Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol
Phase: NA
Conditions: Advanced Refractory Left Ventricular Heart Failure
Sponsor: Abbott Medical Devices

 
Clinical Investigation Plan Cover Page 
 
 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
 
NCT Number: NCT02224755 
MOMENTUM 3 
Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate 3TM 
Study Document No: SJM-CIP-10206 
Version A 
Date: 08-May-2017 
 
 
Sponsor  
 
 
Abbott 
        
 
 
 
6035 Stoneridge Drive 
      
  
 
 
Pleasanton, CA 94588 
        
 
 
 
USA 
 
 
 

 
Thoratec® Corporation 
MOMENTUM 3 
IDE Clinical Study Protocol 
 
CONFIDENTIAL 
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Thoratec® Corporation  
 
MOMENTUM 3 
Multi-Center Study of MagLev Technology in Patients 
Undergoing MCS Therapy with  
HeartMate 3™ 
 
IDE Clinical Study Protocol 
 
IDE # G140113 
 
 
 
 
 
 
Sponsor: 
Thoratec Corporation 
6035 Stoneridge Drive 
Pleasanton, CA 94588 
Ph. (925) 847-8600 
Fax: (925) 847-8574 
 
 
 
Sponsor Contact: 
Lahn Fendelander, MS 
Director, Clinical Affairs 
Thoratec Corporation 
23 4th Avenue  
Burlington, MA 01803 
Ph. (781) 852-8310 
Mobile: (339) 927-8951 
 
 
 
Proprietary information: This document and the information contained herein may not be reproduced, 
used or disclosed without the permission of Thoratec Corporation. 

 
Thoratec® Corporation 
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REVISION HISTORY 
 
Version 
Date 
Revision Summary 
Originator 
Release Date 
1 
3/6/2014 
Original Protocol 
Kelly Maslin 
3/6/2014 
2 
4/22/2014 Update to Inclusion Criteria #6, update 
to functional status and independent 
assessor, clarification of pump log 
collection, modification to Modified 
Rankin Score timing, updated 
enrollment numbers, clarification of AE 
definitions; updated pager number; 
updated references 
Kelly Maslin 
4/24/2014 
3 
6/17/2014 Update to Exclusion Criteria #5, 
clarification to timeframe for 
randomization, clarification of x-ray 
collection, allow for collection of TEE 
post-implant, update number of study 
sites 
Kelly Maslin 
6/17/2014 
4 
8/1/2014 
Update to study design to reflect 10 
additional subjects allowable during 
FDA review; update to figure 2 to 
reflect 60 study sites; addition of 
independent assessor requirement for 
Modified Rankin Score; revised 
screening visit so that informed 
consent is signed after 
inclusion/exclusion assessment; 
subjects now considered enrolled at 
time of study consent; revised 
schedule of events such that 
INTERMACS profile is assessed 
immediately prior to implantation; 
updated reporting requirement to 
DSMB and FDA; updated treatment-
by-site interaction effect to be tested at 
0.15 level of significance 
Kelly Maslin 
8/4/14 

 
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Version 
Date 
Revision Summary 
Originator 
Release Date 
5 
4/1/2015 
Updated Sponsor contact information; 
clarification of exclusion criteria 12c , 
12e, and 14; clarification of time of 
enrollment in section 13.4; clarified all 
laboratory assessments to reflect only 
albumin or pre-albumin, and CRP or 
hs-CRP are required; clarification of 
pump log collection schedule in section 
16.8.1; addition of HeartMate 3 TM 
symbol. 
Kelly Maslin 
4/2/2015 
6 
8/4/2015 
Changed study name from HeartMate 
III IDE to MOMENTUM 3 IDE; changed 
HeartMate III to HeartMate 3; removed 
breakdown of number of subjects per 
arm; clarified use of MPU in section 3; 
clarified 50 patient enrollment cap in 
section 13.4; added 90 day window to 
assess eligibility in section 16.1 added 
visit window to post-op day 1 in section 
16.4; clarification of pump log 
submissionin all follow-up visits; added 
subject withdrawal and lost to follow-up 
language in section 22; updated Figure 
2 flow chart; added HeartLine 
emergency contact to section 32; 
updated Left atrial pressure to be 
collected if available inTable 2, 
corrected typographical errors in Table 
2. 
Kelly Maslin 
8/5/2015 
7 
3/3/2016 
Increased number of study sites from 
60 to 70; clarification to power source 
while in hospital in section 3; 
clarification to assessment timepoints 
in section 13.15 and 13.16.   
Kelly Maslin 
3/21/2016 

 
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Version 
Date 
Revision Summary 
Originator 
Release Date 
8 
5/8/2017 
Section 14.2: Changed required 
SAE reporting time from 24 hours 
to 3 days to align with Abbott 
clinical trial standard. 
Section 15: Changed required 
UADE reporting time from 24 
hours to 3 days to align with 
Abbott clinical trial standard. 
Footer: added Sponsor document 
number and version (for internal use 
only). 
Kelly Maslin 
5/12/2017 

 
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TABLE OF CONTENTS 
TABLE OF APPENDICES ......................................................................................................... 9 
LIST OF TABLES ...................................................................................................................... 9 
LIST OF FIGURES .................................................................................................................... 9 
LIST OF ABBREVIATIONS ..................................................................................................... 10 
STUDY SYNOPSIS ................................................................................................................. 13 
1 
Introduction ...................................................................................................................... 18 
2 
Indications for Use ........................................................................................................... 18 
3 
Device Description and Theory of Operation ................................................................... 18 
4 
Device Testing ................................................................................................................. 20 
4.1 
Device Testing: Bench ........................................................................................... 20 
4.2 
Device Testing: In Vivo .......................................................................................... 20 
5 
Study Design .................................................................................................................... 20 
6 
Study Population .............................................................................................................. 23 
7 
Number of Clinical Sites and Subjects ............................................................................. 23 
8 
Study Duration ................................................................................................................. 23 
9 
Study Objectives .............................................................................................................. 23 
9.1 
Primary Study Objective ........................................................................................ 23 
9.2 
Secondary Study Objectives ................................................................................. 23 
10 Clinical Study Endpoints .................................................................................................. 24 
10.1 Primary Study Endpoints ....................................................................................... 24 
10.2 Secondary Study Endpoints .................................................................................. 24 
10.3 Powered Secondary Endpoint ............................................................................... 24 
11 Inclusion Criteria .............................................................................................................. 24 
12 Exclusion Criteria ............................................................................................................. 25 
13 Data Analysis and Statistical Issues/Justification for Study design ................................. 26 
13.1 General Statistical Analysis Plan: .......................................................................... 26 
13.2 Analysis Populations ............................................................................................. 26 
13.2.1 
Intent-to-treat: All Randomized Subjects ................................................ 26 
13.2.2 
As Treated: All Treated Subjects ............................................................ 26 
13.3 Study Hypothesis ................................................................................................... 27 
13.3.1 
Short Term Support: ............................................................................... 27 
13.3.2 
Long Term Support: ................................................................................ 27 
13.4 Randomization ....................................................................................................... 28 
13.5 Sample Size .......................................................................................................... 28 
13.5.1 
Assumptions ........................................................................................... 28 
13.5.2 
Short Term Indication ............................................................................. 28 
13.5.3 
Long Term Indication .............................................................................. 29 
13.6 Early Safety Assessment ....................................................................................... 29 

 
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13.7 Analysis of Primary Endpoint ................................................................................. 29 
13.7.1 
Primary Endpoint Stratified by Components of the Composite Endpoint 30 
13.7.2 
Effect of Site Bias on the Primary Endpoint ............................................ 30 
13.7.3 
Unblinded Interim Efficacy Analysis (Adaptive Design) .......................... 30 
13.8 Subgroup Analysis ................................................................................................. 30 
13.9 Analysis of Survival and Subject Outcome ............................................................ 31 
13.10 Analysis of Adverse Events ................................................................................... 31 
13.11 Analysis of Device Malfunctions ............................................................................ 31 
13.12 Analysis of Pre-Implant Data ................................................................................. 31 
13.13 Analysis of Implant and Discharge Data ................................................................ 31 
13.14 Analysis of Secondary Endpoints .......................................................................... 32 
13.14.1 Pump Hemodynamics ............................................................................. 32 
13.14.2 Laboratory values ................................................................................... 32 
13.14.3 Rehospitalization .................................................................................... 32 
13.14.4 Reoperations .......................................................................................... 32 
13.15 Analysis of Functional Status ................................................................................ 32 
13.15.1 NYHA ...................................................................................................... 32 
13.15.2 Six Minute Walk Test .............................................................................. 32 
13.16 Analysis of Quality of Life ...................................................................................... 33 
13.16.1 EQ-5D-5L ................................................................................................ 33 
13.16.2 KCCQ ..................................................................................................... 33 
13.17 Powered secondary analysis: ................................................................................ 33 
14 Adverse Events (AE) ........................................................................................................ 34 
14.1 Adverse Events ..................................................................................................... 34 
14.2 Serious Adverse Event (SAE) ............................................................................... 34 
15 Unanticipated Adverse Device Effects (UADE) ............................................................... 34 
16 Study Procedures and Assessments ............................................................................... 35 
16.1 Screening and Enrollment ..................................................................................... 35 
16.2 Baseline Assessments .......................................................................................... 35 
16.3 Implant ................................................................................................................... 36 
16.4 Post Op Day 1 (+/- 1 Day) ..................................................................................... 36 
16.5 1 Week Post-implant (+/- 1 Day) ........................................................................... 36 
16.6 Discharge (-1 day) ................................................................................................. 37 
16.7 Subject Follow-up Assessments ............................................................................ 38 
16.7.1 
Clinic Follow-up Post-implant: 30 Days (+/- 7 days) for 1 month 
assessment, 90 Days (+/- 30 days) for 3 month assessment, and 180 
days (+/- 30 days) for 6 month assessment............................................ 38 
16.7.2 
Clinic Follow-up Post-implant: 360 Days (+/- 30 days) for 12 month 
assessment, 540 Days (+/- 30 days) for 18 month assessment, and 720 
Days (+/- 30 days) for 24 month assessment ......................................... 39 
16.8 Additional Data Collection: .................................................................................... 40 
16.8.1 
Pump Log Files ....................................................................................... 40 
16.8.2 
Chest X-Rays .......................................................................................... 40 

 
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16.8.3 
Health Economics Data .......................................................................... 40 
17 Anticoagulation ................................................................................................................ 40 
18 Infection Control Guidelines ............................................................................................. 40 
19 Blood Pressure guidelines ............................................................................................... 41 
20 Post-mortem Examination ................................................................................................ 41 
21 Device Retrieval and analysis .......................................................................................... 41 
22 Subject Withdrawal .......................................................................................................... 41 
23 Risks ................................................................................................................................ 42 
24 Mitigations ........................................................................................................................ 43 
25 Benefits ............................................................................................................................ 43 
26 Ethical Requirements ....................................................................................................... 44 
26.1 Informed Consent .................................................................................................. 44 
26.2 IRB Review ............................................................................................................ 44 
26.3 Confidentiality ........................................................................................................ 44 
27 Protocol Deviations .......................................................................................................... 45 
28 Protocol Amendments ...................................................................................................... 45 
29 Data Collection, Case Report Forms and Record Keeping Requirements ...................... 45 
29.1 Database and Electronic Case Report Forms (eCRFs) ........................................ 45 
29.2 Device Accountability Records .............................................................................. 45 
29.3 Source Documentation .......................................................................................... 46 
29.4 Maintenance of Study Documentation ................................................................... 46 
29.5 Regulatory Reporting Requirements ..................................................................... 47 
29.5.1 
Site Reporting ......................................................................................... 47 
29.5.2 
Sponsor Reporting .................................................................................. 47 
29.6 Retention of Records ............................................................................................. 47 
29.7 Laboratory Accreditation and Normal Values ........................................................ 47 
30 Insurance ......................................................................................................................... 47 
31 Quality Control ................................................................................................................. 48 
31.1 Independent Monitoring Boards ............................................................................ 48 
31.1.1 
Data Safety Monitoring Board (DSMB): .................................................. 48 
31.1.2 
Clinical Events Committee (CEC): .......................................................... 48 
31.2 Investigator Selection ............................................................................................ 48 
31.3 Site Selection ......................................................................................................... 48 
31.4 Site Staff Training .................................................................................................. 48 
31.5 Monitoring .............................................................................................................. 49 
31.5.1 
Pre-Investigational (Initiation) Visit: ......................................................... 49 
31.5.2 
Periodic Monitoring Visits: ...................................................................... 49 
31.5.3 
Study Closeout Activities: ....................................................................... 50 

 
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31.6 Investigator and/or Study Site Termination/Suspension ........................................ 50 
31.7 Early Study Termination ........................................................................................ 50 
32 Emergency Contacts ........................................................................................................ 51 
33 Publication Policy ............................................................................................................. 51 
34 MOMENTUM 3 IDE Study Visit Schedule ....................................................................... 52 
35 References ....................................................................................................................... 55 
 

 
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TABLE OF APPENDICES 
Appendix 
Contents 
1 
Anticipated Adverse Event Definitions 
2 
INTERMACS Profile/Classification 
3 
NYHA Classification 
4 
6MWT Protocol 
5 
Modified Rankin Score 
6 
INTERMACS Definitions for Intended Use of Device 
 
 
 
 
List of Tables 
Table 1 – Expected Incidence Rate of Adverse Events .............................................................. 42 
Table 2 – Schedule of Events for Randomized Subjects ............................................................ 52 
 
 
 
List of Figures 
Figure 1 – HeartMate 3 System during Battery-powered Operation ........................................... 19 
Figure 2 – MOMENTUM 3 IDE Study Flow ................................................................................ 22 
 
 
 
 

 
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List of Abbreviations 
6MWT ............... Six-Minute Walk Test 
AAA .................. Abdominal Aortic Aneurysm 
ACE .................. Angiotensin Converting Enzyme 
ADL .................. Activities of Daily Living 
AE .................... Adverse Event 
AHA .................. American Heart Association 
AI ...................... Aortic Insufficiency 
AICD ................. Automatic Internal Cardiac Defibrillator 
AIMDD .............. Active Implantable Medical Device Directive 
ALT ................... Alanine Aminotransferase 
aPTT ................ Activated Partial Thromboplastin Time 
ARB .................. Angiotensin Receptor Blocker 
AST .................. Aspartate Aminotransferase 
AT ..................... As Treated 
AV .................... Aortic Valve 
BNP .................. B-type Natriuretic Peptide 
BSA .................. Body Surface Area 
BTT .................. Bridge to Cardiac Transplantation 
BUN .................. Blood Urea Nitrogen (Urea, blood) 
CEC .................. Clinical Events Committee 
CFR .................. Code of Federal Regulations 
CI ...................... Cardiac Index 
CIP ................... Clinical Investigation Plan 
CK .................... Creatine Kinase 
CNS .................. Central Nervous System 
COPD ............... Chronic Obstructive Pulmonary Disease 
CPB .................. Cardiopulmonary Bypass 
CRF .................. Case Report Form 
CRP .................. C-reactive Protein 
CRT .................. Cardiac Resynchronization Therapy 
CSA .................. Clinical Study Agreement 
CT .................... Computed Tomography 
CV .................... Cardiovascular 
CVP .................. Central Venous Pressure 
DT .................... Destination Therapy 
DSMB  .............. Data Safety Monitoring Board 
ECG ................. Electrocardiogram 
eCRF ................ Electronic Case Report Form 
EDC .................. Electronic Data Capture 
EEG .................. Electroencephalogram 
eGFR ................ Glomerular Filtration Rate  
EQ-5D-5L ......... EuroQol Health Utility Index 
FDA .................. U.S. Food and Drug Administration 
FEV1 ............................Forced Expiratory Volume in One Second 
FVC .................. Forced Vital Capacity 

 
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List of Abbreviations 
FWA ................. Federal Wide Assurance 
GI ..................... Gastrointestinal 
GLP .................. Good Laboratory Practices 
H0 ..................... Null Hypothesis 
HA ..................... Alternative Hypothesis 
HF .................... Heart Failure 
HIE ................... Hypoxic-Ischemic Injury 
HM II ................. HeartMate II 
HM3 .................. HeartMate 3 
HR .................... Heart Rate 
Hs-CRP ............ High Sensitivity C-reactive Protein 
IABP ................. Intra Aortic Balloon Pump 
IB ...................... Investigator’s Brochure 
ICD ................... Internal Cardiac Defibrillator 
ICH ................... Intracranial Hemorrhage 
ICF ................... Informed Consent Form 
ICU ................... Intensive Care Unit 
IDE ................... Investigational Device Exemption 
IFU ................... Instructions For Use 
INTERMACS .... Interagency Registry for Mechanically Assisted Circulatory Support 
INR ................... International Normalized Ratio 
IRB ................... Institutional Review Board 
ITT .................... Intent-to-treat 
KCCQ ............... Kansas City Cardiomyopathy Questionnaire 
LDH .................. Lactic Acid Dehydrogenase 
LOS .................. Length of Stay 
LV ..................... Left Ventricle 
LVAD ................ Left Ventricular Assist Device 
LVAS ................ Left Ventricular Assist System 
LVEDD ............. Left Ventricular End Diastolic Diameter 
LVEF ................ Left Ventricular Ejection Fraction 
LVESD ............. Left Ventricular End Systolic Diameter 
MB .................... Myocardial Band 
MCS ................. Mechanical Circulatory Support 
MCS ................. Mechanical Circulatory Support Device 
MPU ................. Mobile Power Unit 
MR .................... Mitral Regurgitation 
NT-ProBNP ...... N terminal B-type natriuretic peptide  
NYHA ............... New York Heart Association 
OMM ................ Optimal Medical Management 
PHgb ................ Plasma Free Hemoglobin 
PA .................... Posterior-anterior 
PI ...................... Principal Investigator 
PMA  ................ Premarket Approval 
PRBC ............... Packed Red Blood Cells 

 
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List of Abbreviations 
PT ..................... Prothrombin Time 
PTT .................. Partial Thromboplastin Time 
PVD .................. Peripheral Vascular Disease 
PVR .................. Pulmonary Vascular Resistance 
RCT .................. Randomized Controlled Trial 
RV .................... Right Ventricle 
RVAD ............... Right Ventricular Assist Device 
SAE .................. Serious Adverse Event 
SBP .................. Systolic Blood Pressure 
SHFM ............... Seattle Heart Failure Model 
Thoratec ........... Thoratec Corporation 
tPA……………..Tissue Plasminogen Activator 
TR .................... Tricuspid Regurgitation 
UADE ............... Unanticipated Adverse Device Effect 
UNOS………….United Network for Organ Sharing 
VAD .................. Ventricular Assist Device 
VAS .................. Visual Analogue Scale 
WBC ................. White Blood Cells 
WMA ................ World Medical Association 
 
 
 
 
 
 
 

 
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STUDY SYNOPSIS 
Device 
HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) 
Indications for 
Use 
The HM3 LVAS is intended to provide hemodynamic support in patients with 
advanced, refractory left ventricular heart failure; either for short term support, such 
as a bridge to cardiac transplantation (BTT) or myocardial recovery, or as long term 
support, such as destination therapy (DT).  The HM3 is intended for use inside or 
outside the hospital. 
Study 
Objective 
The objective of the study is to evaluate the safety and effectiveness of the HM3 
LVAS by demonstrating non-inferiority to the HM II LVAS (HM II) when used for the 
treatment of advanced, refractory, left ventricular heart failure.  
Study 
Population 
Advanced Heart Failure New York Heart Association (NYHA) Class III patients with 
dyspnea upon mild physical activity, or NYHA Class IV who are refractory to 
advanced heart failure management. 
Study Design 
The study will be a prospective, multi-center, unblinded, randomized, controlled, 
non-inferiority study comparing the HM3 LVAS to the HM II LVAS.  The study will be 
conducted as a staged pivotal study that includes a pre-specified early assessment 
for safety. 
Other key elements include: 
− 
Up to 5 centers in the United States (U.S.) will be initiated to enroll up to 10 
randomized HM3 Subjects.  A pre-specified analysis for safety will be 
performed after the first 10 randomized HM3 Subjects have completed 30 
days of follow-up.  The results of this early safety analysis will be reviewed 
by the Data Safety Monitoring Board (DSMB), after which the DSMB report, 
along with supporting safety data from the HM3 CE Mark study will be sent 
to FDA as an IDE supplement, with a request to gain full IDE approval to 
expand the study to up to a total of 60 centers in the U.S.  The first 5 U.S. 
centers will continue to enroll up to a total of 30 subjects (including those in 
the early safety analysis) during FDAs review of this IDE Supplement. 
− 
An adaptive design will be used, if required to adjust the sample size at a 
pre-specified time during the study. 
− 
Primary Endpoint Analysis 
− 
Perform an analysis and submit the Premarket Approval (PMA) when 
the specified number of Subjects complete 6 months of support for a 
short term indication 
− 
Perform an analysis and submit a PMA supplement when the specified 
number of Subjects complete 24 months of support for a long term 
indication 
− 
Powered Secondary Endpoint Analysis 
− 
Once the Subjects have been enrolled for the primary endpoint 
analysis, randomization will continue until sufficient Subjects have 
been enrolled to evaluate a pre-specified powered secondary 
endpoint. 
− 
Analysis of the pre-specified secondary endpoint will be used to 
update HM3 labeling. 
Control Group 
The HM II will serve as the control group. Subjects will be randomized 1 HM3 to 1 
HM II. 

 
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STUDY SYNOPSIS 
Primary Study 
Endpoints 
1. Short Term Indication: 
a. Composite of Survival to transplant, recovery or 6 months of LVAD 
support free of debilitating stroke (Modified Rankin Score > 3) or 
reoperation to replace the pump. 
2. Long Term Indication: 
a. Composite of Survival to transplant, recovery or 24 months of LVAD 
support free of debilitating stroke (Modified Rankin Score > 3) or 
reoperation to replace the pump. 
Secondary 
Study 
Endpoints 
The following secondary objectives will be evaluated:   
1. Quality of Life as measured by EuroQoL 5D-5L (EQ-5D-5L) and Kansas 
City Cardiomyopathy Questionnaire (KCCQ) 
2. Functional status as measured by the 6-minute walk test (6MWT) and 
NYHA classification 
3. Frequency and incidence of all re-operations  
4. Frequency and incidence of all rehospitalizations 
5. Frequency, incidence and rates of pre-defined anticipated adverse events. 
6. Frequency and incidence of device malfunctions  
Pre- Specified 
Powered 
Secondary 
Endpoint 
In addition to powering the study on the primary endpoints for PMA approval, the 
study will pre-specify a powered secondary endpoint to evaluate incidence of pump 
replacements at 24 months.  
Sample Size 
Total sample size = 1028 (Randomized 1:1). 
Study 
Hypothesis 
and Sample 
Size 
Short Term Indication Hypothesis: 
− 
HM3 non-inferior to HM II at 6 months 
− 
Assumes 87% composite success rate for HM3 and 85% for HM II at 6 
months. 
− 
294 Subjects provides 80% power to show non-inferiority when the margin 
of non-inferiority is 10% and alpha = 0.025.  Sample size accounts for early 
transplants. 
Long Term Indication Hypothesis:  
− 
HM3 non-inferior to HM II at 24 months 
− 
Assumes 55% composite success at 24  months for the HM3 arm and 50% 
for the HM II arm 
− 
366 Subjects provides 80% power to show non-inferiority when the margin 
of non-inferiority is 10% and alpha = 0.025.  Sample size accounts for early 
transplants. 
 
Pre-Specified  Secondary Analysis of Pump Replacements 
− 
When enrollment to evaluate the primary objective is complete, 
randomization will continue to enroll  Subjects to determine if the pump 
replacement rate for HM3 is superior to HM II at 24 months 
− 
The pump replacement rate for the HM II is about 7% at 24 months in the 
United States.   
− 
In order to determine if the rate of HM3 pump replacements have been 
reduced to 3% at 24 months, 1028 Subjects will be required  (power=0.8; 
alpha = 0.05, two-sided).  This will require the randomization of 662 
additional Subjects. 
Study Duration 
All randomized Subjects will be followed for 24 months or to outcome (transplant, 
explant, or death), whichever occurs first.  

 
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STUDY SYNOPSIS 
Inclusion 
Criteria 
 
1) Subject or legal representative has signed Informed Consent Form (ICF) 
2) Age ≥ 18 years 
3) BSA  ≥ 1.2 m2 
4) NYHA Class III with dyspnea upon mild physical activity, or NYHA Class IV  
5) LVEF ≤ 25% 
6) a) Inotrope dependent 
                          OR 
b) CI < 2.2 L/min/m2, while not on inotropes and subjects must also meet one of 
the following:  
• On Optimal Medical Management (OMM), based on current heart failure 
practice guidelines for at least 45 out of the last 60 days and are failing 
to respond 
• Advanced Heart Failure for at least 14 days AND dependent on intra-
aortic balloon pump (IABP) for at least 7 days  
7) Females of child bearing age must agree to use adequate contraception 

 
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Exclusion 
Criteria 
1) Etiology of heart failure (HF) due to or associated with uncorrected thyroid 
disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or 
restrictive cardiomyopathy 
2) Technical obstacles which pose an inordinately high surgical risk, in the 
judgment of the investigator 
3) Existence of ongoing mechanical circulatory support (MCS) other than IABP 
4) Positive pregnancy test if of childbearing potential 
5) Presence of mechanical aortic valve that will not be either converted to a 
bioprosthesis or oversewn at the time of LVAD implant 
6) History of any organ transplant 
7) Platelet count < 100,000 x 103/L (< 100,000/ml) 
8) Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial 
issues that are likely to impair compliance with the study protocol and LVAS 
management 
9) History of confirmed, untreated AAA  > 5 cm in diameter within 6 months of 
enrollment 
10) Presence of an active, uncontrolled infection 
11) Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-
operative therapy the investigator will require based upon the patients’ health 
status 
12) Presence of any one of the following risk factors for indications of severe end 
organ dysfunction or failure: 
a) An INR ≥ 2.0 not due to anticoagulation therapy 
b) Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver 
cirrhosis 
c) History of severe chronic obstructive pulmonary disease (COPD) defined 
by FEV1/FVC < 0.7, and FEV1 <50% predicted 
d) Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that 
is unresponsive to pharmacologic intervention 
e) History of stroke within 90 days prior to enrollment, or a history of 
cerebrovascular disease with significant (> 80%) uncorrected carotid 
stenosis 
f) 
Serum creatinine ≥ 221 umol/L (2.5 mg/dl) or the need for chronic renal 
replacement therapy 
g) Significant peripheral vascular disease (PVD) accompanied by rest pain or 
extremity ulceration 
13) Patient has moderate to severe aortic insufficiency without plans for correction 
during pump implant 
14) Pre albumin < 150 mg/L (15mg/dL) or Albumin < 30g/L (3 g/dL) (if only one 
available) ; pre albumin < 150 mg/L (15mg/dL) and Albumin < 30g/L (3 g/dL) (if 
both available)   
15) Planned Bi-VAD support prior to enrollment 
16) Patient has known hypo or hyper coagulable states such as disseminated 
intravascular coagulation and heparin induced thrombocytopenia 
17) Participation in any other clinical investigation that is likely to confound study 
results or affect the study 
18) Any condition other than HF that could limit survival to less than 24 months 
Study Follow-
up Intervals  
Screening, Baseline, Implant, Post-op Day 1, 1 week, Discharge, Month(s) 1, 3, 6, 
12, 18 and 24.  

 
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STUDY SYNOPSIS 
Data Collection 
A 21 CFR part 11 compliant Electronic Data Capture (EDC) system will be used to 
collect data. 
Statistical 
Analysis 
Baseline data will be analyzed using Fisher’s exact test and unpaired t-tests as 
appropriate.  The HM3 will be considered non-inferior to the HM II for short term 
and long term indications if the lower 95% confidence limit of the difference 
between the success for the HM3 and HM II is greater than the non-inferiority 
margin of -10%. Once non-inferiority is inferred, the data will be analyzed for 
superiority using closed testing methods.  
Differences in survival between treatment groups will be analyzed using the Kaplan-
Meier product-limit method.  
Safety, including device malfunctions, will be reported as incidence and event rate 
per patient year of support.  A time to event analysis will also be performed.  
Comparison of adjudicated adverse events between HM3 and the HM II control 
group will be performed using Fisher’s exact test or Poisson regression, as 
appropriate. 
Quality of Life and six minute walk data will be analyzed using mixed models.   
Subanalyses of the primary endpoints, survival, adverse events, and quality of life 
will also be performed and will include gender, ethnicity, age, VO2 Max, and 
intended use of the device at the time of implant as defined by INTERMACS.  
In addition to the primary outcome, the study will be powered to test if HM3 pump 
reliability is superior to HM II by analyzing the incidence of pump replacement.  The 
percentage of HM3 pump replacements will be compared to HM II using Fisher’s 
exact test. 
 
Adverse 
Events 
Anticipated adverse events will be captured using definitions described in this FDA 
approved protocol. 
Adaptive 
Design 
In case the assumptions of the study are incorrect, a pre-specified early look at the 
data will be performed by an independent statistician to determine if the study 
requires adjustment to the sample size.  The adaptive design analysis will be 
performed to evaluate the conditional power.  
Number of 
Investigational 
Sites 
Up to 70 U.S. sites 

 
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1 
INTRODUCTION 
Over the last decade, mechanical circulatory support with left ventricular assist devices 
(LVADs) have become an important therapy for patients in advanced stage heart failure.  
The HeartMate® II (HM II) LVAD is a rotary axial-flow pump that has been approved by 
the U.S. Food and Drug Administration (FDA) for New York Heart Association Class 
(NYHA) IIIB/IV patients as a bridge to cardiac transplantation, and as permanent 
destination therapy.  Numerous publications have documented the success of the HM II 
in extending and improving the quality of patient’s lives(1, 2, 3, 9).  Adverse events 
associated with the HM II have included GI bleeding, pump thrombosis, and driveline 
issues which, in some cases, have resulted in pump replacement.  
 
HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) is the next generation of 
mechanical support device.  The purpose of this study is to evaluate the safety and 
effectiveness of the HM3 LVAS.  This multicenter study is designed to determine if the 
HM3 provides similar survival and quality of life benefits as the HM II by using a 
prospective, randomized, controlled, non-inferiority study design.  Additional potential 
benefits of the HM3, such as reduced adverse events, will also be evaluated in a 
descriptive manner.  
 
2 
INDICATIONS FOR USE 
The HM3 LVAS is intended to provide hemodynamic support in patients with advanced 
refractory left ventricular heart failure; either for short term support, such as a bridge to 
cardiac transplantation (BTT) or myocardial recovery, or as long term support, such as 
destination therapy (DT).  The HM3 LVAS is intended for use inside or outside the 
hospital. 
 
3 
DEVICE DESCRIPTION AND THEORY OF OPERATION  
The HeartMate 3 LVAS is a set of equipment and materials that together comprise a 
medical device designed to provide therapeutic benefit to those afflicted with advanced 
heart failure.  In service, the LVAS assumes some or all of the workload of the left 
ventricle, thereby restoring the patient's systemic perfusion while palliating the 
underlying pathology.  The LVAS features a Left Ventricular Assist Device (LVAD), a 
centrifugal magnetically levitated pump intended for long term implantation in such 
patients, an extracorporeal Controller, plus all of the features, controls, attachments, 
interfaces, power sources, supporting equipment, labeling, and tools required to achieve 
the desired therapeutic benefit. 
 
The LVAS may be used in either of two configurations.  First, line power may be utilized 
through the Power Module or Mobile Power Unit (MPU) to run the LVAD indefinitely, 
convenient for sedentary or sleeping periods.  Second, portable Battery power may be 
utilized for limited periods, convenient for active periods.  Due to the bifurcation of the 
Patient Cable, switching among these configurations or from one set of Batteries to 
another (as when one set has been depleted and a fully charged set is available) may be 
accomplished without interrupting LVAS function.  Whenever the Power Module is used 

 
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a System Monitor may also be used as a means of viewing operating conditions, 
changing operating parameters, and manipulating stored data. 
 
While Subjects are in the hospital, either the Power Module or MPU can be used.  
However, Subjects implanted with HM3 will be discharged from the hospital with the 
MPU, without the system monitor, as their primary source of power. Subjects implanted 
with HMII can be discharged with either the MPU or Power Module. 
 
The HeartMate 3 LVAD is part of the HeartMate 3 LVAS.  See Figure 1.  The LVAD is a 
blood pump intended for long term implantation in the thorax of patients with advanced 
heart failure.  The LVAD is surgically connected to the patient's circulatory system via an 
Inflow Cannula placed into the left ventricular apex, and an Outflow Graft anastomosed 
to the ascending aorta.  Detailed surgical, patient management and storage and 
handling instructions can be found in the HM3 Instructions For Use (IFU).  
 
 
 
Figure 1 – HeartMate 3 System during Battery-powered Operation 
 
 
 
 
The HM3 LVAD contains an Inflow Cannula, a Pump Cover, a Lower Housing, a Screw 
Ring to attach the Pump Cover to the Lower Housing, a Motor, the Outflow Graft, and a 
Pump Cable. 
 
The HeartMate 3 Controller is also part of the HM3 LVAS.  The Controller is an 
extracorporeal interface device that receives power from the Power Module, Mobile 

 
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Power Unit, or portable Batteries, and appropriately delivers that power to the HM3 
LVAD.  It is the primary user interface and has several important functions: 
• Operating condition display, 
• Source of audible and visible alarms, 
• Communication link for transferring event/period log and alarm information, and 
• Battery backup in the case of full power disconnection. 
 
The HM3 LVAD is assembled in Thoratec Corporation’s manufacturing facility in Zurich, 
Switzerland.  All other HM3 components and accessories are manufactured at Thoratec 
Corporation’s manufacturing facility in Pleasanton, California, U.S.A. 
 
A complete list of HM33 LVAS components and accessories, including model and/or 
serial/lot numbers is included in the HM3 IFU. 
 
For additional information about this product, including information about the biologically 
active materials used, please see the HM3Investigator’s Brochure (IB). 
 
4 
DEVICE TESTING 
4.1 
Device Testing: Bench  
The HeartMate 3 LVAD/LVAS is an implantable long term support device/system.  As 
such, it has been designed in compliance with all applicable FDA and international 
standards4,5,6,7.  The device/system has been subjected to a comprehensive verification 
and validation effort to ensure its safety including evaluation of biocompatibility, sterility 
and long term reliability.  Please refer to the HeartMate 3 Investigator’s Brochure for a 
more detailed description.  
4.2 
Device Testing: In Vivo 
Extensive testing in animals has been done providing assurance to proceed with the use 
of the HM3 LVAS in humans. 
 
In vivo studies were conducted to evaluate the safety of the HeartMate 3 LVAS.  The in 
vivo tests verified:  
• Surgical human factors and usability data 
• Device performance characterization 
• Biological effects (thrombosis, hemolysis, bleeding) 
 
Testing was conducted under Good Laboratory Practices (GLP) Guidelines8.  Please 
reference the Investigator’s Brochure for additional information. 
 
5 
STUDY DESIGN 
The study will be prospective, multi-center, unblinded, randomized, controlled, non-
inferiority study, comparing the HM3 LVAS to the HM II LVAS.  Short term use of the 
device will be evaluated when Subjects have been supported for 6 months.  Long term 
use of the device will be evaluated when Subjects have been followed for 24 months.  

 
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Subjects who receive a device exchange to any device other than HM II or HM3, at any 
time during the study, will be withdrawn from the study and will not be followed. 
 
This study will be conducted as a staged pivotal study that includes a pre-specified early 
assessment for safety that is consistent with FDA’s new Guidance for staged approval 
process, and in accordance with applicable local and federal regulations as specified in 
21 CFR part 812. 
 
During the early safety phase of the pivotal study, up to 5 centers in the United States 
(U.S.) will be initiated to enroll up to 10 randomized HM3 Subjects.  A pre-specified 
analysis for safety will be performed after the first 10 randomized HM3 Subjects have 
completed 30 day follow-up.  The results of this early safety analysis will be reviewed by 
the Data Safety Monitoring Board (DSMB), after which the DSMB report, along with 
supporting safety data from the HM3 CE Mark study will be sent to FDA as an IDE 
supplement, with a request to gain full IDE approval to expand the study to up to a total 
of 60 centers in the U.S.  The first 5 U.S. centers will continue to enroll up to a total of 30 
subjects (including those in the early safety analysis) during FDA’s review of this IDE 
Supplement. 
 
The study will include an adaptive design which will be used, if required to adjust the 
sample size at a pre-specified time during the study.  
 
In addition to the primary study endpoint, the study will include a powered secondary 
endpoint to provide supplemental data for HM3 labeling.  
 
 
 

 
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Figure 2 – MOMENTUM 3 IDE Study Flow 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total sample size = 1028 (randomized 1:1). 
 
 
 
 
 
 
 
Subject Meets HMIII 
All Comers
Entrance Criteria?
Screen Failure
No
Yes
 HM III  Pivotal 
Study Sites
(n=70)
Randomized 1HM III:1HM II
PMA Supplement
1028 Subjects for secondary 
endpoint analysis with 24 mos 
follow-up
ICF
 Original PMA
Short Term  indication at 6 mos
N= 294
PMA Supplement
Long Term indication at 24 mos
N= 366
Continue enrolling additional      
72 Subjects  
Continue enrolling additional 662
 Subjects for secondary endpoint 

 
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6 
STUDY POPULATION 
Advanced heart failure NYHA Class III patients with dyspnea upon mild physical activity, 
or NYHA Class IV patients who are refractory to advanced heart failure management. 
7 
NUMBER OF CLINICAL SITES AND SUBJECTS 
The study will be conducted in up to 70 clinical sites.  The total sample size for this study 
is 1028 Subjects.  Three hundred and sixty-six (366) Subjects will be enrolled and 
randomized to evaluate the primary endpoint.  The data from the Subjects randomized 
for the primary endpoint will be used for PMA submission for the Short Term and Long 
Term indications.  An additional 662 Subjects will be randomized to achieve 1028 
Subjects needed for the powered secondary endpoint analysis.  The data from the 
powered secondary endpoint will be used to update labeling under a Supplemental 
PMA.  Refer to Figure 2.  
 
8 
STUDY DURATION 
It is anticipated that it will take approximately 6 months to complete the early safety 
assessment phase of the study.  After that, the first 5 U.S. centers will continue to enroll 
up to a total of 30 subjects (including those in the early safety analysis) while the IDE 
Supplement is under review with the FDA for full IDE approval to expand the study to 60 
centers. 
 
It is anticipated that it will take approximately 42 months to complete enrollment and 
follow up for the primary endpoint analysis of the study for the short and long term 
evaluation of the device.  All randomized Subjects needed for the primary endpoint 
analysis will be followed for 24 months or to outcome (transplant, explant, or death), 
whichever occurs first. 
 
It is anticipated that it will take approximately 13 additional months to enroll the 
randomized Subjects for the powered secondary endpoint.  All randomized Subjects that 
are not required for the primary endpoint analysis will be followed for 24 months or to 
outcome, whichever occurs first. 
 
9 
STUDY OBJECTIVES 
9.1 
Primary Study Objective 
The primary objective of the study is to evaluate the safety and effectiveness of the HM3 
LVAS by demonstrating non-inferiority to the HM II LVAS when used for the treatment of 
advanced, refractory, left ventricular heart failure. 
9.2 
Secondary Study Objectives 
Secondary objectives include: 
• Assessment of adverse events 
• Assessment of rehospitalizations and re-operations 
• Assessment of quality of life and functional status 
• Assessment of clinical reliability, device malfunctions, and device failures

 
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10 
CLINICAL STUDY ENDPOINTS 
10.1 
Primary Study Endpoints 
• 
Composite of survival to transplant, recovery or 6 months of LVAD support free of 
debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump 
• 
Composite of survival to transplant, recovery or 24 months of LVAD support free of 
debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump 
 
The 6 month composite data will be submitted for the short term indication and the 24 
month composite data will be submitted for the long term indication. 
10.2 
Secondary Study Endpoints 
• 
Quality of Life: Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) and 
the Kansas City Cardiomyopathy Questionnaire (KCCQ) 
• 
Functional Status: Functional status as measured by the Six Minute Walk Test 
(6MWT) and by NYHA Classification. 
• 
Adverse Events: Frequency, incidence and rates of pre-defined anticipated adverse 
events 
• 
Device Malfunctions: Frequency and incidence of device malfunctions 
• 
Reoperations: Frequency and incidence of all reoperations   
• 
Rehospitalizations: Frequency and incidence of all rehospitalizations 
10.3 
Powered Secondary Endpoint 
• 
Incidence of pump replacements at 24 months 
 
11 
INCLUSION CRITERIA 
1) 
Subject or legal representative has signed Informed Consent Form (ICF) 
2) 
Age ≥ 18 years 
3) 
BSA ≥ 1.2 m2 
4) 
NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV 
5) 
LVEF ≤ 25%  
6) 
a) Inotrope dependent 
  
 
OR 
b) CI < 2.2 L/min/m2, while not on inotropes and subjects must also meet one of 
the following: 
• On optimal medical management (OMM), based on current heart failure practice 
guidelines for at least 45 out of the last 60 days and are failing to respond 
• Advanced heart failure for at least 14 days AND dependent on intra-aortic 
balloon pump (IABP) for at least 7 days,  
7) 
Females of child bearing age must agree to use adequate contraception

 
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12 
EXCLUSION CRITERIA 
1) 
Etiology of HF due to or associated with uncorrected thyroid disease, obstructive 
cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy 
2) 
Technical obstacles which pose an inordinately high surgical risk, in the judgment of 
the investigator 
3) 
Existence of ongoing mechanical circulatory support (MCS) other than IABP 
4) 
Positive pregnancy test if of childbearing potential 
5) 
Presence of mechanical aortic cardiac valve that will not be either converted to a 
bioprosthesis or oversewn at the time of LVAD implant 
6) 
History of any organ transplant 
7) 
Platelet count < 100,000 x 103/L (< 100,000/ml) 
8) 
Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial 
issues that are likely to impair compliance with the study protocol and LVAS 
management 
9) 
History of confirmed, untreated Abdominal Aortic Aneurysm (AAA) > 5 cm in 
diameter within 6 months of enrollment 
10) Presence of an active, uncontrolled infection 
11) Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative 
therapy that the investigator will require based upon the patients’ health status 
12) Presence of any one of the following risk factors for indications of severe end organ 
dysfunction or failure: 
a) An INR ≥ 2.0 not due to anticoagulation therapy 
b) Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis 
c) History of severe chronic obstructive pulmonary disease (COPD) defined by 
FEV1/FVC < 0.7, and  FEV1 <50% predicted 
d) Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is 
unresponsive to pharmacologic intervention 
e) History of stroke within 90 days prior to enrollment, or a history of 
cerebrovascular disease with significant (> 80%) uncorrected carotid artery 
stenosis 
f) Serum Creatinine ≥ 221umol/L (2.5 mg/dl) or the need for chronic renal 
replacement therapy 
g) Significant peripheral vascular disease (PVD) accompanied by rest pain or 
extremity ulceration 
13) Patient has moderate to severe aortic insufficiency without plans for correction 
during pump implant 
14) Pre albumin < 150 mg/L (15mg/dL) or Albumin < 30g/L (3 g/dL) (if only one 
available); pre albumin < 150 mg/L (15mg/dL) and Albumin < 30g/L (3 g/dL) (if both 
available) 
15) Planned Bi-VAD support prior to enrollment  
16) Patient has known hypo or hyper coagulable states such as disseminated 
intravascular coagulation and heparin induced thrombocytopenia 

 
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17) Participation in any other clinical investigation that is likely to confound study results 
or affect the study 
18) Any condition other than HF that could limit survival to less than 24 months 
 
13 
DATA ANALYSIS AND STATISTICAL ISSUES/JUSTIFICATION FOR STUDY 
DESIGN 
13.1 
General Statistical Analysis Plan: 
The HM3 IDE study will investigate the safety and effectiveness of the HM3 LVAS for 
short term hemodynamic support, such as a bridge to cardiac transplantation (BTT) or 
myocardial recovery, or as long term support, such as destination therapy (DT).  The 
HM3 IDE study is a prospective, multicenter, unblinded, randomized, controlled, non-
inferiority study comparing the HM3 LVAS to the HM II LVAS.  
 
In general, continuous data will be presented as the number of Subjects, mean with 
standard deviation, median, and minimum and maximum values.  Categorical data will 
be reported as frequencies and percentages.  Adverse events will also be reported as 
rates per patient year.  Only adverse events that occur after the start of the implant 
procedure will be analyzed.  Survival data will be presented using the Kaplan-Meier 
product limit method. 
 
Data will be analyzed using the intent-to-treat method (ITT) defined as all randomized 
Subjects.  Every effort will be made to avoid cross-over but in the event they occur, data 
will also be analyzed “as randomized” for efficacy analysis and “as treated” for safety 
analysis and all other secondary endpoints. 
 
Every effort will be made to collect all required data.  Missing primary endpoints will be 
imputed using multiple imputation techniques.  Missing secondary endpoints will not be 
imputed, except as described below.  A one-sided 0.025 level of significance or two-
sided 0.05 level of significance will be used to declare statistical significance as outlined 
below.  Multiplicity adjustments will not be made unless specified below. 
 
Statistical analysis will be performed using SAS version 9.1 or higher. 
13.2 
Analysis Populations 
13.2.1 
Intent-to-treat: All Randomized Subjects 
This is the primary analysis population for the primary endpoint.  Subjects are 
analyzed under the treatment to which they were randomized. 
 
13.2.2 
As Treated: All Treated Subjects 
This is the primary analysis population for the secondary endpoints.  Subjects 
are analyzed under the treatment they received. 

 
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13.3 
Study Hypothesis 
13.3.1 
Short Term Support: 
The short term study endpoint is a composite of survival to transplant, 
myocardial recovery or 6 months of support (whichever occurs first) free of a 
debilitating stroke (modified Rankin Score > 3) or reoperation to replace the 
original pump.  A Subject will be considered a success if they are: 
• Electively transplanted or explanted for myocardial recovery prior to 6 
months or 
• Alive at 6 months, and 
o Have not experienced a stroke with a modified Rankin Score > 3, and 
o Have not received a device replacement or exchange, and 
o Have not received an urgent transplant due to a LVAS malfunction. 
A Subject will be considered a failure if they: 
• Expire prior to 6 months, or 
• Experience a stroke with a modified Rankin Score > 3 prior to 6 months, or 
• Have a device replaced or exchanged or deactivated for reasons other than 
myocardial recovery prior to 6 months, or 
• Have received an urgent transplant due to a LVAS malfunction prior to 6 
months, or 
• Have withdrawn from the study for any reason prior to 6 months 
HM3 short term success rate will be compared to that of the HM II control in a 
non-inferiority manner.  The null and alternative hypotheses are: 
 
Ho:  πHM3 ≤ πHM II - Δ 
HA:  πHM3 > πHM II - Δ 
where πHM3 and πHM II are the short term success rates of HM3 and HM II, 
respectively, and where Δ is the non-inferiority margin. 
13.3.2 
Long Term Support: 
The long term study endpoint is a composite of survival to transplant, 
myocardial recovery or 24 months of support (whichever occurs first) free of a 
debilitating stroke (modified Rankin Score > 3) or reoperation to replace the 
original pump.  A Subject will be considered a success if they are: 
• Electively transplanted or explanted for myocardial recovery prior to 24 
months or 
• Alive at 24 months, and 
o Have not experienced a stroke with a modified Rankin Score > 3, and 
o Have not received a device replacement or exchange, and 
o Have not received an urgent transplant due to a device malfunction. 

 
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A Subject will be considered a failure if they: 
• 
Expire prior to 24 months, or 
• 
Experience a stroke with a modified Rankin Score > 3 prior to 24 months, or 
• 
Have a device replaced or exchanged or deactivated for any reason other 
than myocardial recovery prior to 24 months, or 
• 
Have received an urgent transplant due to a LVAS malfunction prior to 24 
months, or 
• 
Have withdrawn from the study for any reason prior to 24 months 
The 24 month success rate of the HM3 Subjects will be compared to the HM II 
control.  The null and alternative hypotheses are: 
 
Ho:  πHM3 ≤ πHM II - Δ 
HA:  πHM3 > πHM II – Δ 
where πHM3 and πHM II are the long term success rates of HM3 and HM II, 
respectively, and where Δ is the non-inferiority margin. 
13.4 
Randomization 
Subjects will be randomized in a 1:1 fashion (1 HM3: 1 HM II).  The randomization will 
be stratified by study center and blocked to maintain the 1:1 ratio over time.  
Randomization will be implemented through the Electronic Data Capture (EDC) system.  
Study centers will be allowed a maximum of 50 randomized Subjects. Centers may have 
their maximum enrollment number increased with prior Sponsor approval. An analysis 
will be conducted to determine if there is site bias.  Subjects will be considered enrolled 
in the study upon signing informed consent; all subjects will be randomized and will be 
included in the intent-to-treat analysis.  
13.5 
Sample Size 
13.5.1 
Assumptions 
• Larger gap between the rotor and pump housing in the HM3 may result in 
less thrombus than HM II 
• Larger gap between the rotor and pump housing in the HM3 may result in 
less pump replacement due to ingested thrombus than HM II 
• HM3 modular driveline may reduce pump replacements due to driveline 
damage or fatigue. 
13.5.2 
Short Term Indication 
Based on a review of recent INTERMACS and Thoratec data, it is assumed 
that the HM II will achieve a composite success rate of 85% at 6 months.  It is 
also assumed that the HM3 will have a composite success rate of 87% due to 
less pump replacements at 6 months caused by thrombus or driveline issues.  
It will take 276 total Subjects to achieve 80% power to prove the HM3 is non-
inferior to HM II when the margin of non-inferiority is -10% (=Δ in the above null 
and alternative hypotheses) using the Farrington-Manning risk difference 
approach to non-inferiority at a one-sided alpha = 0.025.  

 
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INTERMACS HM II data from 26 sites likely to participate in the HM3 IDE study 
was reviewed.  Eight hundred and twenty (820) patients were implanted with 
the HM II in 2012 at these sites and 52 (6%) received a transplant or explant 
due to myocardial recovery prior to 6 months.  In order to have sufficient data 
to evaluate the 6 month success rate, an additional 9 Subjects will be 
randomized per arm (6% of 138) to account for these early outcomes.  This 
results in 294 total Subjects.  
13.5.3 
Long Term Indication 
Based on the results from the HM II Destination Therapy IDE study, it is 
assumed that 50% of the HM II Subjects will successfully achieve the 
composite primary endpoint.  It is also assumed that the HM3 will have a 
composite success rate of 55% due to less pump replacements at 24 months 
caused by thrombus or driveline issues.  It will take HM3348 total Subjects to 
achieve 80% power to prove the HM3 is non-inferior to HM II when the margin 
of non-inferiority (=Δ in the above null and alternative hypotheses) is -10% 
using the Farrington-Manning risk difference approach to non-inferiority at a 
one-sided alpha = 0.025.  
 
INTERMACS HM II data from 26 sites likely to participate in the HM3 IDE study 
was reviewed.  Eight hundred and twenty (820) patients were implanted with 
the HM II in 2012 at these sites and 52 (6%) received a transplant or explant 
due to myocardial recovery prior to 6 months.  In order to have sufficient data 
to evaluate the 24 month success rate, an additional 9 Subjects will be 
randomized per arm (6% of 138) to account for these early outcomes.  This 
results in 366 total Subjects.  
13.6 
Early Safety Assessment 
The HM3 IDE study will include an early safety assessment in lieu of a feasibility study.  
The first 10 HM3 Subjects enrolled in the study will be included and their data analyzed 
when they have achieved 30 days of support.  A table describing the 30 days status of 
the Subjects will be prepared.  Adverse events will be presented as the percentage of 
Subjects who experience the event, the number of events and the event rate per 30 
days.  The data will be presented to the DSMB and FDA for a recommendation to 
continue the study and to expand to remaining study centers.  All Subjects included in 
the early safety assessment will continue to be followed per protocol and will be included 
in the final Short Term and Long Term analysis. 
13.7 
Analysis of Primary Endpoint 
The HM3 will be considered non-inferior to the HM II for both short and long term 
indications if the lower two-sided 95% confidence limit of the risk difference in the 
composite success between treatment arms (HM3 minus HM II) is greater than  -10% 
(“negative 10%”, where 10% is the non-inferiority Δ in the above null and alternative 
hypotheses).  Once non-inferiority is inferred, the data will be analyzed for superiority at 
a one-sided 0.025 level of significance using closed testing methods via the z-test of 
proportions using the normal approximation to the binomial distribution.  Since the short 
term and long term evaluations are two distinct endpoints, no adjustment for multiple 
comparisons is required. 

 
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13.7.1 
Primary Endpoint Stratified by Components of the Composite Endpoint 
Differences in success rates between HM3 and HM II will be performed for 
each component of the composite endpoint to evaluate if a single component is 
influencing the outcome.  Specifically, for each component, two-sided 95% 
confidence intervals of the differences and a z-test of proportions will be 
generated using the normal approximation to the binomial distribution. 
13.7.2 
Effect of Site Bias on the Primary Endpoint 
In order to determine if a few superior investigational sites are influencing the 
primary endpoint results, a comparison of results across sites will be 
performed.  Specifically, for each of the short term and long term outcomes, the 
significance of the treatment-by-site interaction effect will be assessed using 
logistic regression with the main effects for treatment and site, and with a 
treatment-by-site interaction effect.  The treatment-by-site interaction effect will 
be tested at the 0.15 level of significance.  A non-significant interaction or an 
interaction that is significant but only quantitative and not qualitative in nature 
will support the pooling of Subjects across sites for the primary analyses.  
Given that a number of sites will contribute only small numbers of Subjects, we 
will pool sites with less than 5 Subjects for the analysis.   
13.7.3 
Unblinded Interim Efficacy Analysis (Adaptive Design) 
After 50% of Subjects are treated and followed for 6 months, an interim 
unblinded analysis comparing treatments on the 6-month short term outcome 
will be carried out.  There will be no provision to stop the study at interim stage 
for overwhelming effectiveness and hence no adjustment of the significance 
level for the final analysis.  The first purpose of the interim analysis is to 
calculate the power for non-inferiority, conditioned on the interim short term 
outcome rates in each treatment and on the non-inferiority margin of 10%.  If 
conditional power is <50% or >80%, the study will continue as is; if conditional 
power is between 50-80%, the sample size will be re-estimated to maintain 
conditional power of 80% for the 6-month short term endpoint, controlling Type 
I error following the method in Wang et al10.  Any sample size increase will then 
be applied to the long term endpoint. 
13.8 
Subgroup Analysis 
Once the analyses comparing the treatment arms are complete, a series of subgroup 
analyses will be performed, assessing treatment difference within each subgroup.  Each 
subgroup will be evaluated for the primary composite endpoint, survival, adverse events, 
device malfunction, quality of life and functional status, as described above.  Subgroups 
will include but may not be limited to: 
 
• Gender: Males vs Females 
• Race: Caucasian/White vs African-American/ Black vs Other 
• Age: 18 – 59 vs 60 – 75 vs > 75 years 
• Intended Use at implant as defined by Appendix 6 
• VO2 max 
• INTERMACS Profile 
 

 
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The purpose of the subgroup analyses is not to reach a statistically significant result 
within each subgroup, but rather to assess consistency of treatment difference across 
subgroups. 
13.9 
Analysis of Survival and Subject Outcome 
Overall survival will be assessed for each of the two treatments using the Kaplan-Meier 
product-limit method.  Differences between treatments in survival distributions will be 
analyzed using a logrank test.  Subjects surviving will be censored at last known follow-
up time point.  
 
A competing outcome graph will be prepared at 6 months for short term results and 24 
months for long term results.  
13.10 Analysis of Adverse Events 
All pre-defined adverse events will be captured.  Tables will be created for HM3 and HM 
II AEs that show the by-treatment incidences of all adverse events and the by-treatment 
event rate per patient year of support.  Serious adverse events (SAEs) will be analyzed 
in a similar manner as AEs.  Differences in event rates between the treatment arms will 
be analyzed using Fisher’s Exact test or Poisson regression, as appropriate.  
13.11 Analysis of Device Malfunctions 
All suspected HM3 device malfunctions will be reported.  Thoratec will ask that all 
explanted devices be returned for analysis.  Data on device malfunctions will be 
analyzed and tables will be created that report the following: 
• Events that are confirmed by analysis of the device by Thoratec engineers 
• The component of the device involved 
• Days to the malfunction 
• Action taken in response to the malfunction 
• Reoperations due to malfunction 
• Death due to malfunction 
13.12 Analysis of Pre-Implant Data 
Tables will be created to define the study population at baseline.  Tables will include 
demographics, all laboratory assessments, all hemodynamic assessment, cardiac 
history, INTERMACS profile, and concurrent interventions (Cardiac Resynchronization 
Therapy (CRT), Automatic Internal Cardiac Defibrillator (AICD), IABP, Inotropes, etc).  
The intended use of the device at implant will also be collected, as defined by 
INTERMACS (Appendix 6).  Baseline data will be compared between treatment groups 
using unpaired t-tests or Fisher’s exact test as appropriate. 
13.13 Analysis of Implant and Discharge Data 
Time on cardiopulmonary bypass during implant surgery will be collected and reported 
as a median, quartiles and range.  All concurrent procedures carried out during implant 
surgery will be reported.  Length of Stay (LOS) will be defined as the time from implant 
to discharge.  LOS will be reported as a mean with standard deviation, median, quartiles 
and range.  The time on cardiopulmonary bypass and LOS will be compared between 
treatment groups using the Wilcoxon Rank Sum test. 

 
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13.14 Analysis of Secondary Endpoints 
Secondary endpoints will each be tested at the two-sided 0.05 level of significance.  
There will be no adjustment for multiple comparisons across the secondary endpoints.  
There will be no imputation of missing data for the secondary endpoints. 
13.14.1 Pump Hemodynamics 
The mean flow and pump index (flow/BSA) with standard deviation for the HM3 
and HM II Subjects will be plotted over time.  At each time point, treatments will 
be compared using the unpaired t-test. 
13.14.2 Laboratory values 
Mean laboratory values with standard deviations for HM3 and HM II Subjects 
will be plotted over time. At each time point, treatments will be compared using 
the unpaired t-test. 
13.14.3 Rehospitalization 
Time to rehospitalization and the reason for rehospitalization will be reported. 
Time in and out of the hospital will be reported for the HM3 and HM II Subjects.  
Treatments will be compared on time to re-hospitalization using the log-rank 
test.  Subjects not re-hospitalized will be censored at last known follow-up. 
13.14.4 Reoperations 
Time to reoperation, frequency of reoperation, and the reason for the surgery 
will be reported for HM3 and HM II Subjects.  Treatments will be compared on 
time to re-operation using the log-rank test.  Subjects not re-operated will be 
censored at last known follow-up. 
13.15 Analysis of Functional Status  
13.15.1 NYHA 
The Subjects NYHA Functional Status will be assessed by an independent 
assessor at baseline and then at 1, 3, 6, 12, 18, and 24 months.  At each visit, 
treatments will be compared on NYHA functional status and on the change 
from baseline functional status using the Wilcoxon Rank Sum test.  The Short 
Term indication will be limited to the 1, 3, and 6 month assessments.  The Long 
Term indication will include all assessments until 24 months or outcome, 
whichever occurs first.  
13.15.2 Six Minute Walk Test 
Subjects may not be able to walk due to heart failure, especially at baseline.  
Subjects unable to walk due to heart failure will receive a score of 0 meters.  
For all other reasons for missing data the score will remain missing and not be 
included in the analysis.  The Six Minute Walk test will be conducted at 
baseline and then at months 1, 3, 6, 12, 18 and 24 post implant.  Data will be 
analyzed using mixed modeling by comparing the distances walked over time 
to the baseline distance.  The Short Term indication will be limited to the 1, 3, 
and 6 month assessments.  The long term indication will include all 
assessments until 24 months or outcome, whichever occurs first.    

 
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13.16 Analysis of Quality of Life 
Quality of Life will be measured using the EuroQol (EQ-5D-5L) and the Kansas City 
Cardiomyopathy Questionnaire (KCCQ). 
13.16.1 EQ-5D-5L 
The EQ-5D-5L VAS and total score will be assessed at baseline and then at 1, 
3, 6, 12, 18, and 24 months.  Data will be analyzed using mixed modeling by 
comparing the EQ-5D-5L score at each assessment interval to the baseline 
score.  The Short Term indication will be limited to the 1, 3, and 6 month 
assessments.  The Long Term indication will include all assessments until 24 
months or outcome, whichever occurs first.  In addition, the percentage of each 
component of the EQ-5D-5L will be graphically presented over time. 
13.16.2 KCCQ 
The KCCQ score will be assessed at baseline and then at 3, 6, 12, 18, and 24 
months.  Data will be analyzed using mixed modeling by comparing the KCCQ 
score at each assessment interval to the baseline score.  The Short Term 
indication will be limited to the 3 and 6 month assessments.  The Long Term 
indication will include all assessments until 24 months or outcome, whichever 
occurs first. 
13.17 Powered secondary analysis: 
In addition to the primary outcome, the study will be powered to test if HM3 pump 
reliability is superior to HM II by analyzing the incidence of pump replacements.  
Randomization described in Section 13.4 will continue beyond the Subjects needed to 
power the primary endpoint until a sufficient sample size has been enrolled to test the 
secondary endpoint.  The null and alternative hypotheses are: 
 
Ho:  πHM3 ≥ πHM II  
HA:  πHM3 < πHM II  
where πHM3 is the HM3 pump replacement rate and πHM II is the HM II pump replacement 
rate. 
 
Based on data contained in Thoratec’s device tracking database, 7% of the HM II 
Subjects receive a pump replacement by 24 months.  If we assume that HM3 pump 
replacements will be reduced to 3% at 24 months, then 1028 Subjects  will be needed to 
prove superiority with a power of 80% and alpha = 0.05 (2-sided). 
 
Once the 366 Subjects needed for the long term indication are enrolled, Thoratec will 
continue to randomize 662 more Subjects for this secondary analysis.  Data for this 
secondary analysis is not needed for the short or long term indications, but rather will be 
used to provide additional labeling information. 
 
The Subjects will be followed for 24 months or to outcome, whichever occurs first, and 
analyzed using the Fisher’s exact test.  Treatments will also be compared on time-to-
pump replacement using the log-rank test where Subjects without a replacement are 
censored at last known follow-up.  Otherwise, there will be no imputation of missing data 
for this analysis. 

 
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14 
ADVERSE EVENTS (AE)  
14.1 
Adverse Events 
Adverse Events are any unfavorable and unintended sign (including abnormal labs), or 
symptom or disease temporally associated with the investigational product and whether 
or not related to the use of the investigational product.  Investigators are responsible for 
reporting required pre-defined AEs to the Study Sponsor in a timely manner by 
submitting AEs through the EDC, and for reporting AEs to their Institutional Review 
Board (IRB) as required. 
 
All pre-defined, anticipated AEs, including those occurring after discharge, will be 
reported and will be categorized as related to the device or not.  
 
All anticipated AE definitions can be found in Appendix 1. 
14.2 
Serious Adverse Event (SAE) 
Serious adverse events are defined as those adverse events causing death, or 
congenital abnormality or birth defect, or a life-threatening illness or injury that results in 
permanent disability, requires hospitalization, or prolongs a hospitalization, and/or 
requires intervention to prevent permanent injury or damage.  
 
SAEs must be reported to the Sponsor by submitting through the EDC as soon as 
possible but no later than three (3) calendar days from the day the study personnel 
became aware of the event or as per the investigative site’s local requirements, if the 
requirement is more stringent.  The date the site staff became aware that the event met 
the criteria of a serious adverse event must be recorded in the source document.  The 
Investigator will further report the SAE to the local IRB according to the institution’s IRB 
reporting requirements.    
 
All SAEs will be reported and will be categorized as related to the device or not. 
 
15 
UNANTICIPATED ADVERSE DEVICE EFFECTS (UADE) 
An unanticipated adverse device effect includes any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, a device, if 
that effect, problem, or death was not previously identified in nature, severity, or degree 
of incidence.  A UADE may also include any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of Subjects.  
Investigators are responsible for reporting any UADEs to Thoratec by telephone, email, 
or fax, and through the EDC as soon as the study site personnel are made aware of an 
event, but no later than three (3) calendar days of becoming aware that the event met 
the criteria for a UADE.  Thoratec will review all malfunctions and determine if they are 
UADEs.  Thoratec will report all such effects to the FDA, in accordance with regulatory 
requirements.  
 
In addition to reporting UADEs to the Study Sponsor, Investigators must report UADEs 
to their IRB as required. 

 
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16 
STUDY PROCEDURES AND ASSESSMENTS  
Participating centers will utilize their own local laboratories for protocol required 
laboratory assessments, and will be instructed to follow their institution’s requirements 
for maintenance and/or calibration of laboratory equipment.  
16.1 
Screening and Enrollment 
1. Determine if the Subject is eligible: meets all inclusion and no exclusion criteria. 
Eligibility criteria can be assessed using data obtained within 90 days of screening, 
provided the data is representative of the patient’s current clinical status.   
2. Sign written informed consent. Subjects will be considered enrolled on the day they 
sign informed consent 
3. Only Subjects who have met the eligibility criteria and signed informed consent and 
who have a scheduled implant date will be randomized through the EDC system.  
Consent and randomization should occur as close as possible to the implant date; if 
possible, within 72 hours.  
4. Demographics: age, gender, ethnicity, race 
5. Intended Use as defined by INTERMACS (Appendix 6) 
16.2 
Baseline Assessments  
The following baseline assessments will be performed within 30 days prior to implant 
(refer to Section 34, Table 2 for the Study Visit Schedule):  
 
1. Medical History, including cardiovascular history with etiology of HF and duration of 
HF 
2. Physical Exam, including height, weight and vital signs 
3. Current Medications (total daily dose): anticoagulation/anti platelet, antibiotics, and 
cardiovascular medications including ACE inhibitors, ARBs, beta blockers, statins, 
nitrates, allopurinol, aldosterone blockers, and diuretics including metolazone, 
hydrochlorothiazide and furosemide 
4. Laboratory Assessments: 
a. Hematology: hemoglobin, hematocrit, percent lymphocytes, platelet count, WBC, 
PHgb, Bleeding/Coagulation: INR, aPTT/PTT, PT 
b. Chemistry: Potassium, Blood Urea Nitrogen (BUN), creatinine, uric acid, sodium, 
eGFR (calculated), serum BNP or NT-proBNP, total protein, albumin or pre-
albumin, CRP or hs-CRP 
c. Lipids: cholesterol  
d. Liver Enzymes: LDH, AST, ALT, total bilirubin 
5. Hemodynamic Measurements 
6. Echocardiogram: LVEF, LVEDD, LVESD, AV opening, AI, MR, TR including severity 
and/or grade. 
7. Electrocardiogram (ECG): Heart Rate, QRS duration, Arrhythmias 
8. 6 Minute Walk Test (6MWT) (if Subject is able; reason must be provided if not 
performed) 
9. EQ-5D-5L 
10. Kansas City Cardiomyopathy Questionnaire (KCCQ) 
11. VO2 Max (if Subject is able; reason must be provided if not performed) 

 
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12. Functional/clinical status using the following: 
a. Modified Rankin Score (as determined by an independent assessor; defined as 
an independent, trained, and certified clinician) 
b. NYHA Classification (as determined by an independent assessor; defined as an 
advanced practice practitioner other than the treating investigator) 
c. INTERMACS Patient Profile (to be assessed immediately prior to implantation; 
refer to Appendix 2 for definitions) 
16.3 
Implant  
1. Current Medications (total daily dose): anticoagulation/anti platelet, antibiotics, and 
cardiovascular medications including ACE inhibitors, ARBs, beta blockers, statins, 
nitrates, allopurinol, aldosterone blockers, and diuretics including metolazone, 
hydrochlorothiazide and furosemide 
2. Implant data/Total CPB time/Blood Product use 
3. Pump Parameters (HM II and HM3) 
4. HM3 Pump Log files (pump period log, pump event log, controller period log, and 
controller event log) will be submitted to Thoratec 
5. Concurrent Procedures 
6. Occurrence of AEs (date of adverse event, determination of seriousness and/or 
relation to the device, resolution of the adverse event) 
7. Device Malfunctions 
8. Modified Rankin Score (as determined by an independent assessor; defined as an 
independent, trained, and certified clinician, and only if a stroke has occurred and 60 
days post-stroke) 
9. HM II Pump Log files will be submitted to Thoratec (only if a pump-related or possibly 
related AE or malfunction has occurred) 
16.4 
Post Op Day 1 (+/- 1 Day) 
1. HM3 Pump Log files (pump period log, pump event log, controller period log, and 
controller event log) will be submitted to Thoratec 
2. HM II Pump Log files will be submitted to Thoratec (only if a pump-related or possibly 
related AE or malfunction has occurred) 
3. AP chest x-ray for HM3 subjects; AP feeding tube view x-ray for HM II subjects  
4. Echocardiogram or transesophageal echocardiogram (TEE): LVEF, LVEDD, LVESD, 
AV opening, AI, MR, TR including severity and/or grade (can be perfomed on post-
operative day 0 (post-implant) +2 days) 
16.5 
1 Week Post-implant (+/- 1 Day)  
1. Current Subject Status: whether or not the Subject is ongoing on VAD support 
2. Subject Outcome: whether or not the Subject has been transplanted or explanted 
3. Current Medications (total daily dose): anticoagulation/anti platelet, antibiotics, and 
cardiovascular medications including ACE inhibitors, ARBs, beta blockers, statins, 
nitrates, allopurinol, aldosterone blockers, and diuretics including metolazone 
hydrochlorothiazide and furosemide 
4. Vital Signs 
5. Laboratory Assessments: 
a. Hematology: hemoglobin, hematocrit, percent lymphocytes, platelet count, WBC, 
PHgb, Bleeding/Coagulation: INR, aPTT/PTT, PT 

 
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b. Chemistry: Potassium, BUN, creatinine, uric acid, sodium, eGFR (calculated), 
serum BNP or NT-proBNP, total protein, albumin or pre-albumin, CRP or hs-CRP  
c. Lipids: cholesterol 
d. Liver Enzymes: LDH, AST, ALT, total bilirubin 
6. Echocardiogram: LVEF, LVEDD, LVESD, AV opening, AI, MR, TR including severity 
and/or grade. 
7. Pump Parameters (HM II and HM3) 
8. HM3 Pump Log files (pump period log, pump event log, controller period log, and 
controller event log) will be submitted to Thoratec. 
9. HM II Pump Log files will be submitted to Thoratec (only if a pump-related or possibly 
related AE or malfunction has occurred) 
10. Occurrence of AEs (date of adverse event, determination of seriousness and/or 
relation to the device, resolution of the event)   
11. Device Malfunctions 
12. Reoperations/Operative procedures  
13. Pump Replacements/Explants/Device Exchanges 
14. Driveline Management Assessment 
15. Modified Rankin Score (as determined by an independent assessor; defined as an 
independent, trained, and certified clinician, and only if a stroke has occurred and 60 
days post-stroke) 
16.6 
Discharge (-1 day) 
Subjects and his or her family member or caregiver (as applies) must be trained on the 
operation and care of their LVAS and its components, prior to discharge.  Information 
related to required Subject and caregiver training can be found in the HM II or HM3 
Instructions for Use and Patient Handbook.  Training documentation will be required to 
show compliance to the required training. 
 
1. Current Subject Status: whether or not the Subject is ongoing on VAD support 
2. Subject Outcome: whether or not the Subject has been transplanted, or explanted 
3. Current medications (total daily dose): anticoagulation/anti platelet, antibiotics, and 
cardiovascular medications including ACE inhibitors, ARBs, beta blockers, statins, 
nitrates, allopurinol, aldosterone blockers, and diuretics including metolazone, 
hydrochlorothiazide and furosemide 
4. Number of days in ICU 
5. Vital Signs 
6. Laboratory Assessments: 
a. Hematology: hemoglobin, hematocrit, percent lymphocytes, platelet count, WBC, 
PHgb, Bleeding/Coagulation: INR, aPTT/PTT, PT 
b. Chemistry: Potassium, BUN, creatinine, uric acid, sodium, eGFR (calculated), 
serum BNP or NT-proBNP, total protein, albumin or pre-albumin, CRP or hs-CRP  
c. Lipids: cholesterol 
d. Liver Enzymes: LDH, AST, ALT, total bilirubin 
7. Echocardiogram: LVEF, LVEDD, LVESD, AV opening, AI, MR, TR including severity 
and/or grade. 
8. NYHA Classification (determined by an independent assessor defined as an 
advanced practice practitioner other than the treating investigator) 
9. Pump Parameters (HM II and HM3) 

 
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10. HM3 Pump Log files (pump period log, pump event log, controller period log, and 
controller event log) will be submitted to Thoratec 
11. HM II Pump Log files will be submitted to Thoratec (only if a pump-related or possibly 
related AE or malfunction has occurred) 
12. Occurrence of AEs (date of adverse event, determination of seriousness and/or 
relation to the device, resolution of the adverse event) 
13. Device Malfunctions 
14. Reoperations/Operative procedures  
15. Pump Replacements/Explants/Device Exchanges 
16. Driveline Management Assessment 
17. Collect UB-04 Form 
18. Modified Rankin Score (as determined by an independent assessor; defined as an 
independent, trained, and certified clinician, and only if a stroke has occurred and 60 
days post-stroke) 
16.7 
Subject Follow-up Assessments  
16.7.1 
Clinic Follow-up Post-implant: 30 Days (+/- 7 days) for 1 month 
assessment, 90 Days (+/- 30 days) for 3 month assessment, and 180 days 
(+/- 30 days) for 6 month assessment  
The Subject must be seen for a clinic visit to assess the following:  
1. Current Subject Status: whether or not the Subject is ongoing on VAD 
support 
2. Subject Outcome: whether or not the Subject has been transplanted, or 
explanted  
3. Current medications (total daily dose): anticoagulation/anti platelet, 
antibiotics, and cardiovascular medications including ACE inhibitors, ARBs, 
beta blockers, statins, nitrates, allopurinol, aldosterone blockers, and 
diuretics including metolazone, hydrochlorothiazide and furosemide 
4. Vital Signs 
5. Laboratory Assessments: 
a. Hematology: hemoglobin, hematocrit, percent lymphocytes, platelet 
count, WBC, PHgb, Bleeding/Coagulation: INR, aPTT/PTT, PT 
b. Chemistry: Potassium, BUN, creatinine, uric acid, sodium, eGFR 
(calculated), serum BNP or NT-proBNP, total protein, albumin or pre-
albumin, CRP or hs-CRP  
c. Lipids: cholesterol 
d. Liver Enzymes: LDH, AST, ALT, total bilirubin 
6. Echocardiogram : LVEF, LVEDD, LVESD, AV opening, AI, MR, TR 
including severity and/or grade.  
7. Chest x-ray: PA and Lateral (30 Days and 180 Days only) 
8. NYHA Classification (determined by an independent assessor defined as 
an advanced practice practitioner other than the treating investigator) 
9. 6 Minute Walk Test (6MWT) (if Subject is able; reason must be provided if 
not performed) 
10. EQ-5D-5L 
11. Kansas City Cardiomyopathy Questionnaire (KCCQ) (90 Days and 180 
Days only) 
12. Pump Parameters (HM II and HM3) 

 
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13. Rehospitalizations 
a. If rehospitalized, collect UB-04 form 
14. HM3 Pump Log files (pump period log, pump event log, controller period 
log, and controller event log) will be submitted to Thoratec. 
15. HM II Pump Log files will be submitted to Thoratec (only if a pump-related 
or possibly related AE or malfunction has occurred) 
16. Occurrence of AEs (date of adverse event, determination of the 
seriousness and/or relation to the device, resolution of the adverse event) 
17. Device Malfunctions 
18. Reoperations/Operative procedures 
19. Pump Replacements/Explants/Device Exchanges 
20. Driveline Management Assessment 
21. Modified Rankin Score (as determined by an independent assessor; 
defined as an independent, trained, and certified clinician, and only if a 
stroke has occurred and 60 days post-stroke) 
 
16.7.2 
Clinic Follow-up Post-implant: 360 Days (+/- 30 days) for 12 month 
assessment, 540 Days (+/- 30 days) for 18 month assessment, and 720 
Days (+/- 30 days) for 24 month assessment 
The Subject must be seen for a clinic visit to assess the following:  
1. Current Subject Status: whether the Subject is ongoing on VAD support 
2. Subject Outcome: whether or not the Subject has been transplanted, or 
explanted  
3. Current medications (total daily dose): anticoagulation/anti platelet, 
antibiotics, and cardiovascular medications including ACE inhibitors, ARBs, 
beta blockers, statins, nitrates, allopurinol, aldosterone blockers, and 
diuretics including metolazone, hydrochlorothiazide and furosemide 
4. Vital Signs 
5. Laboratory Assessments: 
a. Hematology: hemoglobin, hematocrit, percent lymphocytes, platelet 
count, WBC, PHgb, Bleeding/Coagulation: INR, aPTT/PTT, PT 
b. Chemistry: Potassium, BUN, creatinine, uric acid, sodium, eGFR 
(calculated), serum BNP or NT-proBNP, total protein, albumin or pre-
albumin, CRP or hs-CRP  
c. Lipids: cholesterol 
d. Liver Enzymes: LDH, AST, ALT, total bilirubin 
6. Echocardiogram: LVEF, LVEDD, LVESD, AV opening, AI, MR, TR including 
severity and/or grade.  
7. Chest x-ray: PA and Lateral (360 Days and 720 Days only) 
8. NYHA Classification (determined by an independent assessor defined as 
an advanced practice practitioner other than the treating investigator) 
9. 6 Minute Walk Test (6MWT) (if Subject is able; reason must be provided if 
not performed) 
10. EQ-5D-5L 
11. Kansas City Cardiomypathy Questionnaire (KCCQ) 
12. Pump Parameters (HM II and HM3) 
13. Rehospitalizations 

 
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a. If rehospitalized, collect UB-04 form 
14. HM3 Pump Log files (pump period log, pump event log, controller period 
log, and controller event log) will be submitted to Thoratec. 
15. HM II Pump Log files will be submitted to Thoratec (only if a pump-related 
or possibly related AE or malfunction has occurred) 
16. Occurrence of AEs (date of the adverse event, determination of 
seriousness and/or relation to device, resolution of the adverse event) 
17. Device Malfunctions 
18. Reoperations/Operative procedures 
19. Pump Replacements/Explants/Device Exchanges  
20. Driveline Management Assessment 
21. Modified Rankin Score (as determined by an independent assessor; 
defined as an independent, trained, and certified clinician, and only if a 
stroke has occurred and 60 days post-stroke)  
 
For a detailed list of assessments and timelines, refer to the Study Visit 
Schedule in Section 34, Table 2. 
16.8 
Additional Data Collection: 
16.8.1 
Pump Log Files 
Pump log files will be submitted to Thoratec at defined time points.  Pump 
parameters and pump logs must also be submitted when any pump-related or 
possibly related AE or malfunction occurs. In addition, Thoratec may 
periodically collect pump log files, outside of the pre-specified time points 
and/or may request additional supportive hemodynamic data, if performed as 
part of the standard of care, for characterization of pump operation and system 
diagnostic purposes.  No specific pre-defined analysis will be performed on this 
data. 
16.8.2 
Chest X-Rays 
Chest x-rays will be submitted to Thoratec at defined time points.  No specific 
pre-defined analysis will be performed on this data.  
16.8.3 
Health Economics Data 
Upon hospital discharge for the initial implant hospitalization and subsequent 
re-hospitalizations, UB-04 bills, or similar detailed hospital billing data will be 
sent to Thoratec.  
 
17 
ANTICOAGULATION 
Subjects implanted with the HM3 and HM II must be properly anticoagulated to decrease 
the possibility of thromboembolism and/or pump thrombosis.  Anticoagulation guidelines 
are provided in the HM3 and HM II Instructions for Use (IFU).  
 
18 
INFECTION CONTROL GUIDELINES 
It is recommended that all investigational centers follow the Patient Care and 
Management Guidelines developed for the HM II and HM3 LVAS.  Guidelines for 
infection control and driveline management are provided in the HM II and HM3 IFU. 

 
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19 
BLOOD PRESSURE GUIDELINES 
Post-Implantation hypertension may be treated at the discretion of the attending 
physician. Any therapy that consistently maintains mean arterial blood pressure less 
than 90 mm Hg should be considered adequate.  
 
20 
POST-MORTEM EXAMINATION 
All attempts to obtain permission for a full body autopsy should be made for all Subjects 
that expire during the study.  Performance of an autopsy is to be noted on the eCRF and 
a copy of the autopsy report is to be provided to Thoratec.  The primary objective of the 
autopsy is to determine the cause of death, complications, and other relevant findings.  
In addition, special attention should be directed toward documentation of Subject-
prosthesis interaction and any HM II or HM3 LVAD associated complications. 
21 
DEVICE RETRIEVAL AND ANALYSIS 
Upon Subject death, device explantation, or device malfunction all explanted HM II and 
HM3 pumps must be retrieved and returned to Thoratec for evaluation and analysis 
within 48 hours of explant.  Devices must be returned in accordance with Thoratec 
instructions.  
 
Any system component other than the pump, (for example: controller, MPU, batteries) 
associated with any suspected device malfunction must also be returned to Thoratec for 
analysis.  
 
22 
SUBJECT WITHDRAWAL 
The Subject retains the right to withdraw from the study at any time.  Should the Subject 
elect to withdraw from the study, the reason for withdrawal must be documented in the 
CRF.  
 
Reasons for withdrawal include: 
• 
Subject chooses to withdraw 
• 
Investigator decides to withdraw Subject 
• 
Subject has pump exchanged to any device other than HM II or HM3 
• 
Subject is not implanted with device after randomization.  
o Any subject that is not immediately implanted after randomization, due to 
deterioration or improvement of their health status, will be followed to 
implant or outcome or until the cohort is fully enrolled at which time they 
will be withdrawn as follows: 
 
For the short term and long term cohorts, any subject not 
implanted or who has not achieved an outcome 30 days after the 
366th subject is enrolled will be withdrawn. 
 
For the powered secondary endpoint, any subject not implanted or 
who has not achieved an outcome 30 days after the 1028th subject 
is enrolled will be withdrawn. 

 
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• 
Subject is lost to follow-up 
o Subjects who can no longer be tracked for follow-up data collection at a 
participating MOMENTUM 3 center will be formally withdrawn from the 
study.   
 
23 
RISKS  
The HM3 LVAS is an investigational device and has not been approved by the U.S. FDA 
or any other regulatory authority.  Extensive testing has been performed on the device in 
the laboratory and in animal studies providing assurance to proceed with human use of 
the HM3 LVAS.   
 
The potential risks including anticipated adverse events and possible interactions with 
concomitant medical treatments related to use of the HM3 are expected to be similar to 
those seen with commercially available mechanical circulatory support. 
 
The recent HM II BTT Post-approval study followed 169 patients from 53 sites in the 
United States for 6 months.  The HM II DT Post-approval study followed 247 patients 
from 61 hospitals in the United States for 24 months.  If it is assumed that adverse event 
rates experienced in the HM3 study will be within the upper 99% confidence interval of 
that reported in the HM II Post-approval studies, then the expected rates for HM3 
adverse events3 would be as reported in Table 1.  In addition, the recent commercial 
data, as reported by Kirklin et al, shows that freedom from pump exchange or death due 
to pump thrombosis at 6 months is 94%11. 
 
 
Table 1 – Expected Incidence Rate of Adverse Events 
Adverse Event 
Incidence Rate at 6 
Months3 
Less than or Equal to:  
Incidence Rate at 24 
Months12 
Less than or Equal to: 
Death 
11% 
47% 
Bleeding 
56% 
62% 
Cardiac Arrhythmia 
37% 
45% 
Hemolysis 
7% 
11% 
Hepatic Dysfunction 
12% 
12% 
Driveline Infection 
26% 
22% 
Blood Infection 
28% 
26% 
Other  Localized Infection 
39% 
53% 
Stroke 
12% 
19% 
Other Neurological Dysfunction 
9% 
18% 
Pericardial Drainage 
17% 
13% 
Psychiatric Episode 
15% 
19% 
Renal Dysfunction 
17% 
25% 
Respiratory Failure 
29% 
34% 
Right Heart Failure 
23% 
25% 

 
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Adverse Event 
Incidence Rate at 6 
Months3 
Less than or Equal to:  
Incidence Rate at 24 
Months12 
Less than or Equal to: 
Venous Thromboembolism 
12% 
9% 
Device Thrombosis 
3%13 
7% 
All Other Adverse Events 
5% 
3% 
3Starling RC, Naka Y, Boyle AJ et al. Results of the Post U.S. Food and Drug Administration-Approval Study with 
a Continuous Flow Left Ventricular Assist Device as a Bridge to Heart Transplantation, J Am Coll Cardiol 2011; 
57:1890-1898 
12 Thoratec Final Post Approval Report to the FDA on the HM II Destination Therapy – INTERMACS Post 
Approval Study 
13 Thoratec Data : HM II Bridge to transplant – INTERMACS Post Approval Study  
 
 
Residual risks associated with the HeartMate 3 device are expected to be similar to 
those seen with market approved VADs.  Additional information related to the Risk 
Management process, including residual risks can be found in the Investigator’s 
Brochure. 
 
A list of potential anticipated adverse events for this study can be found in Appendix 1 of 
this protocol. 
 
24 
MITIGATIONS 
Mitigations and treatment for all adverse events should be per the current practice 
standards/standards of care as determined by the investigator. 
 
Subject risk from study participation will be mitigated by ensuring that only experienced 
LVAD personnel will be involved in the care of research Subjects.  In addition to 
providing product specific Instructions for Use (IFU), study staff will undergo product, 
implant and study training prior to initiating study activities, and all Subjects will be 
closely monitored throughout the study duration, at pre-specified time points to assess 
their clinical status. 
 
25 
BENEFITS 
Commercially available mechanical circulatory support devices have been previously 
shown to provide safe and effective hemodynamic support in advanced heart failure 
Subjects with clinical meaningful improvement in survival, quality of life and functional 
capacity when compared to optimal medical management.  It is therefore expected that 
similar benefits may be observed with the HM3 LVAS, and these benefits will outweigh 
the risks associated with the device and the required implant surgery1,2. 
 
Potential benefit of fewer HM3 device replacements will be further evaluated in this study 
as a powered secondary endpoint.  Additional potential benefits of the HM3, such as 
reduced adverse events, will also be evaluated in a descriptive manner.  
 

 
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26 
ETHICAL REQUIREMENTS 
26.1 
Informed Consent 
Informed consent must be obtained in accordance with 21 CFR Part 50.  Written 
informed consent must be obtained by the Principal Investigator or designee, before any 
study related procedures or tests are performed that would otherwise not be performed 
according to the standard of care.  If the Subject is unable to participate in the informed 
consent process, consent must be obtained from a legally authorized representative 
prior to administering any study related test or procedure.  The use of a legally 
authorized representative is only permissible if allowed by the IRB. 
 
If new information becomes available by the Sponsor that may affect a Subject’s 
participation in the study, Investigators will be required to update/revise the informed 
consent as necessary, and all Subjects will be re-consented by the site. 
 
Revisions to the informed consent will be approved by the Sponsor and the IRB prior to 
re-consenting Subjects. 
 
Each clinical site is responsible for keeping the original signed informed consent forms, 
and any updated signed informed consent forms for each Subject on file, and available 
for inspection by Thoratec.  
 
The process of obtaining Informed consent must be documented in each Subject’s 
medical record. 
26.2 
IRB Review 
Investigators will conduct the study in compliance with the Declaration of Helsinki and 
local and national regulatory requirements.  
 
Thoratec will comply with all IRB and FDA regulatory requirements. 
 
Before initiation of the study, IRB approval of the protocol and the ICF must be obtained.  
Modifications made to the ICF must be sent to Thoratec for approval, prior to submitting 
to the IRB.  Copies of the IRB submission and approval, including the approved ICF, 
must be forwarded to Thoratec prior to the enrollment of Subjects into the study.  Sites 
will submit Study progress reports as required by 21 CFR 812.150(a)(3) in writing to 
Sponsor and the IRB at least yearly.  As required by 21 CFR 812.150(a)(6), sites will 
submit to Sponsor and the IRB a final report on the Study within 3 months of completion 
or earlier termination of the study.  Copies of all submissions to and correspondence 
from the IRB (approvals and disapprovals) must be sent to Thoratec and maintained on 
file at the study site.  
26.3 
Confidentiality 
No individually identifiable/confidential Subject data collected as part of this study will be 
released beyond Thoratec.  Unique Subject study identification codes will be assigned to 
all Subjects and sites must use these unique identification codes with Subject initials on 
all study related materials.  Personal identifiable information, such as name, social 

 
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security number, and medical record number, should be redacted by the site prior to 
submission to Thoratec. 
 
27 
PROTOCOL DEVIATIONS 
This study should be conducted as described in this protocol.  All deviations from the 
protocol will be tracked and evaluated through the EDC system. 
 
For sites who demonstrate repeated deviations that may affect the safety of Subjects, 
and/or the integrity of the data, corrective measures will be instituted such as re-training. 
 
Sites must notify their IRB of protocol deviations in accordance with IRB requirements. 
 
Refer to Section 31.6 for additional information on Sponsor management of Investigator 
compliance. 
 
28 
PROTOCOL AMENDMENTS 
Significant changes to the protocol will be handled by a formal protocol amendment.  
Protocol amendments will be submitted to Investigators with instructions to submit to 
their IRB for approval.  Any study changes requested by the FDA will be provided to all 
affected IRBs. 
 
29 
DATA COLLECTION, CASE REPORT FORMS AND RECORD KEEPING 
REQUIREMENTS 
29.1 
Database and Electronic Case Report Forms (eCRFs) 
An EDC system that complies with United States regulations on electronic records and 
signatures7 (21 CFR Part 11) will be utilized for this study.  Users will have unique 
usernames and passwords, and the user list will be maintained by a Thoratec 
administrator for all study personnel.  The Investigator must ensure that the observations 
and study findings are recorded correctly and completely in the eCRFs.  Each eCRF 
requiring a signature must be signed and dated by the authorized personnel.  
 
Data being submitted through the course of the clinical study will be reviewed by the 
Sponsor for accuracy and completion.  Database cleaning and the process for issuing 
and/or resolving queries will be documented in the Sponsors study specific data 
management plan. 
29.2 
Device Accountability Records 
The Thoratec HeartMate 3 LVAS is an investigational device.  All investigational devices 
must be stored in a location that is accessible only by authorized study personnel.  The 
Sponsor and investigator must maintain accurate Device Accountability records 
indicating the date of shipment, receipt of product, date of use and assignment to study 
Subject, and final disposition (return) of the devices.  
 

 
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Traceability of investigational devices will be maintained by the Sponsor through the use 
of unique serial and/or lot numbers.  
 
All unused investigational components must be returned to the Sponsor, as directed.  
 
NOTE: Investigational devices should only be used on Subjects who are enrolled 
in the study and randomized to the HM3 arm. 
  
29.3 
Source Documentation 
Original documentation supporting the data recorded on the eCRFs must be maintained, 
and include clinical charts, medical records, laboratory reports, physician referral or 
consultation letters, X-ray reports, etc.  Adverse events which are managed at a health 
care facility other than the study site must be reported on an eCRF and every attempt 
must be made to obtain source documentation from that facility. 
 
During monitoring visits, source documents will be reviewed to ensure accuracy and 
validity of data recorded on the eCRFs.  Source document verification will be performed 
by Thoratec, or its designee, with due regard to Subject confidentiality.  
29.4 
Maintenance of Study Documentation 
The following documents should be maintained by the study site, and copies of site 
specific documents sent to Thoratec: 
 
• 
Copy of the Study Protocol 
• 
IRB Approval(s)  
• 
Pertinent IRB Correspondence 
• 
IRB approved Informed Consent Form(s) 
• 
IRB Membership Roster(s) or Federal wide Assurance (FWA) number  
• 
Financial Disclosure(s) 
• 
Investigator’s Agreement(s) 
• 
Curriculum Vitae(s) 
• 
Study Staff Signature and Delegation of Responsibilities Log 
• 
Laboratory Certification(s) and Normals 
• 
Source documentation (such as Subject clinic charts, medical records, laboratory 
records) 
• 
Clinical Study Agreement (CSA) 
• 
Confidentiality Agreement, if separate from CSA 
• 
Thoratec Correspondence  
• 
Annual/Semi- annual Regulatory Reports 
• 
Documentation of Training  
• 
Monitoring Visit Log 
• 
Device Accountability 
• 
Investigator Brochure 
• 
Instructions for Use (IFU) 
• 
Patient Manual 

 
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29.5 
Regulatory Reporting Requirements 
29.5.1 
Site Reporting 
Sites will submit Study progress reports as required by 21 CFR 812.150(a)(3) 
in writing to the Sponsor and the IRB at least yearly.  As required by 21 CFR 
812.150(a)(6), sites will submit to Sponsor and the IRB a final report on the 
study within 3 months of completion or earlier termination of the study.  
 
29.5.2 
Sponsor Reporting 
Thoratec Corporation will submit Study progress reports as required by 21 CFR 
812.150(b)(5) to all reviewing IRBs at least yearly.  Thoratec will submit a final 
report to FDA and all reviewing IRBs and participating investigators within six 
months after completion or termination, as required by 21 CFR 812.150(b)(7). 
Thoratec will comply with all other reporting requirements as outlined in CFR 
812.150(b). 
29.6 
Retention of Records 
In accordance with 21 CFR Part 812.40 the site will retain the Study records in 
accordance with and for the period required by applicable laws, and at least two years 
after the date of the latter: (1) the date on which the Study is terminated or completed, or 
(2) the date that the records are no longer required for purposes of supporting a 
marketing application.  This includes a copy of the protocol, the device labeling, case 
report forms, medical records, original test result reports, all study related 
correspondence, a record of written informed consent, and any other documents 
pertaining to the conduct of this study.   
 
In addition, any and all records maintained in electronic form by Site, Investigator, or 
Subinvestigators shall be maintained at all times in compliance with applicable laws, 
including 21 CFR Part 117. 
 
The investigator must not dispose of any records relevant to this study without either (1) 
written permission from Thoratec or (2) providing an opportunity for Thoratec to collect 
such records.  The investigator shall take responsibility for maintaining adequate and 
accurate electronic or hard copy source documents of all observations and data 
generated during this study.  Such documentation is subject to inspection by Thoratec 
and regulatory authorities. 
29.7 
Laboratory Accreditation and Normal Values 
Before initiation of the study, appropriate accreditation for all laboratories to be used in 
the study will be requested by Thoratec.  Throughout the study, the Investigator shall 
provide Thoratec documentation of all renewals of accreditation.  The range of values 
considered normal for the laboratory tests being performed for the study must be 
provided to Thoratec in order to allow the data to be pooled.  
 
30 
INSURANCE 
Thoratec will obtain insurance to cover potential injury to Subjects in accordance with 
national requirements. 

 
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31 
QUALITY CONTROL 
31.1 
Independent Monitoring Boards  
31.1.1 
Data Safety Monitoring Board (DSMB): 
To meet the study's ethical responsibility to its Subjects and to protect the 
safety of the Subjects, an independent DSMB, comprised of experts in the field, 
will monitor the study.  Pre-specified guidelines related to governance of the 
DSMB, data review, early stopping rules for key adverse events, and 
recommendations by the committee to stop the study, or continue the study 
with or without modification (s), will be outlined in a DSMB charter. After the 
10th HM3 subject reaches 30-day follow-up, all safety data will be provided to 
the DSMB and a report provided to the FDA. A second formal safety report will 
be provided to the DSMB and FDA after the 10th HM3 subject reaches 6 
months.   
 
31.1.2 
Clinical Events Committee (CEC): 
An independent CEC comprised of experienced experts in the field, will review 
and adjudicate adverse events to provide consistency in the categorization of 
adverse events.  Event adjudication will be performed in accordance with the 
study’s pre-specified adverse event definitions and in accordance with the CEC 
charter. 
31.2 
Investigator Selection 
Prior to the initiation of the study, investigators will be selected based on their 
qualifications and experience (qualified by education and training) to ensure Subject 
safety and adherence to the protocol. 
31.3 
Site Selection 
Prior to the initiation of the study, study sites will be selected based on experience with 
the care of LVAD Subjects, on adequate access to the intended population, adequate 
resources to conduct the study in accordance with the protocol, and adequate 
facilities/equipment to perform required tests and procedures as described in the 
protocol. 
 
The Sponsor will maintain an updated list of principal investigators, investigational sites 
and/or institutions separately from the protocol.  The list will be included in clinical 
investigation reports as required by 21 CFR part 812.150. 
31.4 
Site Staff Training 
Only trained personnel can perform study related procedures.  All clinical personnel 
(principal investigators, co-investigators, study coordinators) must be thoroughly familiar 
with the function, care and maintenance of the HM3 LVAS.  These individuals will 
undergo training by Thoratec or designee, and documentation of that training will be 
maintained.  The Thoratec HM3 LVAS Instructions for Use will be provided to assist the 
healthcare team on the proper care and operation of the device. 

 
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31.5 
Monitoring 
Thoratec Corporation is responsible for monitoring the study. Thoratec will monitor in 
accordance with FDA Guidance document OMB 0910-0733, Oversight of Clinical 
Investigations - A Risk-Based Approach to Monitoring.  After the study has been 
initiated, Thoratec or its designee will perform periodic monitoring visits to assess study 
progress, perform device accountability, assess the adequacy of records, and to ensure 
adherence to the study protocol.   
 
A summary of the monitoring visit, including documentation of completed previous action 
items and/or new or outstanding action items, and/or significant findings will be provided 
to the Investigator. 
 
In addition to periodic on-site monitoring visits, Thoratec will perform remote monitoring 
to ensure data is submitted in a timely manner.  Ongoing communication with 
investigators and study staff will be performed through written correspondence and 
telephone conversations.   
 
Details related to site monitoring will be documented in the Sponsor’s study specific 
monitoring plan. 
 
31.5.1 
Pre-Investigational (Initiation) Visit: 
Thoratec or its designee will be responsible for determining and documenting 
that each investigator clearly understands and accepts the responsibilities and 
obligations of conducting a clinical study.  If the site attends a study-specific 
investigator meeting, the investigator meeting may take the place of an on-site 
initiation visit.  Prior to enrollment, the Sponsor or its designee will ensure that 
the investigator: 
 
• 
Understands the requirements for device accountability  
• 
Understands the nature of the clinical protocol 
• 
Understands reporting obligations 
• 
Understands and accepts the obligations to obtain informed consent  
• 
Understands and accepts the obligation to obtain IRB review and approval 
of the clinical investigation before it is initiated and to ensure continuing 
review of the study by the IRB, and to keep the Sponsor informed of all IRB 
actions concerning the study 
• 
Has adequate facilities and access to an adequate number of suitable 
Subjects to conduct the investigation 
31.5.2 
Periodic Monitoring Visits: 
Monitoring visits will be conducted in accordance with applicable regulations, 
the study specific monitoring plan, and Thoratec’s procedures.  This study will 
be monitored to ensure the following: 
• 
Facilities continue to be adequate and acceptable 
• 
The protocol is being properly followed 
• 
The IRB has approved or been notified of any protocol changes per IRB 
requirements 

 
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• 
Accurate, complete and current records are being maintained, and the 
information recorded and submitted to the Sponsor is representative of the 
Subject’s record and other supporting documentation 
• 
Accurate, complete and timely adverse event reports are being submitted to 
the Sponsor 
• 
Informed consent has been obtained 
• 
The reason for a Subject’s withdrawal from the study has been documented 
• 
Required reports are being submitted to the IRB and Sponsor  
• 
The appropriate staff is carrying out study activities 
 
The Investigator or designee must, upon request, provide to the sponsor the 
necessary study records for a thorough review of the study’s progress.  These 
records include, but are not limited to, access to investigational device storage 
and accountability records, case report forms and original source documents 
and records such as hospital and clinic charts, consent forms, and operative 
reports.  
31.5.3 
Study Closeout Activities:  
The following study closeout activities will be performed prior to completion of 
the study in accordance with Thoratec’s procedures:  
• 
Ensure that all required eCRFs have been completed/submitted 
• 
Ensure final disposition of investigational devices 
• 
Remind the investigator of the obligation to retain the records in accordance 
with FDA and Sponsor requirements, and prepare a final report for the 
Sponsor and IRB 
31.6 
Investigator and/or Study Site Termination/Suspension 
A pattern of non-compliance and continued deviations will result in Thoratec instituting a 
formal written request for corrective action.  If there is an inadequate response from the 
Investigator, Thoratec may cease shipment of the investigational device and notify the 
IRB of this action. 
 
Thoratec may consider terminating or suspending an investigator and/or study site in the 
following cases: 
• 
Confirmed serious or repeated deviations and general non-compliance to the 
protocol 
• 
Unacceptable critical changes in personnel, administrative, or scientific standards 
• 
Unacceptable risk to Subject safety is confirmed 
In such cases, Thoratec will notify the appropriate regulatory authority, and/or other 
participating centers as required by local and national regulations. 
31.7 
Early Study Termination 
Thoratec reserves the right to discontinue the study prior to fulfillment of the intended 
number of Subjects.  Thoratec intends to exercise this right only for valid scientific or 
administrative reasons.  After such a decision, all unused investigational products must 
be returned to Thoratec and all collected data must be entered into EDC. 
 

 
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The study could be prematurely discontinued in the following cases: 
• 
New findings about the investigational product(s) that changes the risk/benefit ratio 
where the risk to study Subjects is unacceptable. 
• 
For any other valid scientific or administrative reason(s) as determined by Thoratec. 
 
32 
EMERGENCY CONTACTS 
Thoratec Clinical Affairs personnel are available 24 hours a day via the protocol pager to 
provide assistance with all protocol-related questions and/or for safety reporting.  The 
number for the protocol pager is 1-877-479-0299. 
 
The Thoratec HeartLine is available 24 hours a day for all device-related emergencies. 
The number for the HeartLine is 1-800-456-1477. 
33 
PUBLICATION POLICY 
The first publication or presentation of Clinical Study Results shall be made as a joint, 
multi-center publication/presentation of the Study results with the investigators and 
institutions from all appropriate sites contributing data, analyses and comments.  All 
publications will be reviewed by the study investigators and the Sponsor, and in 
accordance with the site specific Clinical Study Agreement (CSA).

 
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34 
MOMENTUM 3 IDE STUDY VISIT SCHEDULE 
 
Table 2 – Schedule of Events for Randomized Subjects 
 
Screening1 Baseline1 Implant Post-Op 
Day 1 
(+/- 1 day) 
1 Week 
Post 
Implant 
(+/- 1 day) 
Discharge 
(-1 day) 
30 Days 
Post 
Implant 
(+/- 7 
days) 
90 Days 
Post 
Implant 
(+/- 30 
days) 
180 Days 
Post 
Implant 
(+/- 30 
days) 
360 Days 
Post 
Implant 
(+/- 30 
days) 
540 Days 
Post 
Implant 
(+/- 30 
days) 
720 Days 
Post 
Implant 
(+/- 30 
days) 
As 
Occurs 
Inclusion/ Exclusion 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Enrollment / 
Randomization 
X17 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Intended Use11 
X 
 
 
 
 
 
 
 
 
 
 
 
 
General and Cardiac 
Medical History 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Current Medications / 
Cardiovascular 
Medications9 
 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Physical Exam 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Vital Signs2 
 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Hemodynamic 
Measurements3 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Laboratory 
Assessments 
 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Echocardiogram 
 
X 
 
X15 
X 
X 
X 
X 
X 
X 
X 
X 
 
ECG 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Chest X-ray 13 
(PA and Lateral) 
 
 
 
X16 
 
 
X 
 
X 
X 
 
X 
 
Modified Rankin 
Score19  
 
X 
X6 
 
X6 
X6 
X6 
X6 
X6 
X6 
X6 
X6 
X6 
NYHA Classification 5 
 
X 
 
 
 
X 
X 
X 
X 
X 
X 
X 
 
INTERMACS Profile18  
 
X 
 
 
 
 
 
 
 
 
 
 
 
6 Minute Walk Test 
 
X 
 
 
 
 
X 
X 
X 
X 
X 
X 
 
EQ-5D-5L 
 
X 
 
 
 
 
X 
X 
X 
X 
X 
X 
 
KCCQ 
 
X 
 
 
 
 
 
X 
X 
X 
X 
X 
 

 
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Screening1 Baseline1 Implant Post-Op 
Day 1 
(+/- 1 day) 
1 Week 
Post 
Implant 
(+/- 1 day) 
Discharge 
(-1 day) 
30 Days 
Post 
Implant 
(+/- 7 
days) 
90 Days 
Post 
Implant 
(+/- 30 
days) 
180 Days 
Post 
Implant 
(+/- 30 
days) 
360 Days 
Post 
Implant 
(+/- 30 
days) 
540 Days 
Post 
Implant 
(+/- 30 
days) 
720 Days 
Post 
Implant 
(+/- 30 
days) 
As 
Occurs 
VO2  Max10 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Implant Data/CPB 
Time/Blood Products 
 
 
X 
 
 
 
 
 
 
 
 
 
X 
HM II and HM3 Pump 
Parameters7 
 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X14 
Concurrent  
Procedures at Pump 
Implant 
 
 
X 
 
 
 
 
 
 
 
 
 
X 
Subject Status 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Subject Outcome 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ICU Time 
 
 
 
 
 
X 
 
 
 
 
 
 
 
Rehospitalizations 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
HM3 Pump Log Files8 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 X14 
HM II Pump Log Files 
 
 
 
 
 
 
 
 
 
 
 
 
X14 
Adverse Events 4 
 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Device Malfunctions4 
 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Operative 
Procedures4 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Pump Replacements / 
Explants / Exchanges 
4 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Driveline 
Management 
Assessment 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Collection of UB-04 
Form 
 
 
 
 
 
X 
 
 
 
 
 
 
X12 
Autopsy 
 
 
 
 
 
 
 
 
 
 
 
 
X 
1 Screening and Baseline assessments can be conducted as one visit or separate visits. 
2 Vital Signs include: height (only at baseline), weight, temperature, respiratory rate, heart rate, blood pressure and mean arterial pressure. 
3 Hemodynamic Measurements include: Pulmonary Capillary Wedge Pressure, Pulmonary Arterial Systolic Pressure, Pulmonary Arterial Diastolic Pressure, Pulmonary Arterial Mean 
Pressure, Central Venous Pressure, Cardiac Index, Cardiac Output, Pulmonary Vascular Resistance, Right Atrial pressure, and Left Atrial pressure (LAP only if available). 
4 Post Implant or during implant procedure. 
5 Must be performed by an independent assessor. 
6 Required only if a stroke has occurred and 60 days post-stroke. 

 
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7 HM II and HM3 Pump Parameters include: Pump Flow, Pump Speed, Pulsatility Index and Pump Power. 
8 Pump Log Files include: Pump Period Log, Pump Event Log, Controller Period Log, and Controller Event Log. 
9 If Subject is on inotropes at the time of screening/baseline, list how long the Subject has been on inotropes. 
10If Subject is able. If Subject is unable to perform, must provide reason this was not done. 
11 At the time of implant and as defined by INTERMACS; refer to Appendix 6. 
12 To be collected any time subject is rehospitalized. 
13 Images to be submitted to Thoratec. 
14 In addition to defined scheduled collection of pump parameters and pump logs, they must also be submitted when any pump-related or possibly related AE or malfunction occurs. 
15Post-operative TEE is also acceptable; can be performed POD 0 (post-implant) + 2 days 
16AP view for HM3 subjects; feeding tube view for HM II subjects 
17Randomization should occur as close as possible to the implant date; if possible, within 72 hours. 
18INTERMACS profile to be assessed immediately prior to implantation 
19Must be performed by an independent assessor; defined as an independent, trained, and certified clinician 

 
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35 
REFERENCES 
1. Miller LW, Pagani FD, Russell SD, et al. Use of a continuous-flow device in patients 
awaiting heart transplantation. N Engl J Med 2007; 357: 885-896 
 
2. Slaughter, MS, Rogers JG, Milano CA et al.  Advanced Heart Failure Treated with 
Continuous-Flow Left Ventricular Assist Device N Engl J Med 2009; 361: 2241-2251 
 
3. Starling RC, Naka Y, Boyle AJ et al. Results of the Post U.S. Food and Drug 
Administration-Approval Study with a Continuous Flow Left Ventricular Assist Device 
as a Bridge to Heart Transplantation, J Am Coll Cardiol 2011; 57:1890-1898. 
 
4. Active Implantable Medical Device Directive (AIMDD) 90/385/EEC. (June 20, 1990) 
 
5. EN ISO 14155: 2011 - Clinical investigation of medical devices for human subjects – 
Part 1: General requirements   
 
6. FDA. United States Code of Federal Regulations, Electronic Records: Electronic 
Signatures; Final Rule. Source: 21 CFR Part 11 (April 1, 2013). 
 
7. Guidelines on Clinical Investigation: a Guide for Manufacturers and Notified Bodies, 
MEDDEV 2.7/4 
 
8. Organisation for Economic Co-operation and Development (OECD) Principles of 
Good Laboratory Practice (GLP) in 1997 
 
9. Rogers JG, Aaronson KD, Boyle AJ et al. Continuous Flow Left Ventricular Assist 
Device Improves Functional Capacity and Quality of Life of Advanced Heart Failure 
Patients. J Am Coll Cardiol. 2010; 55:1826-34. 
 
10. Wang C, Keller DS, Lan KKG.  Sample size re-estimation for binary data via 
conditional power.  Joint Statistical Meetings – Biopharmaceutical Section. 2002 
 
11. Kirklin JK, Naftel DC, Kormos RL et al. INTERMACS Analysis of Pump Thrombosis 
in the Heartmate II Left Ventricular Assist Device. J. Heart Lung Transplant. 2014; 
33:12-22. 
 
12. Thoratec Final Post Approval Report to the FDA on the HM II Destination Therapy – 
INTERMACS Post Approval Study  
 
13. Thoratec Data: HM II Bridge to Transplant – INTERMACS Post Approval Study 
 
14. World Medical Association Declaration of Helsinki: Ethical Principles for Medical 
Research Involving Human Subjects. 2013 
 

 
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APPENDIX 1: ANTICIPATED ADVERSE EVENT DEFINITIONS  
 

 
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Bleeding 
An episode of SUSPECTED INTERNAL OR EXTERNAL BLEEDING that results in one or more 
of the following: 
a. Death, 
b. Reoperation, 
c. Hospitalization, 
d. Transfusion of red blood cells as follows: 
 If transfusion is selected, then apply the following rules:  
During first 7 days Post-implant 
• 
≥ 50 kg: ≥ 4U packed red blood cells (PRBC) within any 24 hour period during first 7 
days post-implant. 
• 
<50 kg: ≥20 cc/kg packed red blood cells (PRBC) within any 24 hour period during 
the first 7 days post-implant 
After 7 days Post-implant* 
• 
Any transfusion of packed red blood cells (PRBC) after 7 days following implant with 
the investigator recording the number of units given.  (Record number of units given 
per 24 hour period). 
Note:  Hemorrhagic stroke is considered a neurological event and not as a separate bleeding 
event. 
*Any transfusion of ≥ 2U packed red blood cells (PRBC) after 7 days following implant will be 
considered a serious bleed 
 
Cardiac Arrhythmias 
Any documented arrhythmia that results in clinical compromise (e.g., diminished VAD flow, 
oliguria, pre-syncope or syncope) that requires hospitalization or occurs during a hospital stay.  
Cardiac arrhythmias are classified as 1 of 2 types: 
1) Sustained ventricular arrhythmia requiring defibrillation or cardioversion. 
2) Sustained supraventricular arrhythmia requiring drug treatment or cardioversion. 
 
Pericardial Fluid Collection 
Accumulation of fluid or clot in the pericardial space that requires surgical intervention or 
percutaneous catheter drainage.  This event will be subdivided into those with clinical signs of 
tamponade (e.g. increased central venous pressure and decreased cardiac/VAD output) and 
those without signs of tamponade. 
 
Device Malfunctions 
A Device Malfunction occurs when any component of the MCSD system ceased to operate to its 
designated performance specifications or otherwise fails to perform as intended. Performance 
specifications include all claims made in the Instructions for Use. 
 
Internal Component Malfunction: Malfunction of any device system component that is 
implanted within the patient. A malfunction to these components may require further surgery 
to repair or replace.  
 
External Component Malfunction: Malfunction of a device system component that is used 
external to the patient and can be replaced or repaired without the need for further surgery. 

 
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Device Thrombosis 
Device thrombosis is an event in which the pump or its conduits contain a thrombus that results 
in or could potentially induce circulatory failure. Suspected device thrombus is an event in which 
clinical or MCSD parameters suggest thrombus on the blood contacting components of the 
pump, cannulae, or grafts. Signs and symptoms should include at least 2 of the 3 following 
criteria: 
a. Presence of hemolysis 
b. Worsening heart failure or inability to decompress the left ventricle 
c. Abnormal pump parameters 
 
Suspected pump thrombus should be accompanied by 1 or more of the following events or 
interventions: 
i. Treatment with intravenous anticoagulation (e.g., heparin), intravenous thrombolytics 
(e.g., tPA), or intravenous antiplatelet therapy (e.g., eptifibatide, tirofiban) 
ii. Pump replacement 
iii. Pump explantation 
iv. Urgent transplantation (UNOS status 1A) 
v. Stroke 
vi. Arterial non-CNS thromboembolism 
vii. Death 
 
Confirmed device thrombus is an event in which thrombus is confirmed by Thoratec returned 
product analysis to be found within the blood contacting surfaces of device inflow cannula or 
outflow conduit or grafts. This can also be reported via direct visual inspection or by 
incontrovertible contrast radiographic evidence or by the absence of an appropriate Doppler 
flow signal that results in or could potentially induce circulatory failure or result in 
thromboembolism. 
 
Hemolysis* 
A plasma-free hemoglobin value that is greater than 40 mg/dl, concomitant with a rise in serum 
LDH above three times the upper limit of normal, in association with clinical signs associated 
with hemolysis (e.g., anemia, low hematocrit, hyperbilirubinemia) occurring after the first 72 
hours post-implant.  
*Hemolysis in the presence of worsening heart failure or inability to decompress the left ventricle 
or abnormal pump parameters should be reported as suspected device thrombosis, not as 
hemolysis  
 
Hepatic Dysfunction 
An increase in any two of the following hepatic laboratory values (total bilirubin, aspartate 
aminotransferase/AST and alanine aminotransferease/ALT) to a level greater than three times 
the upper limit of normal for the hospital, beyond 14 days post-implant (or if hepatic dysfunction 
is the primary cause of death).   
 
Hypertension 
Blood pressure elevation of a mean arterial pressure greater than 110 mm Hg, despite anti-
hypertensive therapy.    

 
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Major Infection 
A clinical infection accompanied by pain, fever, drainage and/or leukocytosis that is treated by 
anti-microbial agents (non-prophylactic).  A positive culture from the infected site or organ 
should be present unless strong clinical evidence indicates the need for treatment despite 
negative cultures.  The general categories of infection are listed below: 
Localized Non-Device Infection 
Infection localized to any organ system or region (e.g. mediastinitis) without evidence of 
systemic involvement (see sepsis definition), ascertained by standard clinical methods and 
either associated with evidence of bacterial, viral, fungal or protozoal infection, and/or requiring 
empirical treatment.  
Percutaneous Site and/or Pocket Infection 
A positive culture from the skin and/or tissue surrounding the drive line or from the tissue 
surrounding the external housing of a pump implanted within the body, coupled with the need to 
treat with antimicrobial therapy, when there is clinical evidence of infection such as pain, fever, 
drainage, or leukocytosis. 
Internal Pump Component, Inflow or Outflow Tract Infection 
Infection of blood-contacting surfaces of the LVAD documented by positive site culture. 
Sepsis 
Evidence of systemic involvement by infection, manifested by positive blood cultures and/or 
hypotension. 
 
Myocardial Infarction 
Two categories of myocardial infarction will be identified: 
 
Peri-Operative Myocardial Infarction 
The clinical suspicion of myocardial infarction together with CK-MB or Troponin > 10 times the 
local hospital upper limits of normal, found within 7 days following VAD implant together with 
ECG findings consistent with acute myocardial infarction.  (This definition uses the higher 
suggested limit for serum markers due to apical coring at the time of VAD placement, and does 
not use wall motion changes because the apical sewing ring inherently creates new wall motion 
abnormalities.)  
 
Non-Perioperative Myocardial Infarction 
The presence at > 7 days post-implant of two of the following three criteria:   
 
a) Chest pain which is characteristic of myocardial ischemia,  
b) ECG with a pattern or changes consistent with a myocardial infarction, and  
c) Troponin or CK (measured by standard clinical pathology/laboratory medicine methods) 
greater than the normal range for the local hospital with positive MB fraction (≥ 3% total CK).  
This should be accompanied by a new regional LV or RV wall motion abnormality on a 
myocardial imaging study. 
 
Neurologic Dysfunction 
Any new, temporary or permanent, focal or global neurological deficit, ascertained by a standard 
neurological history and examination administered by a neurologist or other qualified physician 
and documented with appropriate diagnostic tests and consultation note; or an abnormality 

 
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identified by surveillance neuroimaging. The examining physician will classify the event as 
defined below:  
 
a. Transient ischemic attack*, defined as an acute transient neurological deficit conforming 
anatomically to arterial distribution cerebral ischemia, which resolves in < 24 hours and 
is associated with no infarction on brain imaging (head CT performed >24 hours after 
symptom onset; or MRI) 
b. Ischemic Stroke*: a new acute neurologic deficit of any duration associated with acute 
infarction on imaging corresponding anatomically to the clinical deficit, or a clinically 
covert ischemic stroke seen by surveillance imaging, without clinical findings of stroke or 
at the time of event recognition. 
c. Hemorrhagic Stroke*: a new acute neurologic deficit attributable to intracranial 
hemorrhage (ICH), or a clinically covert ICH seen by surveillance imaging, without 
clinical findings of ICH at the time of event recognition. 
d. Encephalopathy: Acute new encephalopathy** due to hypoxic-ischemic injury (HIE), or 
other causes, manifest as clinically evident signs or symptoms, or subclinical 
electrographic seizures found by complete neurological diagnostic evaluation to be 
attributable to acute global or focal hypoxic, or ischemic brain injury not meeting one of 
ischemic stroke or ICH events as defined above. 
e. Seizure of any kind 
f. 
 Other neurological event (non-CNS event): examples include neuro muscular 
dysfunction or critical care neuropathy 
 
*Modified Rankin Score will be used to classify the severity of all strokes 
**Acute encephalopathy is a sign or symptom of some underlying cerebral disorder, and is 
manifest as depressed consciousness with or without any associated new global or multifocal 
neurologic deficits in cranial nerve, motor, sensory, reflexes and cerebellar function. 
 
Psychiatric Episode 
Disturbance in thinking, emotion or behavior that causes substantial impairment in functioning or 
marked subjective distress requiring intervention.  Intervention is the addition of new psychiatric 
medication or hospitalization.  Suicide is included in this definition. 
 
Renal Dysfunction 
Two categories of renal dysfunction will be identified: 
 
Acute Renal Dysfunction 
Abnormal kidney function requiring dialysis (including hemofiltration) in Subjects who did not 
require this procedure prior to implant, or a rise in serum creatinine of greater than 3 times 
baseline or greater than 5 mg/dL sustained for over 48 hours. 
 
Chronic Renal Dysfunction 
An increase in serum creatinine of 2 mg/dl or greater above baseline, or requirement for 
hemodialysis sustained for at least 90 days. 

 
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Respiratory Failure 
Impairment of respiratory function requiring reintubation, tracheostomy or (the inability to 
discontinue ventilatory support within six days (144 hours) post-VAD implant.  This excludes 
intubation for reoperation or temporary intubation for diagnostic or therapeutic procedures. 
 
Right Heart Failure 
Symptoms and signs of persistent right ventricular dysfunction requiring RVAD implantation, or 
requiring inhaled nitric oxide or inotropic therapy for a duration of more than 1 week at any time 
after LVAD implantation. 
 
Arterial Non-CNS Thromboembolism 
An acute systemic arterial perfusion deficit in any non-cerebrovascular organ system due to 
thromboembolism confirmed by one or more of the following:  
 
1) Standard clinical and laboratory testing 
2) Operative findings 
3) Autopsy findings 
 
This definition excludes neurological events. 
 
Venous Thromboembolism Event 
Evidence of venous thromboembolic event (e.g. deep vein thrombosis, pulmonary embolism) by 
standard clinical and laboratory testing.  
 
Wound Dehiscence 
Disruption of the exposed surfaces of a surgical incision, excluding infectious etiology, and 
requiring surgical repair. 
 
Other 
An event that causes clinically relevant changes in the Subject’s health (e.g. cancer). 
 

 
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APPENDIX 2: INTERMACS PROFILE/CLASSIFICATION 
 

 
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INTERMACS 
Profile* 
Definition 
1 
Critical cardiogenic shock describes a patient who is “crashing and burning”, in 
which a patient has life-threatening hypotension and rapidly escalating inotropic 
pressor support, with critical organ hypoperfusion often confirmed by worsening 
acidosis and lactate levels.  
2 
Progressive decline describes a patient who has been demonstrated “dependent” 
on inotropic support but nonetheless shows signs of continuing deterioration in 
nutrition, renal function, fluid retention, or other major status indicator. Patient 
profile 2 can also describe a patient with refractory volume overload, perhaps with 
evidence of impaired perfusion, in whom inotropic infusions cannot be maintained 
due to tachyarrhythmias, clinical ischemia, or other intolerance.  
3 
Stable but inotrope dependent describes a patient who is clinically stable on mild-
moderate doses of intravenous inotropes (or has a temporary circulatory support 
device) after repeated documentation of failure to wean without symptomatic 
hypotension, worsening symptoms, or progressive organ dysfunction (usually 
renal). It is critical to monitor nutrition, renal function, fluid balance, and overall 
status carefully in order to distinguish between a patient who is truly stable at 
Patient Profile 3 and a patient who has unappreciated decline rendering this 
person a Patient Profile 2. This patient may be either at home or in the hospital.  
4 
Resting symptoms describes a patient who is at home on oral therapy but 
frequently has symptoms of congestion at rest or with ADL. He or she may have 
orthopnea, shortness of breath during ADL such as dressing or bathing, 
gastrointestinal symptoms (abdominal discomfort, nausea, poor appetite), 
disabling ascites or severe lower extremity edema. This patient should be carefully 
considered for more intensive management and surveillance programs, by which 
some may be recognized to have poor compliance that would compromise 
outcomes with any therapy.  
5 
Exertion Intolerant describes a patient who is comfortable at rest but unable to 
engage in any activity, living predominantly within the house or housebound. This 
patient has no congestive symptoms, but may have chronically elevated volume 
status, frequently with renal dysfunction, and may be characterized as exercise 
intolerant.  
6 
Exertion Limited also describes a patient who is comfortable at rest without 
evidence of fluid overload, but who is able to do some mild activity. Activities of 
daily living are comfortable and minor activities outside the home such as visiting 
friends or going to a restaurant can be performed, but fatigue results within a few 
minutes of any meaningful physical exertion. This patient has occasional episodes 
of worsening symptoms and is likely to have had a hospitalization for heart failure 
within the past year.  
7 
Advanced NYHA Class 3 describes a patient who is clinically stable with a 
reasonable level of comfortable activity, despite history of previous 
decompensation that is not recent. This patient is usually able to walk more than a 
block. Any decompensation requiring intravenous diuretics or hospitalization within 
the previous month should make this person a Patient Profile 6 or lower.   
* Stevenson, L.W. et al. INTERMACS Profiles of Advanced Heart Failure: The Current Picture, J Heart Lung 
Transplant. 2009 28(6): 535-541 
 
 

 
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APPENDIX 3: NYHA CLASSIFICATION 
 

 
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Classification 
Definition 
I 
Cardiac disease without resulting limitations of physical activity. 
Ordinary physical activity does not cause undue fatigue, palpitations, 
dyspnea or anginal pain. 
II 
Cardiac disease resulting in slight limitation of physical activity. 
Subjects are comfortable at rest. Ordinary physical activity results in 
fatigue, palpitation, dyspnea or anginal pain. 
IIIA 
Cardiac disease resulting in marked limitations of physical activity. 
Subjects are comfortable at rest. Less than ordinary physical activity 
causes fatigue, palpitation, dyspnea, or anginal pain. 
IIIB 
Cardiac disease resulting in marked limitations of physical activity. 
Subjects are comfortable at rest. Mild physical activity causes fatigue, 
palpitation, dyspnea, or anginal pain. 
IV* 
Cardiac disease resulting in inability to carry on any physical activity 
without discomfort. Symptoms of cardiac insufficiency or of the anginal 
syndrome may be present even at rest. If any physical activity is 
undertaken, discomfort is increased. 
 
*For all post-enrollment NYHA assessments, any patient who is inotrope dependent will be 
considered NYHA Class IV.

 
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APPENDIX 4: 6MWT PROTOCOL 
 
 
 

 
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SIX-MINUTE HALLWAY WALK TEST INSTRUCTIONS  
 
Purpose 
The purpose of the 6-Minute Hallway Walk test (6MWT) is to walk as far as possible for 6-
minutes, without running or jogging, as a way of measuring functional status. 
 
Preparing for the test 
1. Establish a 30-meter walking course in an enclosed corridor, preferably free of distractions 
and close to a wall so that if needed, the Subject may rest against it during the test (note: a 
treadmill is not an acceptable alternate method for this study).   
2. Mark the course at 3-meter intervals using a method unnoticeable to the Subject.   
3. Place noticeable markers at either end of the 30-meter course to indicate the turnaround 
points.  
4. The distance covered during the preceding walk test will not be revealed to the Subject 
during the study.  
5. A warm up prior to the test should not be performed. 
 
Explaining the test procedure to the Subject 
1. Clearly explain to the Subject what is required of him/her using the following instructions 
verbatim: 
THE PURPOSE OF THIS TEST IS TO WALK AS FAR AS POSSIBLE FOR SIX-MINUTES.  
YOU WILL START FROM THIS POINT AND FOLLOW THE HALLWAY TO THE MARKER 
AT THE END, THEN TURN AROUND AND WALK BACK.  WHEN YOU ARRIVE BACK AT 
THE STARTING POINT, YOU WILL GO BACK AND FORTH AGAIN.  YOU WILL GO BACK 
AND FORTH AS MANY TIMES AS YOU CAN IN THE SIX-MINUTE PERIOD.  IF YOU 
NEED TO, YOU ARE PERMITTED TO SLOW DOWN, TO STOP, AND TO REST AS 
NECESSARY.  YOU MAY LEAN AGAINST THE WALL WHILE RESTING, BUT RESUME 
WALKING AS SOON AS YOU ARE ABLE.  HOWEVER, THE MOST IMPORTANT THING 
ABOUT THE TEST IS THAT YOU COVER AS MUCH GROUND AS YOU POSSIBLY CAN 
DURING THE SIX MINUTES.  I WILL KEEP TRACK OF THE NUMBER OF LAPS YOU 
COMPLETE AND I WILL LET YOU KNOW WHEN THE SIX MINUTES ARE UP.  WHEN I 
SAY STOP, PLEASE STAND RIGHT WHERE YOU ARE. 
DO YOU HAVE ANY QUESTIONS ABOUT THE TEST? 
PLEASE EXPLAIN TO ME WHAT YOU ARE GOING TO DO. 
 
2. The Subject will re-state the instructions.  If the Subject does not seem to understand, 
repeat the entire instructions. 
 
Conducting the test 
1. Position the Subject at the starting line.   
2. Repeat the sentence: 
THE MOST IMPORTANT THING ABOUT THE TEST IS THAT YOU COVER AS MUCH 
GROUND AS YOU POSSIBLY CAN DURING THE SIX MINUTES. 
ARE YOU READY? 
START NOW, OR WHENEVER YOU ARE READY.

 
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3. Start the timer as soon as the Subject takes the first step.   
4. During the test, the walking pace of the Subject should not be influenced.  The test 
supervisor must walk behind the Subject – do not walk with, rush up behind, or rush past 
the Subject. 
5. Each time the Subject returns to the starting line, record the lap. 
6. While walking, encourage the Subject at one minute intervals with the following phrases: 
 
1 minute: 
YOU ARE DOING WELL.  YOU HAVE 5 MINUTES TO GO.  
2 minutes: 
KEEP UP THE GOOD WORK.  YOU HAVE 4 MINUTES TO GO. 
3 minutes: 
YOU ARE DOING WELL.  YOU ARE HALFWAY DONE. 
4 minutes: 
KEEP UP THE GOOD WORK.  YOU HAVE ONLY 2 MINUTES LEFT. 
5 minutes: 
YOU ARE DOING WELL.  YOU HAVE ONLY ONE MINUTE TO GO. 
 
7. The Subject should be spoken to only during the 1-minute encouragements; no 
response should be made to the Subject’s questions about the time and distance 
elapsed.   
a. If the Subject is not concentrating on the walking, the Subject can be reminded at a 
1-minute mark: 
THIS IS A WALKING TEST, TALKING WILL UTILIZE YOUR ENERGY RESERVE 
AND INTERFERE WITH YOUR PERFORMANCE. 
 
7. When only 15 seconds remain, state: 
IN A MOMENT I AM GOING TO TELL YOU TO STOP.  WHEN I DO, STOP RIGHT 
WHERE YOU ARE AND I WILL COME TO YOU.   
 
9. When the timer reads 6-minutes, instruct the Subject to STOP and walk over to him/her. 
Consider bringing a chair if the Subject appears exhausted.  Mark the spot where the 
Subject stopped.   
  
If the Subject wishes to stop walking during the test 
If the Subject is slowing down and expresses that he/she wants to pause, keep the timer 
running and state: 
REMEMBER, IF YOU NEED TO, YOU MAY LEAN AGAINST THE WALL UNTIL YOU 
CAN CONTINUE WALKING AGAIN. 
 
If the Subject wishes to stop before the 6-minutes are complete and refuses to continue 
(or you decide that he/she should not continue), provide a chair for the Subject to sit on 
and discontinue the test.  Record the distance completed, the time the test was stopped 
and the reason for pre-maturely stopping.   
 
Immediately after the test 
1. Total the number of completed laps and add the additional distance covered in the 
final partial lap.  Record the distance walked to the nearest meter. 
2. Observe the Subject sitting in a chair for at least 10 minutes after the test is 
completed.  

 
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APPENDIX 5: MODIFIED RANKIN SCORE 
 

 
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Score 
Definition1  
0 
No observed neurological symptoms 
1 
No significant neurological disability despite symptoms; able to 
carry out all usual duties and activities 
2 
Slight neurological disability; unable to carry out all previous 
activities, but able to look after own affairs without assistance 
3 
Moderate neurological disability; requiring some help, but able to 
walk without assistance 
4 
Moderate severe neurological disability; unable to walk without 
assistance and unable to attend to own bodily needs without 
assistance 
5 
Severe neurological disability; bedridden, incontinent and 
requiring constant nursing care and attention as a result of a 
neurological deficit 
6 
Dead 
 
                                                
 
 
 
 
 
1 van Swieten J, Koudstaal P, Visser M, Schouten H, et al (1988). “Interobserver agreement for the 
assessment of handicap in stroke Subjects”. Stroke 19 (5): 604-607 

 
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APPENDIX 6: INTERMACS DEFINITIONS FOR INTENDED USE 
OF DEVICE 

 
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Bridge to recovery - Use of a durable device to allow recovery from chronic 
cardiac failure (at least 3 months in duration) 
 
Rescue therapy - Use of a durable device to support resolution from an acute event without 
major previous cardiac dysfunction 
 
Bridge to transplant– This is for a patient ALREADY listed for transplant or listed within 24 
hours before device implantation 
 
Possible bridge to transplant - Likely to be eligible: defines a patient in whom the transplant 
evaluation has not been completed, but no contra-indications are anticipated, or in whom a 
current contra-indication is anticipated to resolve rapidly, such as recent infection. 
 
Possible bridge to transplant - Moderate likelihood of becoming eligible:  similar to above, but 
with some potential concerns that might prevent eligibility. 
 
Possible bridge to transplant - Unlikely to become eligible: should be used for a patient in 
whom major concerns have already been identified.  These may not have been quantified yet, 
such as in a patient with known chronic lung disease without recent pulmonary function test 
measurement, or might be reversible, such as severe renal insufficiency or pulmonary 
hypertension that might improve after chronic mechanical support.  It may be the expectation at 
the time of implant that the patient will most likely have the assist device as “permanent” or 
“destination” therapy.   
 
Destination therapy - patient definitely not eligible for transplant.