment.  The subject’s INR should be checked periodically to ensure that it is in the therapeutic 
range.  Those subjects not on chronic warfarin will be placed on anticoagulant/antiplatelet therapy as 
indicated in the device User’s Manual. Refer to the User’s Manual for further details.   
8.3. 
Study Follow-Up Visits 1, 2, 3, 4, and 5 (Months 1, 6, 12, 18, and 24)  
Implanted subjects will be evaluated at Month 1 (± 7 days) and at Months 6, 12, 18, and 24 (± 30 days) 
and the following procedures/assessments will be performed: 
• 
Updated medical and surgical history 
• 
Assessment of AEs that occurred since the last visit 
• 
Abbreviated physical examination (significant changes since previous visit) including vital signs 
(heart rate, respiratory rate, blood pressure), and weight  
• 
Assessment of NYHA functional class 
• 
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) 
• 
Brief Illness Perception Questionnaire 
• 
Cardiac Health Security Survey  
• 
Heart failure medication review 
• 
PA pressure measurements may be obtained at the Investigator’s discretion 

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Subjects will be reminded to obtain pulmonary artery pressure measurements utilizing the CardioMEMS 
HF System as directed.  Subjects will be reminded of the current ACC/AHA guidelines regarding sodium 
and fluid restrictions.   
The study coordinator or designee will administer patient-reported outcome questionnaires.  It is 
important that the subject understands the meaning of all words and instructions in each 
questionnaire and answers all the questions.  The subject will be instructed to ask any questions 
about the questionnaire if further explanation is needed.  The research coordinator or designee 
will review the questionnaires to verify that all questions have been answered.  The Patient 
Reported Outcomes will be obtained at 6, 12, 18 and 24 months. Patients who were enrolled in the 
study prior to addition of patient reported outcome questionnaires, and therefore did not complete 
baseline questionnaires, are not required to complete questionnaires at the follow-up visits. 
8.4. 
Subject Home PA Pressure Readings 
Prior to hospital discharge, subjects will be instructed on how to take their own pulmonary artery 
pressure measurements, utilizing the CardioMEMS HF System.  Subjects will provide returned 
demonstration on: setting up the unit, connecting the system to a phone line, proper positioning for 
obtaining the optimum sensor signal, taking and transmitting the daily pressure measurements.  The unit 
will transmit the data to a database using the system’s modem.  
The home measurements will be taken while the subject is lying down (supine) in bed positioned on a 
padded, flat antenna. It is recommended that subjects obtain home measurements in a supine position 
however, if the subject is unable to lie flat, measurements can be obtained in a sitting or reclined 
position.  It is important the anatomical position is consistent for every measurement.   
The home electronics system is small enough for placement on a bedside table.  The unit will provide 
audio and visual prompts for the subject to guide them through signal acquisition.  Once the subject is 
positioned and a signal is acquired, the subject will be notified of the successful reading and the data is 
automatically transmitted to a remote database.  St. Jude Medical will provide instructions for use and a 
help line will be available.  Please refer to subject’s Patient System Guide for more detailed information. 
8.5. 
PA Pressure Readings in the Hospital  
If a subject is hospitalized, seen in the emergency room (ER) or has a clinic visit, the CardioMEMS HF 
System may be used to obtain pulmonary artery pressure measurements at the investigators discretion.   
Following sensor implant, subsequent RHC procedures or pulmonary artery catheter insertions must be 
performed under fluoroscopic guidance.   
Resetting of the sensor baseline will be performed as deemed necessary by Sponsor.  Baseline resetting 
may require an echocardiogram or a RHC procedure. 
Following the sensor implant, should a RHC procedure or PA catheter evaluation be clinically warranted, 
comparative pulmonary artery pressures utilizing the CardioMEMS HF System should also be obtained 
utilizing the hospital electronics unit.   
8.6. 
Criteria for Withdrawal 
Subjects may be withdrawn from the study for any of the following reasons: 
1. Subject withdraws his/her consent 
2. Investigator determines that other treatment is warranted to protect the health and safety of the 
subject  

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3. Investigator determines that the subject is noncompliant with study related procedures  
4. Subject is lost to follow-up:  site must document attempts made to contact the subject for an early 
discontinuation visit (e.g., 2 – 3 phone calls, followed by 1 certified letter, documentation of repetitive 
missed study visits, etc.) 
The Investigator will notify the Sponsor and document on the appropriate case report form (CRF) the 
reason/circumstances for early discontinuation. All subjects who withdraw from the study should have the 
following study exit procedures performed if possible: 
• 
Updated medical and surgical history 
• 
Assessment of AEs that occurred since the last visit 
• 
Abbreviated physical examination (only significant changes since Enrollment) including vital signs 
(temperature, heart rate, respiratory rate, blood pressure), and weight  
• 
Assessment of NYHA functional class 
• 
Kansas City Cardiomyopathy Questionnaire(KCCQ-12) 
• 
Brief Illness Perception Questionnaire 
• 
Cardiac Health Security Survey  
• 
Heart failure Medication Review 
• 
PA pressures may be obtained at the Investigator’s discretion  
All reasonable efforts should be made to retain subjects in the clinical trial until its completion.  If a 
patient moves from the geographic area of their investigator, St. Jude Medical will attempt to place the 
patient with another investigator.  
8.7. 
Deviations from CIP 
A deviation is defined as an instance(s) of failure to follow, intentionally or unintentionally, the 
requirements of the CIP. The investigator should not deviate from the CIP. 
In some cases, failure to comply with the CIP may be considered failure to protect the rights, safety and 
well-being of subjects; such non-compliance exposes subjects to unreasonable risks. Examples: failure 
to adhere to the inclusion/exclusion criteria, failure to report SAEs within given timeframe as per CIP, etc. 
Investigators should seek to minimize such risks by adhering to the CIP. 
The PI must maintain accurate, complete, and current records, including documents showing the date of 
and reason for each deviation from the CIP. Relevant information for each deviation will be documented 
as soon as possible on the applicable CRF. The site will submit the CRF to the Sponsor. 
The PI is required to adhere to local regulatory requirements for reporting deviations to the site IRB. 
SAFETY ANALYSES 
9.1. 
Primary Safety Endpoints 
Primary safety endpoints will be evaluated at 2 years: 
1) Freedom from device/system related complications 

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2) Freedom from pressure sensor failure 
9.1.1. Device / System-related Complication Criteria 
A device / system-related complication is an adverse event that is, or is possibly, related to the system 
(wireless pressure sensor or external electronics) and has at least one of the following characteristics:  
• is treated with invasive means (other than intramuscular medication or a right heart catheterization 
which is used for diagnostic purposes) 
• results in the death of the subject 
• results in the explant of the device 
9.1.2. Sensor Failure Criteria 
A Sensor failure occurs when no readings can be obtained from it after troubleshooting the system to 
rule out any problems with the external electronics. 
EFFECTIVENESS ANALYSES 
10.1. Primary Effectiveness Endpoint  
• 
The primary effectiveness endpoint will compare the annualized HF hospitalization rate at 1 year 
in the study to the HF hospitalization rate in the year prior to enrollment. 
10.2. Supplemental Analyses  
10.2.1. Mortality 
The mortality rate at 1 year in study will be analyzed. 
10.2.2. HF Hospitalization or Death 
The annualized HF hospitalization or death rate at 1 year in the study will be compared to the HF 
hospitalization rate in the year prior to enrollment.   
10.2.3. Patient Compliance  
Patient device usage over the course of the trial will be examined.  
10.2.4. Training Evaluation 
The effectiveness of the training program will be examined by community and academic hospitals. 
10.2.5. Subgroup Analyses 
The effectiveness analyses will be evaluated in each of the following subgroups: Women, Men, 
Reduced Ejection Fraction (< 40%), Preserved Ejection Fraction (≥ 40%), Ischemic Etiology, Non-
ischemic Etiology, With ICD/CRT-D, and Without ICD/CRT-D.   
10.2.6. 
Quality of Life Evaluations 
Patient reported outcomes will be evaluated using Quality of Life Questionnaires.  The measures 
used will be the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12), the Brief Illness 
Perception Questionnaire, and the Cardiac Health Security Survey.   
ADVERSE EVENTS 

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11.1. Adverse Event (AE) 
An AE is any untoward medical occurrence (e.g., noxious or pathological changes) in a subject compared 
with pre-existing conditions that may occur during any part of the clinical study. An AE is defined as 
being independent of assumption of any causality (e.g., primary or concomitant disease or study design).  
AEs should be evaluated by the Investigator and maintained in the research records at the site.  AEs 
should be reported to the Sponsor on a CRF. 
11.2. Serious Adverse Event (SAE) 
For this study, an SAE is defined as any untoward medical occurrence that:  
• results in death 
• is immediately life-threatening – an event in which the subject was at risk of death at the time of the 
event 
• requires admission and hospitalization (> 24 hours) or prolongation of existing hospitalization 
• results in disability/incapacity 
• results in a congenital anomaly/birth defect 
• requires intervention to prevent one of the above 
SAEs, as determined by the Investigator, must be reported to the Sponsor.   
The cause of death of any subject after enrollment must be documented on the AE CRF and reported as 
an SAE.  The information should include the date expired, cause of death, and what attempts were made 
to treat the condition.  
If it is not certain that an event meets the above definition, contact the Project Manager. 
11.3. Device-Relatedness 
An AE or SAE that is definitely or possibly related to the device or the insertion procedure should be 
considered device-related.  A serious adverse device effect (SADE) is an event that meets any of the 
above SAE criteria and is considered related to the device or the insertion procedure by the Investigator.  
All other events considered related to the device or insertion procedure are non-serious adverse device 
effects (ADEs). 
If it is not certain that an event meets the above definitions, contact the Project Manager.  
11.4. Procedures for Reporting Adverse Events (AEs) 
It is the responsibility of the Investigator or Sub-Investigator(s) to perform periodic assessments of all 
AEs as well as identifying SAEs.  Safety surveillance and reporting starts as soon as the patient is 
enrolled in the clinical investigation. Safety surveillance and reporting will continue until the last follow-up 
visit has been performed, the subject is deceased, the subject concludes participation in the clinical 
investigation or the subject withdraws from the clinical investigation.  
AEs, ADEs, SAEs and SADEs that occur during the study should be treated by established standards of 
care that will protect the life and safety of the subjects.   
Any AEs/ADEs are to be reported as soon as possible after knowledge of the event. SAEs/SADEs must 
be reported to the Sponsor no later than 3 calendar days from the day the site personnel became aware 
of the event or as per the investigative site’s local requirements, if the requirement is more stringent than 

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3 calendar days. If an SAE/SADE is not reported within the required time, it will be considered a protocol 
deviation. The date the site staff became aware of an event meeting the criteria of an SAE must be 
recorded in the source documentation.  
The Sponsor will ensure that all applicable events and device deficiencies are reported to the relevant 
authorities as per regulations. The sites should notify the Sponsor of reportable AEs by creating and 
saving the applicable CRF within the electronic data capture (EDC) system. The description of the AE, 
date of the AE, treatment and resolution of the AE will be reported, as applicable per regulations, to the 
relevant authorities. Additional information may be requested, when required, by the Sponsor in order to 
support the reporting or adjudication of AEs. The Investigator must notify the IRB, if appropriate, in 
accordance with national and local laws and regulations, of the AEs reported to the Sponsor. Additional 
information with regard to an adverse event should be updated within the appropriate CRF. 
11.5. Criteria and Guidelines for Non-reportable Events 
The following events are not reportable to the Sponsor: 
• 
Symptoms of previously reported events and/or scheduled procedures, such as: 
- 
Cataract surgery 
- 
Colonoscopy 
- 
Flaring of gout (when gout is already reported/pre-existing condition) 
- 
Symptoms of HF (when primary HF is already reported) 
11.6. Anticipated Adverse Events  
11.6.1. Anticipated AEs 
Events associated with the CardioMEMS™ PA Sensor or the implant procedure (in conjunction 
with RHC) or post-implantation complications are considered anticipated and include the following: 
• 
Infection 
o Upper respiratory infection 
o Bronchitis 
o Pneumonia 
o Acute Bronchitis 
o Groin abscess 
o Methicillin-resistant staphylococcal aureus infection 
o Pulmonary Infiltration 
o Sepsis 
• 
Arrhythmias  
o Ventricular tachycardia 
o Atrial fibrillation 
o Ventricular arrhythmia 
o Ventricular fibrillation 
o Atrial fibrillation with rapid ventricular response 
o Atrial flutter 
o Cardiac dysrhythmias 
o Tachycardia 
o Wide complex tachycardia  
• 
Bleeding 
o Epistaxis 

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o Hemoptysis 
o GI bleed 
o Bleeding 
o Blood in stool 
o Catheter site bleeding 
o Catheter site ecchymosis 
o Hematuria 
o Nose bleeds  
• 
Hematoma 
o Hematoma 
o Catheter site hematoma 
o Vessel puncture site hematoma 
• 
Thrombus 
o Arterial thrombosis (limbs) 
o Blood clot 
• 
Myocardial infarction 
• 
Transient ischemic attack 
• 
Stroke 
• 
Death 
• 
Sensor embolization  
• 
Pulmonary artery perforation 
11.6.2. Anticipated ADEs/SADEs 
The following is a list of possible anticipated ADEs/SADEs: 
• 
Hemoptysis  
• 
Sensor not deploying 
• 
Transient ischemic attack 
• 
Atypical chest pain 
• 
Sepsis leading to death 
• 
Atrial arrhythmia leading to death 
• 
Arterial embolism (upper extremity) 
• 
PA (in-situ) thrombus 
• 
Catheter site bleeding 
• 
Catheter site ecchymosis 
• 
Catheter site hematoma 
• 
Vessel puncture site pain 
• 
Cardiac monitoring abnormal 
• 
Heart rate irregular 
• 
Serum creatinine increased 
• 
Dyspnea 
• 
Congestive HF 
• 
Ventricular tachycardia 
• 
Dizziness 
• 
Vessel perforation  
• 
Sensor failure/malfunction 
• 
Sensor migration 

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• 
System not transmitting 
 
Refer to the CardioMEMS™ PA Sensor and Delivery Catheter, Model CM2000 User Manual for more 
information. If it is not certain that an event meets the above definitions, contact the Project Manager.  
For unexpected failure modes or unexpected adverse events, the site should follow their standard 
reporting practices for medical device reporting (MDR). As defined in 21 CFR 803, a MDR reportable 
event (or reportable event) means: An event that device user facilities become aware of that reasonably 
suggests that a device has or may have caused or contributed to a death or serious injury.  A device user 
facility must report to sponsor and the FDA (no later than 10 days after awareness date) deaths and 
serious injuries that a device has or may have caused or contributed to, establish and maintain adverse 
event files, and submit summary annual reports to FDA. 
STATISTICAL ANALYSIS 
The data will be summarized using univariate statistics (e.g., N, mean, standard deviation, median, 
minimum and maximum) or frequency (e.g., N, %) as appropriate. 
The primary time point for safety analyses is 24 months post enrollment.  Enrollment is defined as having 
a successful Sensor implant.  The primary time point for effectiveness analyses is 12 months post 
enrollment.   
Unless otherwise specified, all statistical tests will be 2-sided with a significance level of 0.05. 
12.1. Populations for Analysis 
Safety Population:  The Safety Population consists of all subjects who received a Sensor implant or 
underwent the implant procedure but were never implanted, regardless of study completion status.  All 
safety analyses will be performed on the Safety population. 
Subjects who are found not to have an appropriately sized pulmonary artery branch and did not receive 
the Sensor implant will be considered ineligible for the study.  However, these subjects will be followed 
for 30 days for safety and all safety related data for these subjects will be provided.   
Effectiveness Population:  The effectiveness population consists of all subjects who received a Sensor 
implant regardless of study completion status.  All effectiveness analyses will be performed on the 
effectiveness population. 
12.2. Sample Size Considerations 
Effectiveness Sample Size Determination 
For the primary effectiveness endpoint of HF hospitalization rate during 1 year, 300 patients will provide 
greater than 90% power to meet the efficacy goal (upper confidence limit less than the HF hospitalization 
rate in the year prior to enrollment), using a one-sample, two-sided Poisson confidence interval with 
alpha of 0.05.   
Safety Sample Size Determinations 
For the two-year primary safety endpoint of freedom from device-related complications, using an exact 
two-sided test for one-sample binomial proportions with alpha of 0.05, a sample size of 619 subjects will 
provide greater than 90% power to detect a difference as small as 5% from the null proportion rate of 
0.80 (i.e., objective performance criterion of 80%).  For sensor failures at 2 years, a sample size of 663 
subjects provides greater than 90% power to detect a difference as small as 3.5%  from the null 
proportion rate of 0.90 (i.e., objective performance criterion of 90%).  

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Thus, the sample size for this study is driven by the safety endpoints.  The 2 year attrition rate in 
CHAMPION was 49.1% (228/550).  To ensure sufficient patients are enrolled to adequately evaluate 
safety and efficacy, 1200 subjects will be enrolled.   
Note that at least 35% of the 1200 enrolled patients (420) must be women resulting in approximately 206 
women completing the trial (assuming a 49% attrition rate).  This sample size will provide greater than 
90% power to meet the goal for effectiveness.  Regarding freedom from device-related complications 
and freedom from sensor failures, 206 women will provide greater than 90% power to detect a difference 
as small as 0.06 from the null proportion rate of 0.90. 
12.3. Missing Data 
Missing data will be tracked in the Electronic Data Capture system; queries will be generated and 
provided to the site.  In addition, a St. Jude Medical representative, or designee will routinely perform 
monitoring visits at each site.  During the monitoring visits, missing data queries will be addressed until 
resolution.  Missing data that are not resolved will not be imputed unless specified in the sections below.  
12.4. Subject Accountability and Baseline Information 
Descriptive summaries will be generated to describe the disposition of all enrolled subjects.  
12.5. Demographic and Baseline Information 
Descriptive summaries will be generated for all relevant baseline variables.  These variables include, but 
are not limited to, demographic data and conditions at the time of enrollment.  
12.6. Safety Analyses 
The safety analyses will be performed using the Safety Population.  The data will be summarized using 
univariate statistics (e.g., N, mean, standard deviation, median, minimum and maximum) or frequency 
(e.g., N, %) as appropriate. 
12.6.1. Primary Safety Endpoints 
The primary safety analyses will be based on the following objective performance criteria: a) the lower 
limit of the two-sided 95% confidence interval on the freedom from device / system-related complication 
rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on 
the freedom from pressure sensor failure rate at 24 months is greater than 90%.  These primary safety 
endpoints will be tested hierarchically in order to control for multiplicity.  First, the freedom from device / 
system-related complication rate will be tested.  If the result is statistically significant (i.e., p<0.050), then 
the freedom from pressure sensor failure rate will also be tested for significance (i.e., p<0.050).  The 
study will be judged to have provided positive safety results if both tests of the primary safety analysis 
endpoints are statistically significant (i.e., p<0.050).   
Mathematically stated, the primary safety hypotheses are: 
a) H0: P (Freedom from device / system-related complications at 24 months) ≤ 80% 
Ha: P (Freedom from device / system-related complications at 24 months) > 80% 
 
b) H0: P (Freedom from pressure sensor failure at 24 months) ≤ 90% 
Ha: P (Freedom from pressure sensor failure at 24 months) > 90% 
Plotting and analysis of safety endpoints will also be displayed using Kaplan-Meier methods. 

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Safety will also be assessed throughout the study by the frequency of Adverse Events (AEs), Adverse 
Device Effects (ADEs), Serious AEs (SAEs), and Serious Adverse Device Effects (SADEs), and device / 
system-related complications by relationship to the device via Medical Dictionary for Regulatory Activities 
(MedDRA) system organ classification.  Physical examination, and subject survival data through 24 
months will be tabulated across study period assessments.    
12.7. Effectiveness Analyses 
Effectiveness analyses will be conducted in the effectiveness population. The data will be summarized 
using univariate statistics (e.g., N, mean, standard deviation, median, minimum and maximum) or 
frequency (e.g., N, %) as appropriate. 
12.7.1. Primary Effectiveness Endpoint 
The primary time point for analyses is 12 months post-enrollment.  The primary effectiveness endpoint 
will compare the annualized HF hospitalization rate parameter, γ, at 1 year versus the HF hospitalization 
rate in the year prior to enrollment  using a two-sample, two-sided Poisson confidence interval.  If the 
two-sided, upper 95% confidence interval for the PAS rate parameter is less than that in the year prior to 
enrollment, then the primary effectiveness endpoint will be met.   
Mathematically stated, the primary effectiveness hypothesis is: 
H0:  (12 month HF Hospitalization Rate) ≥  (HF hospitalization rate in year prior to enrollment) 
Ha:  (12 month HF Hospitalization Rate) <  (HF hospitalization rate in year prior to enrollment) 
where  (12 month HF Hospitalization Rate) = the HF hospitalization rate parameter at 1 year in the PAS and  (HF 
hospitalization rate in year prior to enrollment) = the HF hospitalization rate in the year prior to enrollment. 
12.7.2. Supplemental Analyses 
Mortality 
The mortality rate over 1 year in study will be reported. Plotting and analysis of survival data will be 
displayed using Kaplan-Meier methods. 
HF Hospitalization or Death 
The annualized HF hospitalization or death rate parameter, λ, at 1 year will be compared to the HF 
hospitalization rate in the year prior to enrollment  using a two-sample, two-sided Poisson confidence 
interval.  If the two-sided, upper 95% confidence interval for the PAS rate parameter is less than that in 
the year prior to enrollment, then the hypothesis will be met.   
Mathematically stated, the hypothesis is: 
H0: λ (12 month HF Hospitalization or Death Rate) ≥ λ (HF hospitalization rate in year prior to enrollment) 
Ha: λ (12 month HF Hospitalization or Death Rate) < λ (HF hospitalization rate in year prior to enrollment) 
where λ (12 month HF Hospitalization or Death Rate) = the HF hospitalization or death rate parameter at 1 year in the 
PAS and λ (HF hospitalization rate in year prior to enrollment) = the HF hospitalization rate in the year prior to enrollment. 
Patient Compliance 
Patient device usage over the course of the trial will be examined.  The total number of PA pressure 
readings taken will be reported as a percentage of patient days at home.  

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Training Evaluation 
To assess the effectiveness of the training program, the safety and effectiveness results will be reported 
for: 
1) Academic Hospitals 
2) Community Hospitals 
Subgroup Analyses  
The effectiveness analyses will be evaluated in each of the following subgroups:   
1) Women 
2) Men 
3) Reduced Ejection Fraction (< 40%) 
4) Preserved Ejection Fraction (≥ 40%) 
5) Ischemic Etiology 
6) Non-ischemic Etiology 
7) With ICD/CRT-D 
8) Without ICD/CRT-D 
Quality of Life Evaluations 
Patient improvement in Quality of Life will be reported.  The difference between the Quality of Life scores 
at 6 months, 12 months, 18 months, and 24 months will be compared to the baseline values using 
general linear mixed models.  Quality of Life will be measured using the Kansas City Cardiomyopathy 
Questionnaire-12 (KCCQ-12), the Brief Illness Perception Questionnaire, and the Cardiac 
Health Security Survey. 
PAS SUB-STUDY  
This section describes the design, hypotheses, populations, endpoints and analysis of the PAS sub-
study.  All other sections of the protocol pertain to the main PAS cohort unless specifically stated 
otherwise. 
13.1. Sub-study Design  
This is a prospective/retrospective multicenter single arm sub-study within the main PAS cohort. 
13.2. Sub-study Hypotheses 
 
The safety hypotheses are: 
a) H0: P (Freedom from device / system-related complications at 24 months) ≤ 80% 
Ha: P (Freedom from device / system-related complications at 24 months) > 80% 
b) H0: P (Freedom from pressure sensor failure at 24 months) ≤ 90% 
Ha: P (Freedom from pressure sensor failure at 24 months) > 90%  
The effectiveness hypothesis is: 
H0: ϒ (12 month heart failure [HF] Hospitalization Rate) ≥ ϒ (12 month HF Hospitalization Rate in CHAMPION trial Control group) +  

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Ha: ϒ (12 month HF Hospitalization Rate) < ϒ (12 month HF Hospitalization Rate in CHAMPION trial Control group) +  
where ϒ (12 month HF Hospitalization Rate) = the HF hospitalization rate parameter at 1 year in the 
PAS, ϒ (12 month HF hospitalization rate in CHAMPION trial Control group) = the HF hospitalization rate 
in Part 1 of the premarket Control group, and   = non-inferiority (NI) margin of 0.10.  The CHAMPION 
study Part 1 Control group had a HF hospitalization rate of 0.75 with a lower 95% confidence limit of 
0.64.  Therefore, a NI margin of 0.10 was chosen to account for the typical variability in HF 
hospitalization rates occurring between clinical trials.  If the null hypothesis is rejected, it can be 
concluded that there was not a worsening in HF hospitalization rate in the PAS compared to the 
CHAMPION study Control group (i.e. non-inferiority is established). 
13.3. Sub-study Population (device and control group)  
These patients must be selected by an independent committee to be clinically similar to the CHAMPION 
study Control cohort and will be selected from the PAS Main Cohort. 
The independent committee will identify optimally medicated adults from the main cohort with New York 
Heart Association (NYHA) Class III Heart Failure (HF) who have experienced a HF hospitalization within 
the past 12 months. This will be based on pre-enrollment information, and not on any information 
regarding what happened to the patient post-enrollment. 
Efforts should be taken to have a fair representation of women (actual number not set as there may be 
unknown biases regarding optimal medication for women and men). 
The Control patients from Part 1 of the CHAMPION study will set the performance goal.  
13.4. Sub-study Sample Size  
The Control group HF hospitalization rate for Part 1 of the CHAMPION study at 1 year was 0.75.   
Using an exact one-sample, 2-sided Poisson 95% confidence interval with alpha of 0.05, 114 patients will 
provide 85% power to show a difference between the estimated Treatment rate of 0.52 and the Control 
rate of 0.75. Likewise, 130 patients are required to achieve 90% power to show a difference between the 
estimated Treatment rate of 0.52 and the Control rate of 0.75. 
The 2 year attrition rate in CHAMPION was 49.1%, therefore 256 patients (130/(100%-49.1%) = 256) is 
the minimum sample size for this analysis.  However, the Independent Committee will identify all patients 
that are optimally managed and are clinically similar to the Control group in CHAMPION.  Therefore, the 
eligible patients for this sub-cohort and the resultant sample size may be greater.   
13.5. Sub-study Endpoints 
 
13.5.1. Sub-study Safety Endpoints   
Safety endpoints will be evaluated at 2 years: 
1) Freedom from device/system related complications compared to OPC of 0.80 
2) Freedom from pressure sensor failure compared to OPC of 0.90 
13.5.2. Device / System-related Complication Criteria 
A device / system-related complication is an adverse event that is, or is possibly, related to the system 
(wireless pressure sensor or external electronics) and has at least one of the following characteristics:  
• is treated with invasive means (other than intramuscular medication or a right heart catheterization 

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which is used for diagnostic purposes) 
• results in the death of the subject 
• results in the explant of the device 
13.5.3. Sensor Failure Criteria 
A Sensor failure occurs when no readings can be obtained from it after troubleshooting the system to 
rule out any problems with the external electronics. 
13.5.4. Sub-study Effectiveness Endpoint  
Heart failure (HF) hospitalization rate over 1 year in the PAS study compared to the 1 year HF 
hospitalization rate in Part 1 of the CHAMPION study Control cohort. 
13.5.5. Sub-study Supplemental Analyses 
Training Evaluation 
To assess the effectiveness of the training program, the safety and effectiveness results will be reported 
for: 
1) Academic Hospitals 
2) Community Hospitals 
Subgroup Analyses  
The effectiveness analyses will be evaluated in each of the following subgroups:   
1) Women 
2) Men 
3) Reduced Ejection Fraction (< 40%) 
4) Preserved Ejection Fraction (≥ 40%) 
5) Ischemic Etiology 
6) Non-ischemic Etiology 
7) With ICD/CRT-D 
8) Without ICD/CRT-D 
13.6. Sub-study Enrollment Plan 
 
These patients must be selected by an Independent Committee to be clinically similar to the CHAMPION 
study Control cohort and will be selected from the main cohort of the PAS. 
13.7. Sub-study Length of Follow-up  
The follow-up length for the PAS will be 24 months. 
13.8. Sub-study Frequency of Follow-up Assessments  

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Follow-up assessments will be made at Month 1, Month 6, and every 6 months thereafter for 2 years.  
Follow-up visits will include a physical exam, evaluation of NYHA Class, AE assessment, heart failure 
medications review, and assessment of any hospitalizations that may have occurred between visits. 
13.9. Sub-study Statistical Plan 
 
13.9.1. Analysis of Sub-study Safety Endpoints  
The safety analyses will be based on the following objective performance criteria:  
a) the lower limit of the two-sided 95% confidence interval on the freedom from device / system-related 
complication rate at 24 months is at least 80%, and  
b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure 
rate at 24 months is at least 90%.   
These safety endpoints will be tested hierarchically in order to control for multiplicity.  First, the freedom 
from device / system-related complication rate will be tested.  If the result is statistically significant (i.e., 
p<0.05), then the freedom from pressure sensor failure rate will also be tested for significance (i.e., 
p<0.05).  The study will be judged to have provided positive safety results if both tests of the safety 
analysis endpoints are statistically significant (i.e., p<0.05).   
13.9.2. Analysis of Sub-study Effectiveness Endpoints  
The effectiveness evaluation will compare the annualized HF hospitalization rate at 1 year to the 1 year 
HF hospitalization rate in Part 1 of the CHAMPION trial Control patients.  The estimate of the rate will be 
tested with a NI margin of 0.10 and presented with 95% Poisson confidence intervals.  
13.9.3. Schematic Diagram of the Sub-study and Main PAS Study 
See Appendix M for a schematic diagram of the Main PAS Study and the PAS Sub-study. 
REPORTING OF INTERIM AND PRIMARY ANALYSES 
In addition to the primary safety and effectiveness analyses, updates from the PAS will be submitted to 
FDA as a PMA supplement every 6 months for the first two years of the study (annually thereafter) and 
updated in the device labeling.  This information will include the following: study enrollment and follow-up 
status; demographic information; safety and effectiveness results; mortality; serious adverse events; 
days alive outside of the hospital for heart failure; patient compliance; sensor performance; and 
medication changes in response to PA pressure.  Please refer to Appendix L: Reporting of Interim 
Analyses. 
The primary safety analyses will be reported after all patients complete 24 months post enrollment or 
discontinue early.  The primary effectiveness analyses will reported after all patients complete 12 months 
post enrollment or discontinue early. 
CLINICAL EVENTS COMMITTEE 
An independent clinical events committee (CEC) will be formed to review clinical data. The committee 
will be comprised of physicians, who will not participate in the enrollment or treatment of subjects in this 
trial.  All endpoints or suspected endpoints will be reviewed by this committee according to the CEC 
Committee charter.  Any event listed in the CEC Committee charter reported in an SAE report or the 
CRF will trigger the accumulation of a portfolio of pertinent documents from the hospital admission.  
These documents will be collected and copies distributed to members of the CEC Committee.  The 

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interpretation of the event as classified and adjudicated by the clinical events committee will be used in 
the final effectiveness and safety analyses. 
The composition and function of the CEC Committee is described in Appendix K.   
DATA COLLECTION, STUDY MONITORING, AND DATA DISCLOSURE  
16.1. Data Collection and Reporting 
Electronic CRFs (eCRFs) will be utilized.  Site staff will enter the information required by the protocol 
onto eCRFs using a validated St. Jude Medical system that conforms to FDA requirements for electronic 
data capture.  All data fields will be completed where appropriate.  However, if data are not available 
(i.e., missed visit, etc.), the site will receive instruction regarding electronic documentation.  As data are 
entered, automated cross-check programs will search for any data discrepancies in the eCRFs.  
Appropriate error messages will be generated, allowing for the modification or verification of the entered 
data.  Queries will generally be sent to the study site using an electronic data query system that includes 
an automated audit trail of the corrections.   
Monitoring personnel of St. Jude Medical, or its designee, will review the eCRFs for completeness and 
accuracy and will instruct site personnel to make any corrections or additions.  The Investigator, or 
designee, will certify that the data are complete and accurate by applying an electronic signature to the 
eCRF.  Any subsequent alterations, corrections, or additions will be reviewed and electronically signed 
by the Investigator prior to database lock. 
16.2. Site Qualification 
For sites that did not participate in the CHAMPION protocol, a site visit will be performed by St. Jude 
Medical or designee prior to the start of the study to review the protocol in detail, to ensure the availability 
of appropriate trial personnel, adequate resources and to assess their ability to properly conduct the 
study according to ICH-GCP guidelines and local requirements. 
16.3. Training 
Detailed training to cover aspects of the hemodynamic management of heart failure (HF), identification of 
prospective patients, HF sensor implant procedures, the use of the heart failure electronic units and the 
use of the CardioMEMS HF website to view the patient’s hemodynamic parameters will occur for all sites 
prior to enrollment of patients. 
The CardioMEMS HF System training program is comprised of specific modules designed to provide 
essential didactic and field training.   Each module consists of training materials, reference information, 
checklists, and training documentation forms.  Training materials used will include equipment 
demonstrations, PowerPoint presentations, manuals, posters, brochures, and videos.  
The training may be carried out in any sequence.  Specific requirements for certification are defined 
within each module. The five training modules are: 
Module 1: Hemodynamic Management of Heart Failure   
Module 2: CardioMEMS™ HF Sensor Implant Procedure  
Module 3: CardioMEMS™ HF Electronic Systems  
Module 4: CardioMEMS™ HF Website  
Module 5: Patient Training  
Didactic and hands-on training on an anatomic model will be provided before the first Sensor implant. St. 
Jude Medical representative will be present during the first 3 Sensor implant procedures at each site.  

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After successful completion of implant training, the Investigator will receive documentation of training.  
Following the required training, a St. Jude Medical representative will be available to support the site staff 
with additional training needs as necessary. 
A Sensor implant identification card will be provided to the patient following the implant procedure.  This 
card will include the date of the Sensor implant and the location of the Sensor.   Prior to discharge, the 
patient will be trained on taking their pulmonary artery pressures at home utilizing the CardioMEMS HF 
System. Subjects will be instructed to take PA sensor pressure measurements daily or as instructed by 
their physician.  Subjects will be reminded of the current ACC/AHA guidelines regarding sodium and fluid 
restrictions. Patients will be instructed to contact a St. Jude Medical technical support representative if 
they are having any problems using the CardioMEMS HF System.   
The Investigator and/or designee will be trained on use of the CardioMEMS HF Patient Database for the 
first 3 patients. Investigators will demonstrate knowledge of hemodynamic management of heart failure 
and will be provided documentation of training.  Investigators or designee may contact a St. Jude 
Medical representative if they have any questions regarding the CardioMEMS HF System. 
16.4. Study Monitoring 
St. Jude Medical or designee will monitor the study to meet the sponsor’s monitoring Standard Operating 
Procedures (SOPs), ICH-GCP guidelines, and applicable regulatory requirements and to ensure that 
study initiation, conduct, and closure are adequate. 
Clinical Monitors will periodically audit CRFs/eCRFs and corresponding source medical records for each 
subject.  The monitoring visits provide the Sponsor with the opportunity to evaluate the progress of the 
study, to verify the accuracy and completeness of CRFs/eCRFs, to resolve any inconsistencies in the 
study records, and to assure that all protocol requirements, applicable regulatory or country-specific 
regulations, other requirements, and Investigator’s obligations are being fulfilled. 
The Investigator and his/her staff will be expected to cooperate with St. Jude Medical personnel or 
agents of St. Jude Medical and to be available during the monitoring visits to answer questions 
sufficiently and to provide any missing information. 
The Investigator(s)/institution(s) will permit direct access to source data/documents for trial-related 
monitoring, audits, IRB and regulatory inspection(s). 
16.5. Source Data Verification 
Source data verification ensures accuracy and credibility of the data obtained.  During monitoring visits 
reported data are reviewed with regard to being accurate, complete, and verifiable from source 
documents (e.g., subject files, physician notes, discharge summaries, operative records, etc.).   
16.6. Definition of Source Data 
Source data includes all information in source documents (original records, certified copies of original 
records, and original data recorded on customized worksheets) and includes all original recordings or 
certified copies of clinical findings, observations, or other activities in a clinical trial necessary for the 
reconstruction and evaluation of the trial.  
16.7. Data Disclosure and Subject Confidentiality 
Subject medical information obtained as a result of this study is considered confidential and disclosure to 
third parties other than those noted below is prohibited.  All reports and communications relating to 
subjects in this study will identify each subject only by their initials and number.  Medical information 
resulting from a subject’s participation in this study may be given to the subject’s personal physician or to 

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the appropriate medical personnel responsible for the subject’s welfare.  Data generated as a result of 
this study are to be available for inspection upon request by FDA or other government regulatory agency 
auditors, the Sponsor and the IRB. 
The information developed in this clinical study will be used by the Sponsor in the clinical development of 
the study device and therefore may be disclosed by the Sponsor as required for disclosure as to other 
clinical Investigators, to other companies, to the FDA and to other government agencies. 
ETHICAL CONSIDERATIONS AND STUDY ADMINISTRATION 
17.1. Human Subjects Protection 
Subject’s informed consent has to be obtained and documented in accordance with local regulations, 
ICH-GCP requirements, and the ethical principles that have their origin in the principles of the 
Declaration of Helsinki. 
Before initiation of this study, the Investigator or designee and the Sponsor will jointly develop the 
consent form.  Written IRB approval of the protocol and the consent form must be provided to the 
Sponsor prior to enrollment of subjects. This approval must refer to the consent form and to the study 
title and protocol number as given by the Sponsor on the cover page of the protocol. 
Prior to participation in the study, the written informed consent form must be signed and personally dated 
by the subject, or his/her legal representative, and by the person who conducted the informed consent 
discussion (Investigator or designee). The subject or his/her legal representative must receive a copy of 
the signed and dated informed consent form. As part of the consent process, each subject must consent 
to direct access to his/her medical records for trial-related monitoring, auditing, IRB review, and 
regulatory inspection. 
The informed consent form should be updated or amended whenever new information becomes 
available that may be relevant to the subject. The subject should then sign the revised informed consent 
form as directed by the IRB. 
A list of IRB voting members, their titles or occupations, and their institutional affiliations or a federal wide 
assurance number should be provided to the Sponsor before study initiation.   
The IRB must be notified of completion of the study and a final report must be provided to the IRB.  A 
copy of these reports must be forwarded to the sponsor.  The Investigator must maintain an accurate and 
complete record of all submissions made to the IRB, including a list of all reports and documents 
submitted.  Adverse experiences which are reported to the FDA and/or to other regulatory agencies, as 
Expedited Safety Reports, must be submitted promptly to the IRB. 
At least once per year, the IRB must review and give written approval to continue the study.  A copy of 
this written approval, referring to the study by protocol title and number, as given by the Sponsor, must 
be provided to the Sponsor. 
This trial will be conducted in accordance with FDA regulations and ICH-GCP.  
17.2. Protocol Amendments 
The Investigator will not modify the protocol without first obtaining concurrence in writing from the 
Sponsor.  If an amendment is required, this must be made in written form and receive approval according 
to the appropriate SOP.  All changes to the protocol must be submitted to the IRB.  Protocol 
modifications that impact subject safety or the validity of the study must be approved by the IRB and 
submitted to the FDA before initiation. 
17.3. Retention of Records 

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FDA and ICH-GCP guidelines require that an Investigator retain subject identification codes, subject files, 
and source data for the maximum period of time permitted by the hospital, institution, or private practice, 
but not less than 2 years.    
17.4. Finance, Insurance, and Publication 
Insurance coverage will be handled according to local requirements. 
Finance, insurance, and publication rights are addressed in separate agreements as appropriate. 

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 REFERENCES 
Adamson, P. B., Magalski, A., Branschweig, F., Bohm, M., Reynolds, D., Steinhaus, D., et al. (2003). 
Ongoing right ventricular hemodynamics in heart failure: clinical value of measurements derived from an 
implantable monitoring system. Journal of the American College of Cardiology , 41, 565-71. 
Abraham, W. T., Adamson, P. B., Bourge, R. C., Aaron, M. F., Costanzo, M. R., Stevenson, L. W., 
Yadav, J. (2011). Wireless pulmonary artery haemodynamic monnitoring in chronic heart failure: a 
randomised controlled trial. Lancet, 377, 658-66. 
Bourge, R. C., Abraham, W. T., Adamson, P. B., Aaron, M. F., Aranda, J. M., Magalski, A., . . . Group, 
C.-H. S. (2008). Randomized Controlled Trial of an Implantable Continuous Hemodynamic Monitor in 
Patients with Advanced Heart Failure: The COMPASS-HF Study. Journal of the American College of 
Cardiology, 51, 1073-79. 
Cui L, Hung HMJ, Wang, SJ.  Modification of Sample Size in Group Sequential Clinical Trials. Biometrics 
1999;55:853-857. 
Go AS, Mozaffarian D, Roger VL, et al. Heart disease and stroke statistics–2013 update: a report from 
the American Heart Association. Circulation 2013;127:e6–245. 
HFSA, Lindenfeld, J., Albert, N. M., Boehmer, J. P., Collins, S. P., Ezekowitz, J. A., et al. (2010). 
Executive Summary: HFSA 2010 Comprehensive Heart Failure Practice Guidelines. Journal of Cardiac 
Failure , 16, 475e-539e. 
Setoguchi, S. N. (2009). Maximum potential benefit of implantable defibrillators in preventing sudden 
cardiac death after hospital admission because of heart failure. Canadian Medical Association Journal , 
180 (6), 611-16. 
Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA Guideline for the Management of Heart Failure: 
A Report of the American College of Cardiology Foundation/American Heart Association Task Force on 
Practice Guidelines. J Am Coll Cardiol. 2013;62(16):e147-e239. doi:10.1016/j.jacc.2013.05.019. 
  
 
 

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APPENDICES 
APPENDIX A: Anticipated Study Timeline 
 

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APPENDIX B: Schedule of Events 
 
Screening 
Baseline 
(Implant) 
Month 1 
Months 6 and every 6 Months 
thereafter until Study Termination 
Procedures 
 
 (within 30 days 
of Screening) 
Visit 1 
(30 ± 7 days) 
Visits 2-5 or Study Termination 
(± 30 day window) 
Informed Consent 
X 
 
 
 
Demographics 
X 
 
 
 
Past Medical & Surgical History 
X 
 
 
 
Inclusion/Exclusion Criteria Review 
X 
X 
 
 
GFR 
X 
 
 
 
Kansas City Cardiomyopathy Questionnaire 
(KCCQ-12) 
X 
 
 
X 
Brief Illness Perception Questionnaire 
X 
 
 
X 
Cardiac Health Security Survey 
X 
 
 
X 
INR (if indicated) 
 
X 
 
 
Pulmonary artery measurement 
 
X 
 
 
Physical Examination (including weight) 
X1 
X2 
X2 
X2 
NYHA HF Classification 
X 
 
X 
X 
Pulmonary Artery Angiography 
 
X 
 
 
Sensor Implant 
 
X 
 
 
Sensor Measurements  
 
X 
X 
(Investigator 
discretion) 
X 
(Investigator discretion) 
Adverse Events Assessment 
 
X 
X 
X 
Medication Assessment (heart failure) 
X 
X 
X 
X 
1 Includes weight, height and vital signs (temperature, blood pressure, pulse, respirations).  
2 Includes weight, vital signs and significant changes from previous physical examination 
 

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APPENDIX C:  NYHA Functional Classification for Heart Failure 
The New York Heart Association (NYHA) Functional Classification provides a simple way of 
classifying heart disease (originally cardiac failure), useful for pre-operative and post-operative 
assessment.  It places subjects in one of four categories, based on how much they are limited 
during physical activity: 
Class I (Mild): Subjects with no limitation of activities; they suffer no symptoms.  
Class II (Mild): Subjects with slight, mild limitation of activities and suffer mild symptoms (slight 
swelling of extremities).  
Class III (Moderate): Subjects with marked limitation of activity; they are comfortable only at 
rest.  
Class IV (Severe): Subjects who are unable to do any physical activity without discomfort; they 
suffer with HF symptoms at rest and are confined to bed or chair.  
 

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APPENDIX D:  Management of Hemodynamic Parameters 
The CardioMEMS HF System allows intermittent assessment of pulmonary artery systolic, 
diastolic and mean pulmonary artery pressures.  Hemodynamic information obtained by the 
system should be used for clinical decision making in addition to symptoms, weights or physical 
examination (traditional markers of volume). 
Pulmonary Artery Pressure 
Ranges: 
PA Systolic  
15 - 35 mmHg 
PA Diastolic  
8 - 20 mmHg 
PA Mean  
10 - 25 mmHg 
 
Initially, thresholds will be set automatically at the acceptable range.  The physician can adjust 
the thresholds specifically for each patient.  These threshold notifications are intended to guide 
the physician to review the CardioMEMS HF Website.  Every attempt should be made to keep 
the pulmonary artery pressures within the specified pulmonary artery pressure ranges utilizing 
the guidelines.  In order to clinically manage patient’s PA pressures, the physician must review 
the PA pressure measurements on a frequent basis, for example, some patients may require a 
daily review of their PA pressure measurements, while some patients may need a weekly 
review.  The physician or designee has unlimited access to the CardioMEMS HF Website.   
An elevation of pressures beyond the patient’s pressure ranges should be considered a volume 
overloaded status and should be managed according to the hyper-volemic guidelines (see 
below). Diuretics and vasodilators should be adjusted based on the patient’s baseline diuretic 
requirement, knowledge of the patient’s prior response to these agents, and clinician judgment 
to accomplish the pressure goals set forth in this guideline.   
A decrease in the pulmonary pressures below the patient’s pressure ranges should be 
considered a volume depletion event and managed according to the hypo-volemia guidelines 
(see below) (see below).  Diuretic therapy should be held and the chronic dose should be 
lowered. 
In addition to these specific guidelines, the physician should also incorporate the 
recommendations set forth in the ACC/AHA 2013 Guidelines for the Diagnosis and 
Management of Heart Failure in the Adult.  
The PA pressure readings should be used in addition to weights, signs and symptoms, 
laboratory values and other traditional markers of volume in the management of heart failure. It 
is important to review the trend of PA pressures. As with all other diagnostic information, 
physicians should consider the entire medical history of each patient when initiating or modifying 
therapies. 
 

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Elevated PA Pressures (Hyper-volemic) 
Hyper-volemic Definitions 
• 
Subject symptoms:  Congestive symptoms (wet) 
• 
CardioMEMS HF System Parameters:  above  the acceptable range 
• 
Daily trends:  elevated trend data outside the acceptable range 
• 
Weekly trends:  elevation in trend data 
Treatment Recommendations 
• 
Add or increase diuretic (and appropriate electrolyte replacement) 
a. Increase or add loop diuretic 
b. Change to another loop diuretic 
c. Add thiazide diuretic (with caution) 
d. IV doses of loop diuretic  
e. Serum electrolyte evaluation with change in baseline medication 
f. Re-assess pulmonary artery pressure utilizing the CardioMEMS HF System at least 
2 – 3 days per week until optivolemic 
• 
Add or increase vasodilators including long-acting nitrates  
• 
Re-educate in salt intake and fluid restriction 
• 
If subject has signs and symptoms of poor perfusion (cold) in addition to being hyper-
volemic: 
a. Consider admission if clinical evidence suggests need for IV diuretics, telemetry 
monitoring or the IV therapeutic agents 
b. Consider invasive hemodynamic monitoring for determination of Cardiac Output, if 
indicated 
 
 

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Low PA Pressures (Hypo-volemic) 
Hypo-volemic Definitions 
• 
Subject symptoms:  poor perfusion in absence of signs and symptoms of congestion 
• 
CardioMEMS HF System Parameters:  below the acceptable range 
• 
Daily trends:  decrease in trend data outside the acceptable range 
• 
Weekly trends:  decrease in trend data 
Treatment Recommendations 
• 
Lower or discontinue diuretic 
a. If on a thiazide diuretic with loop diuretic, lower or discontinue the dose of 
thiazide (and adjust electrolyte replacement) 
b. If on only loop diuretic, lower the dose or discontinue  
c. Consider liberalization of oral fluid restriction and salt restriction 
• 
If postural hypotension, hold or lower vasodilators and/or oral nitrates, especially if 
hypotensive when sitting or supine 
• 
If worsening renal function, hold or lower ACE/ARB dose, especially if hypotensive 
• 
If subject had signs and symptoms of poor perfusion (cold) in addition to being hypo-
volemic: 
a. Consider admission if clinical evidence suggests need for IV fluid repletion, telemetry 
monitoring or the use of IV therapeutic agents 
b. Consider invasive hemodynamic monitoring for determination of Cardiac Output, if 
indicated  
 
 

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Recommended Frequency of CardioMEMS HF System Review 
Subject Status 
Weekly 
At least  2– 3 times 
per week until 
optivolemic 
At least 2 – 3 times 
per week until 
pressure stabilizes 
Acceptable PA 
Pressure 
(Opti-volemic) 
X 
 
 
Elevated PA Pressure 
(Hyper-volemic) 
 
X 
 
Low PA Pressure 
(Hypo-volemic) 
 
X 
 
Medication 
modifications 
 
 
X 
Significant deviations in 
trend data 
 
 
X 
 
 
 
 
 

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APPENDIX E:  Kansas City Cardiomyopathy Questionnaire-12 
 

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APPENDIX F:  Brief Illness Perception Questionnaire (English) 
 
 
 

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APPENDIX G: Cardiac Health Security Survey 
 

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APPENDIX H:  BMI Calculator 
 
To calculate subjects Body Mass Index using the website below:  
 
http://www.nhlbisupport.com/bmi/bmi-m.htm  
 
Enter the subjects Weight and Height and then calculate BMI (print screen for source 
documentation) 
 
Formulas used to calculate Body Mass Index: 
 
English BMI Formula 
BMI = Weight in pounds/ (height in inches x height in inches) x 703 
 
Metric BMI Formula 
BMI = Weight in kilograms/ (height in meters x height in meters)  
 
Note that BMI may also be calculated within the eCRF. 

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APPENDIX I:  Glomerular Filtration Rate 
 
To calculate subjects Glomerular Filtration Rate use the website below: 
 
http://www.nephron.com/cgi-bin/CGSI.cgi 
 
Enter the subjects Creatinine level, Age, Race, Gender then calculate (print screen for source 
documentation) 
 
GFR (mL/min/1.73 m2) =  186 x(Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African 
American) 
 
 
Note that GFR may also be calculated within the eCRF. 
 
 
 

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APPENDIX J:  Protocol Definitions 
Enrollment – After meeting study inclusion criteria and following successful Sensor implant, 
subjects are considered enrolled 
Hospitalization – Greater than or equal to 24 hours in a hospital  
HF Hospitalization – hospitalization determined to be related to heart failure as determined by 
the CEC 
Active Infection- Febrile, elevated WBC, left shift, on antibiotics, positive cultures (blood, 
sputum or urine) 
PI – Appropriate clinician designated as the Principal Investigator on the “Investigator 
Agreement” received and approved by St. Jude Medical.  For study related procedures/visits PI 
refers to the PI or his/her designee. 
Source documents – Primary study documentation including electronic, paper, phone 
messages, etc. containing study-pertinent information such as visit information, clinical history, 
medications, (S)AE reporting, etc. These documents are originals and should be treated as 
such. Information from these documents will be transferred from and compared against 
information reported in study CRFs 
Sub-investigator – Clinical personnel designated as a sub-investigator on the “Investigator 
Agreement” received and approved by St. Jude Medical 
Worksheets –Source documents used for calculation of clinical values such as BMI or EGFR 
from screening to end of study.  Worksheets may also be used during the sensor implant or 
follow-up visits to capture information not captured in the medical record.  In order for these 
worksheets to be considered valid, the Investigator must sign and date the worksheet.   
 
 
 
 

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APPENDIX K:  Composition, Function, and Procedures of the Clinical 
Events Committee (CEC) 
 
The hospitalizations and deaths in this study will be monitored by a Clinical Events Committee 
(CEC).  The committee will be comprised of physicians, who will not participate in the enrollment 
or treatment of subjects in this trial.  The CEC members have agreed with the study design and 
protocol.  CEC members are independent and cannot be removed based on difference of 
opinion on study-related matters with St. Jude Medical, Investigators, or any St. Jude Medical 
contractor. 
The members of the CEC are responsible for reviewing the safety data and providing an 
assessment of the data according to their individual expertise.  The CEC Committee will 
evaluate all SAEs to determine whether or not the SAE is device / system-related.  The 
interpretation of events as classified and adjudicated by the clinical events committee will be 
used in the final effectiveness and safety analyses. 
The role and procedures of the CEC Committee will be detailed in the CEC charter. 
 
 

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APPENDIX L:  Reporting of Interim Analyses 
Updates from the PAS will be submitted to FDA as a PMA supplement every 6 months for the 
first two years of the study (annually thereafter). This information will include the following 
information: 
 
Study enrollment and follow-up status 
 
 
 

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Demographic information 
 
Premarket 
Study 
PAS 
Aggregate 
PAS Male 
PAS Female 
Average Age (years) 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
Male 
XX.X% 
XX.X% 
XX.X% 
XX.X% 
Caucasian 
XX.X% 
XX.X% 
XX.X% 
XX.X% 
Average BMI 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
Average LVEF 
XX.X ± XX.X% 
XX.X ± XX.X% 
XX.X ± XX.X% 
XX.X ± XX.X% 
LVEF < 40% 
XX.X% 
XX.X% 
XX.X% 
XX.X% 
Ischemic Cardiomyopathy 
XX.X% 
XX.X% 
XX.X% 
XX.X% 
Average PA Systolic (mmHg) 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
Average PA Diastolic (mmHg) 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
Average PA Mean (mmHg) 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
Average PA Wedge (mmHg) 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
Average Cardiac Output 
(L/min) 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
Average Cardiac Index 
(L/min/m2) 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
 
Safety 
 
6 Months 
N=XXXX 
12 Months 
N=XXXX 
18 Months 
N=XXXX 
24 Months 
N=XXXX 
 
N 
Percent 
N 
Percent 
N 
Percent 
N 
Percent 
DSRCs 
XXX 
XX.X% 
XXX 
XX.X% 
XXX 
XX.X% 
XXX 
XX.X% 
Pressure Sensor Failures 
XXX 
XX.X% 
XXX 
XX.X% 
XXX 
XX.X% 
XXX 
XX.X% 
 
Heart Failure Hospitalizations 
 
6 Months 
N=XXXX 
12 Months 
N=XXXX 
18 Months 
N=XXXX 
24 Months 
N=XXXX 
HF Hospitalizations 
XXX 
XXX 
XXX 
XXX 
HF Hospitalization Rate:         
Events/patient years 
Events/patient days 
 
X.XX 
X.XX 
 
X.XX 
X.XX 
 
X.XX 
X.XX 
 
X.XX 
X.XX 
HF Hospitalization Proportion 
XX.X% 
XX.X% 
XX.X% 
XX.X% 
 
Mortality 
 
6 Months 
N=XXXX 
12 Months 
N=XXXX 
18 Months 
N=XXXX 
24 Months 
N=XXXX 
 
Deaths 
Percent 
Deaths 
Percent 
Deaths 
Percent 
Deaths 
Percent 
All Cause Deaths 
XXX 
XX.X% 
XXX 
XX.X% 
XXX 
XX.X% 
XXX 
XX.X% 
Cardiac Deaths 
XXX 
XX.X% 
XXX 
XX.X% 
XXX 
XX.X% 
XXX 
XX.X% 
Non-Cardiac Deaths 
XXX 
XX.X% 
XXX 
XX.X% 
XXX 
XX.X% 
XXX 
XX.X% 
 
 
 

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Serious Adverse Events 
 
6 Months 
N=XXXX 
12 Months 
N=XXXX 
18 Months 
N=XXXX 
24 Months 
N=XXXX 
 
Subjects 
Events 
Subjects 
Events 
Subjects 
Events 
Subjects 
Events 
All Patients 
with  
an Event 
XX 
(XX.X%) 
XXX 
XX 
(XX.X%) 
XXX 
XX 
(XX.X%) 
XXX 
XX 
(XX.X%) 
XXX 
System Organ 
Class I 
XXX 
XXX 
XXX 
XXX 
XXX 
XXX 
XXX 
XXX 
… 
 
 
 
 
 
 
 
 
 
Days alive outside of hospital for heart failure 
 
6 Months 
N=XXXX 
12 Months 
N=XXXX 
18 Months 
N=XXXX 
24 Months 
N=XXXX 
 
N 
N 
N 
N 
Days Alive outside of Hospital 
XXX 
XXX 
XXX 
XXX 
 
Weekly Patient Pressure Reading Compliance 
 
Compliance % 
Mean ± StdDev 
XX.X ± XX.X% 
Median 
XX.X% 
 
Sensor Performance 
 
N 
Percent 
Number of Patients 
XXX 
XX.X% 
Number of RHCs with comparative readings 
XXX 
XX.X% 
 
Results will presented using Bland-Altman comparing Sensor vs. Swan-Ganz.   
 
 
 
 

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Medication changes in response to PA pressure 
 
# Medications 
Medication Changes in Response to PA 
Pressure 
N 
Percent 
ACE/ARB 
XXX 
XX.X% 
Aldosterone Antagonist 
XXX 
XX.X% 
Beta-blocker 
XXX 
XX.X% 
Diuretic-Loop 
XXX 
XX.X% 
Diuretic-Thiazide 
XXX 
XX.X% 
Hydralazine 
XXX 
XX.X% 
Nitrate 
XXX 
XX.X% 
Other 
XXX 
XX.X% 
Total 
XXX 
XX.X% 
 
 
 

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Appendix M:  Schematic Diagram of Main PAS Study and Substudy 
 
 

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Appendix N:  informed consent template 
 
CONSENT TO PARTICIPATE IN A CLINICAL STUDY 
 
Title: 
CardioMEMSTM HF System Post Approval Study 
 
Sponsor:   
 
 
St. Jude Medical, Inc. 
 
 
 
 
 
Institution:    
 
(Name)  
 
 
       
 
(Address) 
 
 
 
 
(City, State zip) 
 
Principal Investigator:   
(Name, title) 
 
 
 
 
(Address) 
 
 
 
 
(City, State zip) 
 
 
 
 
(Phone) 
 
 
 
INTRODUCTION 
 
You have been diagnosed with heart failure.  Heart failure (HF) is a disorder resulting from 
damage to the heart. Hypertension (high blood pressure) or coronary artery disease (narrowed 
or blocked blood vessels to the heart) are the most common causes of heart failure.   This 
damage makes it difficult for the heart to pump enough blood to meet the demands of the body.  
Heart failure is a progressive disease that often gets worse over time.   
Physicians treating heart failure patients rely on signs and symptoms, physical exams, and lab 
values to manage your therapy.  In addition, special procedures are needed to evaluate the 
condition and performance of the heart.  One of these procedures is a right heart 
catheterization.  During this procedure, pressures in the heart and the blood vessels close to the 
heart are measured using a pulmonary artery catheter (a thin, flexible tube).  A heart 
catheterization offers valuable information to the physician; however, it is limited to a one-time 

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“snap-shot” of the pulmonary artery pressures related to heart function.  CardioMEMS 
developed a technology that provides physicians with reliable, accurate daily trends of 
pulmonary artery pressure measurements.  This technology proved to be extremely valuable in 
the management of care for heart failure patients.  
The CardioMEMS HF System provides a method to measure pulmonary artery (PA) pressures 
by using a small wireless sensor (about the size of a paperclip) implanted into the pulmonary 
artery (a vessel close to your heart).  Once implanted, the sensor communicates through radio 
frequency to an antenna contained in a pillow connected to an electronic unit and then transmits 
this valuable information to a secure website for your doctor to review.  You will be able to take 
these PA pressure measurements yourself at home.  In addition to these home readings, your 
PA pressures can also be obtained in the physician’s office, clinic, or hospital.    Your doctor can 
access the secure website to view your measurements allowing him/her to make earlier 
treatment changes (usually changes in medications) to manage your heart failure remotely.   
The CardioMEMS HF System was evaluated during a recent clinical study.   The CHAMPION 
trial was conducted at 64 study sites in the U.S. and enrolled 550 patients with NYHA Class III 
heart failure who had been hospitalized for heart failure in the previous year.  All patients were 
implanted with a sensor and then assigned by chance to either the Treatment group (heart 
failure management on the basis of pulmonary artery pressure and standard of care) or the 
Control group (heart failure management on the basis of standard of care). CHAMPION met its 
primary endpoint of reduction in the rate of heart failure hospitalizations with Treatment patients 
having 28% fewer heart failure hospitalizations compared to Control patients at 6 months; the 
benefit was sustained with a 37% reduction over the entire study time period which averaged 15 
months.  Treatment patients also experienced an improvement in their quality of life compared 
to Control patients.  
The FDA approved the CardioMEMS HF System for commercial use in the USA in May of 2014.  
Part of the FDA’s responsibility to the public is to make sure that medical devices are safe and 
work correctly after they are approved.  As such, the FDA has requested the sponsor of the 
device, St. Jude Medical, to conduct a Post Approval Study (PAS).  This study can give 
patients, doctors, the sponsor, and the FDA valuable information on the safety, effectiveness 
and reliability of the CardioMEMS HF System.   
You are being invited to participate in the CardioMEMS HF System Post Approval Study.  This 
consent form will inform you of the risks and benefits of participating in this study.  Before you 
agree to volunteer, you should know as much as possible so that you can make an informed 
decision about taking part in this Post Approval Study.  It is important that you read the following 
information and ask as many questions as necessary.   
This is a commercial device and participation in the PAS does not increase your health risks or 
require additional steps.  A right heart catheterization is required to implant the sensor and the 
PA pressure-based medical management provided by your doctor will be the same, regardless 
of study participation.   
 

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PURPOSE  
The objective of this Post Approval Study is to demonstrate that data collected related to the 
use of the CardioMEMS HF System in a commercial setting are comparable with data collected 
in a controlled clinical trial. 
This is a prospective, open-label clinical trial to be conducted at up to 150 clinical sites in the 
United States (US).  There will be 1200 patients enrolled in the study.  
CardioMEMS HF SYSTEM 
The CardioMEMS HF System consists of a sensor, delivery system, external electronics 
(hospital and patient units) and the patient website.  The System will be used in your home to 
transmit your pulmonary artery pressure measurements to a secure website for your physician 
to review and determine the best way to manage your heart failure.  Your physician may also 
use the System in the clinic or in the hospital.   
QUALIFICATIONS 
 
You have been asked to consider participation in this study because: 
• 
You are willing to review and sign an informed consent 
• 
You are at least 18 years old 
• 
You have been diagnosed with heart failure and have been classified as NYHA Class III 
• 
You have experienced at least 1 hospitalization within the past 12 months because of 
your heart failure 
• 
Your Body Mass Index (a calculation using your weight and height) is acceptable for the 
study 
• 
You are willing to comply with the requirements of the study, including taking PA 
pressure readings from home as directed by your doctor  
STUDY VISITS  
Screening Visit  
In order to participate in this study the following tests, examinations and reviews will need to be 
completed and the results must meet the study requirements: 
• 
Physical examination including vital signs (temperature, heart rate, respiratory rate, 
blood pressure), weight, height, Body Mass Index calculation 
• 
Medical and surgical history 
• 
Demographics information (age, race, date of birth) 
• 
New York Heart Association Classification for heart failure (a classification your doctor 
uses to describe your heart failure) 
• 
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) 

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• 
Brief Illness Perception Questionnaire 
• 
Cardiac Health Security Survey  
• 
Laboratory tests (if necessary)  
• 
Heart failure medication review 
Your doctor will determine if you can participate in the study after your examination and lab tests 
have been reviewed.  Once your study eligibility is confirmed, your physician’s office will 
schedule the Sensor implant visit.  You may be instructed to stop taking blood thinning 
medications 1-2 days before the implant procedure. 
Implant Procedure (Baseline)  
During the sensor implant visit, the following procedures will be performed: 
• 
Physical examination including vital signs (temperature, heart rate, respiratory rate, 
blood pressure) and weight 
• 
New York Heart Association Classification for heart failure  
• 
Lab tests:  Prothrombin Time (PT) with International Normalized Ratio (INR) if you have 
been prescribed warfarin  
• 
Heart failure medication review 
• 
Right heart catheterization and sensor implant procedure  
• 
Review of adverse events that occurred (if any) since the baseline visit 
 
The Sensor will be implanted during the heart catheterization procedure. The Sensor is about 
the size of small paper clip and has a thin curved wire at each end.  It is placed inside your 
pulmonary artery (one of the vessels close to the heart) with a special delivery catheter.   
 
Figure 1. CardioMEMS HF Sensor  
 
You may receive a mild sedative before and/or during the procedure but you will be awake so 
you can follow instructions.  An area on your groin will be cleansed with sterile soap and a local 
anesthetic (numbing) medicine will be injected at that site.  
There are two parts to the procedure, the right heart catheterization (RHC) and the Sensor 
implant.  The heart catheterization is performed first.  A pulmonary artery catheter is inserted in 
your groin and then carefully threaded into your heart using an x-ray machine to produce 
pictures (fluoroscopy).  Your heart rate and rhythm will be constantly monitored by an 
electrocardiogram (ECG).  Once the catheter is in the pulmonary artery, a small amount of 
contrast material (dye) is injected and pictures are taken to make sure the catheter is in the right 
position and to make sure the branch of the pulmonary artery is the appropriate size.  This 
procedure is called angiography.  

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Next, a delivery catheter with the Sensor attached is carefully threaded to your pulmonary artery 
over a guide wire (a very small wire used to guide catheters).  The Sensor is then positioned in 
the pulmonary artery and released from the delivery catheter.  The delivery catheter will be 
removed and the pulmonary artery catheter positioned next to the Sensor.  Once the Sensor is 
confirmed by x-ray to be in the correct position, it will stay inside the pulmonary artery 
permanently.  The doctor will hold a monitor (called an antenna) to your back, chest or side to 
obtain the Sensor’s signal.  Pulmonary artery pressure readings will be recorded from both the 
Sensor and the pulmonary artery catheter.  The heart catheter is removed and the Sensor will 
remain in your pulmonary artery 
If the doctor is unable to safely pass the catheter into the pulmonary artery or if the pulmonary 
artery branch is not the appropriate size, you will not be able to receive the Sensor.  Your doctor 
will follow your progress for 30 days and then afterward you will no longer participate in the 
study.  
The procedure (RHC and Sensor implant) may last up to one hour.  After the procedure is 
completed, you may be asked to lay flat on your back for a few hours, to prevent any bleeding 
from the catheter insertion site.  At your doctor’s discretion, you may be discharged the day of 
the procedure or you may be required to stay in the hospital overnight so that your condition 
may be observed and evaluated. 
Following the implant procedure, your doctor will give you instructions on taking a blood thinning 
medication.  If you are currently on warfarin therapy, you will be asked by your doctor to restart 
this medication.  If you are not currently on warfarin therapy, you will be placed on clopidogrel 
(75 mg) daily for 1 month and aspirin (81 mg or 325 mg) daily.  If necessary, laboratory tests on 
your blood will be done periodically so your doctor can make certain you are receiving the 
proper blood thinning medication during the trial. 
After the procedure, your doctor or nurse will instruct you how to set-up and take PA pressure 
readings from your home using the patient electronics system (home readings typically take less 
than one minute to complete).  It is important that you are comfortable with setting up your 
patient electronics system and that you understand how to take a reading.  Should you need 
assistance with the System when you get home, you may call the St. Jude Medical helpline at 
877-696-3754.   
Your physician will have access to your hemodynamic information (PA pressure readings and 
heart rate) through the CardioMEMS HF System.  He/she will evaluate your pulmonary artery 
pressures daily or weekly as required and use the information to better manage your heart 
failure. Therefore, it is very important that you take pressure readings as directed by your 
doctor.  
You will be contacted by your doctor or his/her staff periodically during the study when 
adjustments in your medications are necessary.  You should feel free to contact your physician 
or his/her staff as you would normally.  It is important that you notify your study doctor 
immediately if you have any worsening symptoms of heart failure. 
As a participant in the Post Approval Study, it is very important that you follow all the 
instructions from your doctor, including taking PA pressure readings and going to all of the 
scheduled follow-up visits.   
Follow-Up Visits 

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You will return to see your doctor for follow up study visits at 1 month following your implant 
procedure and 4 more times over the next 2 years (6 months, 12 months, 18 months, and 24 
months).  During the study visits, the following procedures will be performed:  
• 
Updated medical and surgical history 
• 
Assessment of adverse events if any occurred since your last visit 
• 
Physical examination including vital signs (temperature, heart rate, respiratory rate, 
blood pressure), and weight  
• 
Assessment of your NYHA functional class 
• 
Kansas City Cardiomyopathy Questionnaire 
• 
Brief Illness Perception Questionnaire 
• 
Cardiac Health Security Survey  
• 
Review of your heart failure medications  
• 
Your doctor may obtain PA pressure measurements during the visit 
• 
You will be reminded to take your PA pressure readings and will be provided counseling 
regarding the AHA guidelines for sodium and fluid restrictions in your diet.  
STUDY DURATION 
Your involvement in this Post Approval Study will last for two (2) years.   
RIGHT TO WITHDRAW 
Participation in this study is voluntary.  You have the right to withdraw your consent and stop 
taking part in this study at any time without penalty and your doctor will continue to treat you 
regardless of your participation.  However, we encourage you to talk to the research 
coordinator, nurse and your doctor about your decision before you withdraw.   
Your participation may also be ended without your consent if your study doctor feels that it is in 
your best interest.  The study Sponsor or the Ethics Committee may discontinue the study at 
any time for safety, administrative or other reasons.  
RISKS  
To date, the CardioMEMS HF System has been safely tested in 567 patients in the United 
States.  During the CHAMPION trial, there were no failures of the device (sensor) and no other 
unanticipated complications.  We do not know all of the risks.  Some of the possible risks are 
also complications of the right heart catheterization and/or drugs associated with the procedure 
and blood thinning medications.  Some of these risks include: 
 
• 
Air embolism (air bubble in the bloodstream)  
• 
Allergic reaction 
• 
Abnormal heart rate or rhythm 

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• 
Bleeding  
• 
Bruising 
• 
Chest pain 
• 
Myocardial infarction  
• 
Nausea 
• 
Stroke 
• 
Infection 
• 
Delayed wound healing 
• 
Thrombus formation (blood clots) 
• 
Hematoma (collection of blood internally) 
• 
Venous trauma (injury to your veins) 
• 
Valve damage  
• 
Sensor not releasing from delivery system 
• 
Pulmonary infarct (damage to the lung) 
• 
Pulmonary embolism (blood clot to the lung) 
• 
Death 
Some of the side effects that you may experience will go away shortly after the procedure, but in 
other cases side effects can be serious, long lasting, and/or permanent.   
Resetting of the sensor baseline may also be performed as deemed necessary by Sponsor or 
your physician.  Baseline resetting may require an echocardiogram or a RHC procedure and 
would include the risks associated with those procedures.   
BENEFITS  
The results of the CHAMPION trial showed that through the use of the information obtained 
from the CardioMEMS HF System, physicians were able to adjust medications that allowed for a 
significant reduction in hospitalizations for heart failure.  To experience the most benefit from the 
CardioMEMS HF System, it is important that you take readings daily or as instructed by you 
physician.  Your participation in the Post Approval Study will also help your doctor, the sponsor, 
and the FDA evaluate the public health benefit for patients in the future.   
ALTERNATIVE THERAPIES 
An alternative is not to participate in this study and continue with your current care. If you 
choose not to be in the study and the CardioMEMS sensor is implanted, your doctor will still 
have access to the PA pressure data provided from the CardioMEMS HF System and use that 
information in addition to traditional standard of care methods to follow and treat your heart 
failure.   
There are no other FDA approved therapies similar to the CardioMEMS HF System. Currently, 
patients’ weights are monitored by simple or sophisticated scales and medications are adjusted 

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accordingly. There are also telephone or internet systems used for the monitoring of worsening 
heart failure symptoms.   
NEW INFORMATION  
If significant new information that may affect your participation in the study is discovered, your 
doctor will be given the information as soon as possible for review and discussion with you.   
COSTS 
The CardioMEMS HF System is an approved medical device covered by Medicare and most 
insurance providers. There are no additional costs to you for your participation in this study. The 
costs of the visits required for the study will be paid for by the sponsor. 
INJURY  
If you suffer an injury resulting directly from the study, the reasonable costs of medical treatment 
will be paid for you, to the extent such costs are not covered by your medical or hospital 
insurance or third-party or governmental programs providing such coverage. 
ROLE OF THE SPONSOR’S REPRESENTATIVE 
The role of the Sponsor (St. Jude Medical) representative in this study is to provide training and 
technical support.  A representative of the sponsor may be present during the implant 
procedure.  The sponsor’s representative may assist your doctor to make sure your 
CardioMEMS HF System is working as expected.  The representative will work under the 
direction of your doctor and may be aware of your medical history but will in no way compromise 
your confidentiality.   
CONFIDENTIALITY AND PROTECTED INFORMATION 
By signing this form, you allow access to your medical records to the study doctors and their 
staff, the Sponsor or its representative(s), representatives of the Institutional Review Board 
(IRB) and representatives from the regulatory agencies.  If you decide to take part in this 
research study, your medical records and personal information will be kept confidential to the 
extent allowed by Federal, State, and local law.  However, information from the study may be 
exported to countries where different data protection laws apply.  The data protection laws in 
other countries may be less strict than those of your country.  
The results of this study may be reported or published.  However, you will never be identified by 
name nor will other personal identifying information about you be released in a publication.  A 
description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This website will not include information that can identify you. At most, the website 
will include a summary of the results. You can search this website at any time. 
Medical records and information regarding your health status are protected information.  
Because this information is protected, (Institution Name) is required by law to let you know 
what types of information about you may be requested and how your information will be used 
and disclosed for this study.  The next few paragraphs give you additional information about 
how your medical records and health information will be used, disclosed, and stored.  By signing 
this form, you also authorize and request all other health care providers who examine and/or 
treat you during your participation in this study and any necessary follow-up to this study, to 
release all relevant and necessary medical records to (Institution or Principal Investigator) at 

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its request.  If all information that does or can identify you is removed from your health 
information, the remaining information will no longer be subject to this authorization and may be 
used and disclosed for other purposes. 
Information from this study will be submitted to the study Sponsor and the US Food and Drug 
Administration (FDA).  It may also be submitted to governmental agencies in other countries 
where the device may be considered for approval.  In order to verify information collected in this 
study and to verify how the study was conducted, your medical records related to the study, the 
consent form signed by you, and any other regulatory documents associated with the study, will 
be inspected and may be copied by: 
• 
The study doctor and study staff 
• 
The Sponsor and/or their representative 
• 
The IRB/IEC (ethics committee) 
• 
The FDA 
The Sponsor may store, access, use and disclose the information in any of the following ways:  
• 
To analyze and make conclusions about the results of the study, 
• 
In documents sent to the government agencies throughout the world including the U.S. 
Food and Drug Administration (FDA (or other similar bodies outside the United States) to 
request reviews/approvals relating to the System, 
• 
For reporting undesirable events to the FDA (choose agency) and other government 
health agencies, 
• 
To provide overall study results to other study doctors, including in publications, 
• 
To conduct new medical research study, to reanalyze the study results in the future or to 
combine your information with information from other studies, 
• 
To develop new medical products and procedures, and other product-development 
related activities. 
• 
To remove identifying information (such as name, address, etc.) from the information 
and then use and disclose the resulting information for other purposes. 
While using the information in these ways, the sponsor may give study data to its affiliated 
companies in the U.S. or other countries. The sponsor may also share the information with its 
business partners or companies it hires to provide study-related services. 
Your authorization for the access, use and/or disclosure of your health information for the 
purposes described in this document does not expire. If you decide to participate in the research 
study, you are free to withdraw your authorization regarding the access, use and disclosure of 
your health information at any time. If you wish to revoke your authorization, you must write to 
____________ [insert appropriate address]. If you drop out of this study, the study sponsor and 
study doctor will continue to use and disclose any information about you [or from you] that 
were gathered before you dropped out in order to preserve the integrity of the research study.  

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You have the right to request copies of the medical tests performed during the course of this 
study for as long as the study doctor has this information in his or her possession.  However, by 
signing this form you agree that you might not have full access to review study related medical 
test records until after the study is complete. 
CONTACT FOR QUESTIONS  
Please be sure to ask your doctor any questions or concerns you may have about being in this 
study.  Feel free to ask questions about the CardioMEMS HF System, the sensor, the implant 
procedure, risks, benefits, and alternative therapies available to you.  If you have questions 
regarding any part of the study, contact (Principal Investigator) at (phone number). 
This study was reviewed by the (Institutional Review Board), a special group of people that 
are independent of the study doctor and the Sponsor.  The purpose of this group is to protect 
the rights and safety of people who volunteer to take part in clinical studies such as this Post 
Approval Study.  If you have any questions about your rights as a study patient or a complaint or 
concern about participating in this study, you may contact (IRB Chairman) at (phone number). 
 
 
 
 

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CONSENT TO PARTICIPATE 
I choose to participate in the CardioMEMS HF System Post Approval Study.  I have read all of 
the above information or it has been read to me.  I have been given the opportunity to ask 
questions about this study and the required procedures.  My questions have been answered to 
my satisfaction.  After I sign the consent form, I understand I will receive a copy of it for my own 
records.  I am aware that I do not give up any of my legal rights by signing this consent form.    
 
Patient: 
 
 
 
 
Signature of Patient 
 
Date Signed 
 
 
Patient Name (print)  
 
Consent Obtained By: 
 
 
 
 
Signature 
 
Date Signed 
 
 
Name (print)  
 
 
Title 
 
Witness (if applicable): 
 
 
 
 
Signature 
 
Date Signed 
 
 
Name (print)