Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol: Post-Approval Continued Follow-up
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. 
CIP Posting Cover Page  
 
NCT Number: NCT02892955 
MOMENTUM 3 CAP 
Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ 
Continued Access Protocol: Post-Approval Continued Follow-up 
Study Document No: ABT-CIP-10440 
Version A 
Date: 14-JAN-2019 
Sponsor 
Abbott 
6035 Stoneridge Dr. 
Pleasanton, CA 94588 
United States 

 
Thoratec® LLC 
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Post-Approval Continued Follow-up 
 
 
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Thoratec® LLC 
 
 
MOMENTUM 3 
Multi-Center Study of MagLev Technology in Patients 
Undergoing MCS Therapy with HeartMate 3™ 
 
 
Continued Access Protocol: 
Post-Approval Continued Follow-up 
 
 
PMA P160054 
 
 
 
 
 
 
 
Sponsor: 
Thoratec LLC 
6035 Stoneridge Drive 
Pleasanton, CA 94588 
Thoratec is a wholly owned subsidiary of Abbott. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table of Contents 
TABLE OF APPENDICES.....................................................................................................5 
List of Tables........................................................................................................................5 
List of Figures ......................................................................................................................5 
List of Abbreviations .............................................................................................................6 
1 
Introduction ...................................................................................................................9 
2 
Indications for Use .......................................................................................................10 
3 
Device Description and Theory of Operation.................................................................10 
4 
Device Testing.............................................................................................................11 
4.1 
Device Testing: Bench .......................................................................................11 
4.2 
Device Testing: In Vivo ......................................................................................12 
5 
Study Design ...............................................................................................................12 
6 
Study Population .........................................................................................................14 
7 
Number of Clinical Sites and Subjects ..........................................................................14 
8 
Study Duration.............................................................................................................14 
9 
Study Objectives..........................................................................................................14 
9.1 
Primary Study Objective.....................................................................................14 
10 Clinical Study Endpoints ..............................................................................................14 
11 Inclusion Criteria ..........................................................................................................14 
12 Exclusion Criteria.........................................................................................................15 
13 Data Analysis and Statistical Issues/Justification for Study Design ................................16 
13.1 General Statistical Analysis Plan ........................................................................16 
13.2 Sample Size ......................................................................................................16 
13.3 Analysis of Descriptive Endpoints.......................................................................16 
13.4 Analysis of Adverse Events ................................................................................17 
13.5 Analysis of Device Malfunctions .........................................................................17 
13.6 Analysis of Pre-Implant Data ..............................................................................17 
13.7 Analysis of Implant and Discharge Data .............................................................17 
13.8 Analysis of Functional Status .............................................................................17 
13.8.1 
NYHA ..................................................................................................17 
13.8.2 
Six Minute Walk Test ...........................................................................17 
13.9 Analysis of Quality of Life ...................................................................................17 
13.9.1 
EQ-5D-5L ............................................................................................18 
13.9.2 
KCCQ .................................................................................................18 
13.10 Analysis of Blood Pressure ................................................................................18 
13.11 Analysis of Echocardiographic Data ...................................................................18 
14 Adverse Events (AE) ...................................................................................................18 
14.1 Adverse Events .................................................................................................18 
14.2 Serious Adverse Event (SAE) ............................................................................18 

 
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15 Optional Biobank Substudy ..........................................................................................19 
16 Study Procedures and Assessments ............................................................................19 
16.1 Screening and Enrollment ..................................................................................19 
16.2 Baseline Assessments .......................................................................................19 
16.3 Implant 20 
16.4 Post Op Day 1 (+/- 1 Day) ..................................................................................20 
16.5 1 Week Post-implant (+/- 1 Day).........................................................................21 
16.6 Discharge (-1 day) .............................................................................................21 
16.7 Subject Follow-up Assessments.........................................................................22 
16.7.1 
Clinic Follow-up Post-implant: 30 Days (+/- 7 days) for 1 month 
assessment, and 180 days (+/- 30 days) for 6 month assessment .........22 
16.7.2 
Clinic Follow-up Post-implant: 360 Days (+/- 30 days) for 12 month 
assessment, and 720 Days (+/- 30 days) for 24 month assessment ......23 
16.8 Additional Data Collection ..................................................................................24 
16.8.1 
Pump Log Files....................................................................................24 
16.8.2 
Health Economics Data .......................................................................24 
16.8.3 
Blood Pressure Data............................................................................24 
16.8.4 
Echocardiographic Data.......................................................................25 
16.8.5 
Blood and Urine Samples (Optional Biobank Substudy)........................26 
17 Anticoagulation ............................................................................................................26 
18 Infection Control Guidelines .........................................................................................26 
19 Blood Pressure Guidelines...........................................................................................26 
20 Post-mortem Examination ............................................................................................27 
21 Device Retrieval and Analysis ......................................................................................27 
22 Subject Withdrawal ......................................................................................................27 
23 Risks ...........................................................................................................................27 
24 Mitigations ...................................................................................................................29 
25 Benefits .......................................................................................................................29 
26 Ethical Requirements...................................................................................................29 
26.1 Informed Consent ..............................................................................................29 
26.2 IRB Review .......................................................................................................30 
26.3 Confidentiality ....................................................................................................30 
27 Protocol Deviations ......................................................................................................30 
28 Protocol Amendments..................................................................................................31 
29 Data Collection, Case REport Forms and Record Keeping Requirements .....................31 
29.1 Database and Electronic Case Report Forms (eCRFs) .......................................31 
29.2 Device Accountability Records ...........................................................................31 
29.3 Source Documentation ......................................................................................31 
29.4 Maintenance of Study Documentation ................................................................31 
29.5 Regulatory Reporting Requirements...................................................................32 

 
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29.5.1 
Site Reporting......................................................................................32 
29.5.2 
Sponsor Reporting...............................................................................32 
29.6 Retention of Records .........................................................................................32 
29.7 Laboratory Accreditation and Normal Values ......................................................33 
30 Insurance ....................................................................................................................33 
31 Quality Control.............................................................................................................33 
31.1 Independent Monitoring Boards .........................................................................33 
31.1.1 
Clinical Events Committee (CEC): ........................................................33 
31.2 Investigator Selection.........................................................................................33 
31.3 Site Selection ....................................................................................................33 
31.4 Site Staff Training ..............................................................................................33 
31.5 Monitoring .........................................................................................................34 
31.6 Investigator and/or Study Site Termination/Suspension ......................................34 
31.7 Early Study Termination.....................................................................................34 
32 Emergency Contacts ...................................................................................................35 
33 Publication Policy ........................................................................................................35 
34 Study Visit Schedule ....................................................................................................36 
35 References ..................................................................................................................39 
 
 
 
 
 
 
 

 
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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 
7 
Biobank Substudy Clinical Investigation Plan 
 
 
 
 
 
LIST OF TABLES 
Table 1 – Incidence Rates of Adverse Events ........................................................................ 28 
Table 2 – Schedule of Events ................................................................................................ 36 
 
 
 
 
 
LIST OF FIGURES 
Figure 1 – HeartMate 3 System during Battery-powered Operation......................................... 11 
Figure 2 – Study Flow............................................................................................................ 13 
 
 

 
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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) 
CAP ................. Continued Access Protocol 
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 
FWA................. Federal Wide Assurance 

 
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LIST OF ABBREVIATIONS 
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 
PAS………….... Post-Approval Study 
PI ..................... Principal Investigator 
PMA ................. Premarket Approval 
PRBC ............... Packed Red Blood Cells 
PT .................... Prothrombin Time 
PTT.................. Partial Thromboplastin Time 

 
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LIST OF ABBREVIATIONS 
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, LLC 
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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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 lives1-3,9.  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 MOMENTUM 3 Investigational Device Exemption (IDE) 
clinical trial is a prospective, multicenter, randomized pivotal study with an innovative 
trial design comparing the HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) 
with the HM II LVAS in advanced-stage heart failure patients. It was conducted at 69 US 
investigative centers and enrolled 1028 patients in a 1:1 randomized fashion stratified by 
site. 
 
The HM3 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). This study included multiple pre-specified cohorts: 1. A Safety 
Cohort (N=30) in lieu of a pilot study, 2. A Short Term (ST) Cohort of first 294 patients 
(including the 30 patients in the Safety Cohort) powered to demonstrate non-inferiority of 
HM3 to HM II at 6 months for survival free of debilitating stroke and device replacement, 
3. A Long Term (LT) Cohort of first 366 patients (including patients in the ST Cohort) 
powered to demonstrate non-inferiority at 2 years, 4. A Full Cohort of all 1028 patients 
powered to demonstrate superiority of HM3 to HM II for pump replacement at 2 years. 
Adults with an ejection fraction ≤ 25%, in New York Heart Association (NYHA) Class III 
with dyspnea on mild physical activity or NYHA Class IV, inotrope dependent or with 
Cardiac Index (CI) ≤ 2.2 l/min/m2 while not on inotropes and who were either on optimal 
medical management for 45 of 60 days or listed for transplant were enrolled in this study 
after obtaining signed informed consent. 
 
The first patient was enrolled in MOMENTUM 3 on September 2, 2014. Enrollment in the 
ST cohort was completed on October 14, 2015 with 6-month follow-up completed on 
April 13, 2016.  A Premarket Approval (PMA) application in support of a short-term 
indication for use was submitted to FDA and approval was received in August 2017.  
The LT Cohort completed enrollment on November 7, 2015 and the full trial cohort 
(n=1028) completed enrollment on August 23, 2016; 24-month follow-up for the LT 
cohort was completed in November 2017 and in September 2018 for the full trial cohort.  
 
In August 2016, following completion of enrollment in the full cohort of MOMENTUM 3, 
FDA approved a Continued Access Protocol (CAP).  Enrollment in the CAP began on 
August 31, 2016. Approval for the long-term indication was received from the FDA on 
October 18, 2018. The last implant in CAP occurred on October 25, 2018 for a total 
enrollment of 1685 patients. As a condition of approval, all patients enrolled in the CAP 

 
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study will complete the 24 month follow-up specified in this protocol to fulfil a post-
approval study (PAS) requirement. 
 
2 
INDICATIONS FOR USE 
The HM3 LVAS is indicated for providing short- and long-term mechanical circulatory 
support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in 
patients with advanced refractory left ventricular heart failure. 
3 
DEVICE DESCRIPTION AND THEORY OF OPERATION 
The HM3 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 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. 
Subjects implanted with HM3 will be discharged from the hospital with the MPU, without 
the system monitor, as their primary source of power. 
 
The HM3 LVAD is part of the HM3 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). 

 
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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 HM3 Controller is also part of the HM3 LVAS. The Controller is an extracorporeal 
interface device that receives power from the Power Module, Mobile 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. 
 
 
A complete list of HM3 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 HM3 IFU. 
 
4 
DEVICE TESTING 
4.1 
Device Testing: Bench 

 
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The HM3 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 HM3 IFU 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 HM3 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.  
5 
STUDY DESIGN 
The study will be a single arm, prospective, multi-center study for continued evaluation 
of safety and clinical performance of the HM3 LVAS. Subjects who receive a device 
exchange to any device other than HM3, at any time during the study, will be withdrawn 
from the study and will not be followed any further in the trial. This study fulfills a PAS 
requirement as part of the FDA condition of approval for the long-term indication. 

 
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Figure 2 – Study Flow 
 
 
 

 
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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 at 68 clinical sites. A total of 1685 subjects were enrolled in 
the MOMENTUM 3 CAP.  
8 
STUDY DURATION 
Enrollment in the study was completed after 26 months.  All Subjects will be followed for 
24 months or to outcome (transplant, explant, or death), whichever occurs first. 
9 
STUDY OBJECTIVES 
9.1 
Primary Study Objective 
The primary objective of the study is to continue to evaluate the safety and clinical 
performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular 
heart failure. 
10 
CLINICAL STUDY ENDPOINTS 
All endpoints will be descriptively compared to the arms of the MOMENTUM 3 IDE trial. 
• 
Composite of survival to transplant, recovery, or LVAD support free of debilitating 
stroke (Modified Rankin Score > 3) or reoperation to replace the pump at 6 and 24 
months 
• 
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 
• 
Outcome: Overall Survival 
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: 

 
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• 
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 
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 ≥ 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 

 
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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 
19) Patients actively listed for heart transplant (this exclusion applies only after 
commercial approval of the HM3 for short-term use) 
13 
DATA ANALYSIS AND STATISTICAL ISSUES/JUSTIFICATION FOR STUDY 
DESIGN 
13.1 
General Statistical Analysis Plan 
The HM3 continued access study will investigate the continued safety and clinical 
performance of the HM3 LVAS for short term hemodynamic support, such as a bridge to 
cardiac transplantation (BTT) or myocardial recovery, or for long term support, such as 
destination therapy (DT). It is a single arm, prospective, multicenter, study. 
 
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.  Missing data will not be imputed except as described below. 
 
Quality of Life and functional improvement will be compared to baseline scores using a 
mixed model or a Wilcoxon test, as appropriate. 
 
All data will be considered adjunctive data to the MOMENTUM 3 IDE trial and will be 
presented descriptively as a separate cohort.   
13.2 
Sample Size 
CAP enrollment completed in October 2018 for a total of 1685 subjects. 
13.3 
Analysis of Descriptive Endpoints 
All endpoints will be descriptively compared to the arms of the MOMENTUM 3 IDE trial. 
 
Descriptive endpoints include: 
• 
Composite of Survival to transplant, recovery or LVAD support free of debilitating 
stroke (Modified Rankin Score >3) or reoperation to replace the pump at 6 and 24 
months 
• 
Quality of Life as measured by EuroQoL 5D-5L (EQ-5D-5L) and Kansas City 
Cardiomyopathy Questionnaire (KCCQ) 
• 
Functional status as measured by the 6-minute walk test (6MWT) and NYHA 
classification 
• 
Frequency and incidence of all re-operations 
• 
Frequency and incidence of all rehospitalizations 
• 
Frequency, incidence and rates of pre-defined anticipated adverse events 
• 
Frequency and incidence of device malfunctions 
• 
Frequency and incidence of pump replacement 

 
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• 
Overall Survival 
13.4 
Analysis of Adverse Events 
All pre-defined adverse events will be captured. Tables will be created that show the 
incidences of all adverse events and the event rate per patient year of support.  Serious 
adverse events (SAEs) will be analyzed in a similar manner as AEs. 
13.5 
Analysis of Device Malfunctions 
All suspected HM3 device malfunctions will be reported. The Sponsor 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 Sponsor 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 
13.6 
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. 
13.7 
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. 
13.8 
Analysis of Functional Status 
13.8.1 
NYHA 
The Subjects NYHA Functional Status will be assessed by an independent 
assessor at baseline and then at 1, 6, 12, 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. 
13.8.2 
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, 6, 12, and 24 post implant.  Data will be 
analyzed using mixed modeling by comparing the distances walked over time 
to the baseline distance. 
13.9 
Analysis of Quality of Life 
Quality of Life will be measured using the EuroQol (EQ-5D-5L) and the Kansas City 

 
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Cardiomyopathy Questionnaire (KCCQ). 
13.9.1 
EQ-5D-5L 
The EQ-5D-5L VAS and total score will be assessed at baseline and then at 1, 
6, 12, 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. In addition, the percentage of each component of the EQ-5D-5L will be 
graphically presented over time. 
13.9.2 
KCCQ 
The KCCQ score will be assessed at baseline and then at 6, 12, and 24 
months. Data will be analyzed using mixed modeling by comparing the KCCQ 
score at each assessment interval to the baseline score. 
13.10 Analysis of Blood Pressure 
The accuracy of various blood pressure (BP) techniques will be evaluated including 
arterial line, automated BP cuff and Doppler. To evaluate the accuracy of the automated 
cuff, systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be correlated 
to the same measurements obtained from the arterial line.  Similarly, the Doppler 
measurement will be correlated individually to SBP, DBP, as well as the mean arterial 
pressure (MAP) derived from the arterial line.  Doppler BP will also be correlated with the 
automated cuff measurements. The correlation of MAP and pulse pressure with death, 
stroke, bleeding, and symptomatic dizziness will also be evaluated. 
13.11 Analysis of Echocardiographic Data 
Paired t-test testing or Wilcoxon signed rank testing (for correlated data) will be used to 
compare aortic valve (AV) opening duration and degree of opening with pulse pressure 
(obtained from BP measurement) and/or pulse perception (pulse yes or no) at each 
follow-up period.  Events will be calculated as event rates and compared based on 
dichotomized AV function (to be determined based on data distribution).   
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.  

 
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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 
OPTIONAL BIOBANK SUBSTUDY 
The Biobank Substudy is an optional substudy of the MOMENTUM 3 CAP. 
 
The proposed research will aim to address current gaps in knowledge in regards to 
molecular changes with LVAD placement by creating a biobank of blood and urine 
samples from a subset of subjects enrolled in the MOMENTUM 3 CAP. The long-term 
aim of this study is to assess longitudinally blood and urine biomarkers in subjects with 
stage D HF who are undergoing implantation of LVADs. This study design will allow for 
an exploration of the levels and variability of known biomarkers at different stages of 
mechanical circulatory support and allow for the discovery of novel markers in the future. 
This collection for future medical research is intended to expand translational R&D 
capability and will support future research aims that will advance our understanding of 
advanced HF and options for treatment.  
 
See Appendix 7 for a complete description of the Biobank Substudy.  
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 
Subject who meets all inclusion and no exclusion criteria at the time written informed 
consent is obtained, and is implanted with the HM3 LVAS will be considered enrolled in 
this study 
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. 
16.2 
Baseline Assessments 
The following baseline assessments will be performed within 30 days prior to implant 
(refer to Table 2 – Schedule of Events 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, 

 
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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) 
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) 
13. Blood and Urine Sample Collection (only for optional Biobank Substudy) 
 
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 
4. HM3 Pump Log files (pump period log, pump event log, controller period log, and 
controller event log) will be submitted to the Sponsor (only if a pump-related or 
possibly related AE or malfunction has occurred) 
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) 
16.4 
Post Op Day 1 (+/- 1 Day) 
1. HM3 Pump Log files (pump period log, pump event log, controller period log, and 

 
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controller event log) will be submitted to the Sponsor (only if a pump-related or 
possibly related AE or malfunction has occurred) 
2. Echocardiogram or transesophageal echocardiogram (TEE): LVEF, LVEDD, LVESD, 
AV opening, AI, MR, TR including severity and/or grade (can be performed on post- 
operative day 0 (post-implant) +2 days). Protocol for echocardiographic assessments 
as well as additional data to be acquired are described in section 17.8.5 
3. Blood Pressure (please refer to section 17.8.4 for details on data collection) 
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 (including blood pressure – see section 17.8.4) 
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. Protocol for echocardiographic assessments as well as additional data 
to be acquired are described in section 17.8.5 
7. Pump Parameters 
8. HM3 Pump Log files (pump period log, pump event log, controller period log, and 
controller event log) will be submitted to the Sponsor (only if a pump-related or 
possibly related AE or malfunction has occurred) 
9. Occurrence of AEs (date of adverse event, determination of seriousness and/or 
relation to the device, resolution of the event) 
10. Device Malfunctions 
11. Reoperations/Operative procedures 
12. Pump Replacements/Explants/Device Exchanges 
13. Driveline Management Assessment 
14. 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) 
15. Blood and Urine Sample Collection (only for optional Biobank Substudy) 
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 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 

 
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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 (including blood pressure – please see section 17.8.4) 
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. Protocol for echocardiographic assessments as well as 
additional data to be acquired are described in section 17.8.5 
8. 
NYHA Classification (determined by an independent assessor defined as an 
advanced practice practitioner other than the treating investigator) 
9. 
Pump Parameters 
10. HM3 Pump Log files (pump period log, pump event log, controller period log, and 
controller event log) will be submitted to the Sponsor (only if a pump-related or 
possibly related AE or malfunction has occurred) 
11. Occurrence of AEs (date of adverse event, determination of seriousness and/or 
relation to the device, resolution of the adverse event) 
12. Device Malfunctions 
13. Reoperations/Operative procedures 
14. Pump Replacements/Explants/Device Exchanges 
15. Driveline Management Assessment 
16. Collect UB-04 Form 
17. 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, 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 (including blood pressure, please see section 17.8.4) 
5. Laboratory Assessments: 

 
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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. Protocol for echocardiographic  
assessments as well as additional data to be acquired are described in 
section 17.8.5 
7. NYHA Classification (determined by an independent assessor defined as 
an advanced practice practitioner other than the treating investigator) 
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) (180 Days only)  
11. Pump Parameters  
12. Rehospitalizations  
a. If rehospitalized, collect UB-04 form  
13. HM3 Pump Log files (pump period log, pump event log, controller period 
log, and controller event log) will be submitted to the Sponsor (only if a 
pump-related or possibly related AE or malfunction has occurred)  
14. Occurrence of AEs (date of adverse event, determination of the 
seriousness and/or relation to the device, resolution of the adverse event)  
15. Device Malfunctions  
16. Reoperations/Operative procedures  
17. Pump Replacements/Explants/Device Exchanges  
18. Driveline Management Assessment  
19. 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)  
20. Blood and Urine Sample Collection (only for optional Biobank Substudy) 
 
16.7.2 
Clinic Follow-up Post-implant: 360 Days (+/- 30 days) for 12 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 (including blood pressure – see section 17.8.4) 
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 

 
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(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. Protocol for echocardiographic assessments as well 
as additional data to be acquired are described in section 17.8.5 
7. NYHA Classification (determined by an independent assessor defined as 
an advanced practice practitioner other than the treating investigator) 
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. Pump Parameters 
12. Rehospitalizations 
a. If rehospitalized, collect UB-04 form 
13. HM3 Pump Log files (pump period log, pump event log, controller period 
log, and controller event log) will be submitted to the Sponsor (only if a 
pump-related or possibly related AE or malfunction has occurred) 
14. Occurrence of AEs (date of the adverse event, determination of 
seriousness and/or relation to device, resolution of the adverse event) 
15. Device Malfunctions 
16. Reoperations/Operative procedures 
17. Pump Replacements/Explants/Device Exchanges 
18. Driveline Management Assessment 
19. 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 Table 2 – Schedule of 
Events. 
16.8 
Additional Data Collection 
16.8.1 
Pump Log Files 
Pump parameters and pump logs must be submitted when any pump-related or 
possibly related AE or malfunction occurs.  In addition, the Sponsor may 
periodically collect pump log files, 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 
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 the Sponsor. 
16.8.3 
Blood Pressure Data 
Accurate and precise noninvasive blood pressure (BP) measurement is a 
challenge for patients supported on continuous flow LVADs. Prior reports have 
demonstrated variability in BP accuracy in patients supported with a Heartmate 

 
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II LVAD when automated cuff and Doppler measures are employed15. 
Furthermore, there are several different automated cuff machines and a direct 
comparison of accuracy of different manufacturers has not been undertaken. 
 
BP data is already being collected as part of the MOMENTUM 3 protocol, 
however as part of the CAP, additional data on BP is being collected in order to 
further the understanding of the accuracy of BP measurement techniques in 
HM3 subjects. The following data will be collected as part of this CAP: 
 
• 
BP measurement utilizing the arterial line (gold standard): systolic BP 
(SBP)/diastolic BP (DBP), mean, and pulse pressure (PP=SBP-DBP). 
These measurements will be evaluated directly from the arterial line, and 3 
measurements will be obtained for each subject within 3 minutes of each 
other. This data will be collected only if an arterial line is already in place. 
 
• 
Automated cuff BP: BP Cuff type, SBP/DBP, and mean. These values will 
be obtained no more than 3 minutes apart for 3 measures. If the cuff is 
unable to read a pressure, an X will be documented as a failure. 
 
• 
Doppler BP: These values will be obtained no more than 3 minutes apart 
for 3 measures. Equal Doppler BP measurements in both arms will be 
ensured at the time of Doppler BP measurement. 
 
• 
Documentation of palpable radial pulse (≥1 in 5 seconds) for evidence of 
pulsatility. 
 
• 
Documentation of any dizziness symptoms associated with hypotension or 
hypertension 
 
If possible, BP measurement utilizing the 3 techniques will be done at the same 
time to allow for a direct comparison. 
16.8.4 
Echocardiographic Data 
The degree and duration of AV opening is influenced by a number of 
parameters including the LVAD pump speed, native LV contractility, volume 
status (pre-load) and peripheral vascular resistance (afterload).  Recent 
guidelines, albeit based on a paucity of data, recommend, that the pump speed 
be set low enough to permit at least intermittent AV opening.  Potential and 
theoretical problems associated with persistent AV closure include the 
following: aortic fusion and development of de novo aortic insufficiency, aortic 
root status and clot formation and thromboembolic events, decreased AV 
pulsatility associated AVM formation and GI bleeding.  Potential and theoretical 
problems associated with intermittent or AV opening with every cardiac cycle 
includes partial LV unloading and recurring and/or persistent clinical heart 
failure and relatively “low flow” with lower pump speeds and associated pump 
thrombosis.  Although these mentioned clinical problems are multifactorial in 
underlying etiology a clearer understanding of AV function based on a 
prospective, multicenter protocol (MOMENTUM 3) is needed. 
 

 
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Echocardiographic data is already being collected as part of the MOMENTUM 
3 at regular follow-up intervals.  In order to further the understanding of the 
impact of AV function on clinical outcomes in HM3 subjects, additional data will 
be collected as part of the CAP.  It is recommended that the Echocardiography 
data be acquired using M-Mode at a sweep speed of 25-50 mm/sec. When the 
AV opening duration is relatively constant, a faster sweep speed (eg, 75-100 
mm/s) may be appropriate for the duration of 60 seconds. The following 
assessments should be made: 
 
• 
Duration of AV opening (ms): Measured from the same M-Mode 
acquisitions using the average of 60 seconds to report an average value as 
well as a minimum and maximum AV opening duration 
 
• 
AV opening status: Characterized into 3 types (opening every cardiac cycle, 
intermittent opening, and closed every beat) 
 
• 
AV opening area: Degree of AV opening in mm as an average of 60 
seconds as well as minimum and maximum values 
 
• 
Additional Echocardiographic data: Left Ventricular Outflow Tract Time 
Velocity Integral (TVI) and AV velocities (if present), aortic insufficiency 
grade based on standard recommendation including the LVOT jet 
width/height ratio, LVEDP by AI jet, inflow and outflow cannula systolic and 
diastolic velocities, and RV systolic function (qualitative and quantitative) 
and RV size (qualitative and quantitative). 
 
16.8.5 
Blood and Urine Samples (Optional Biobank Substudy) 
The biostorage plan calls for 5 aliquots of serum, 10 aliquots of plasma (5 
EDTA, 5 citrate) and 5 aliquots of urine.  Each aliquot will be at least 1 ml, and 
up to 1.5 ml. 
 
DNA will not be collected as part of this study. Blood and urine will be drawn at 
the pre-specified times for the measurement of blood and urine markers of 
coagulation dysfunction, fibrosis, inflammation, and endothelial dysfunction. 
 
See Appendix 7 for a complete description of the Biobank Substudy. 
17 
ANTICOAGULATION 
Subjects implanted with the HM3 must be properly anticoagulated to decrease the 
possibility of thromboembolism and/or pump thrombosis.  Anticoagulation guidelines are 
provided in the 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 HM3 LVAS.  Guidelines for infection control 
and driveline management are provided in the HM3 IFU. 
19 
BLOOD PRESSURE GUIDELINES 

 
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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 the Sponsor. 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 HM3 LVAD associated complications. 
21 
DEVICE RETRIEVAL AND ANALYSIS 
Upon Subject death, device explantation, or device malfunction, all explanted HM3 
pumps must be retrieved and returned to the Sponsor for evaluation and analysis within 
48 hours of explant.  Devices must be returned in accordance with Sponsor instructions. 
 
Any system component other than the pump, (for example: controller, MPU, batteries) 
associated with any suspected device malfunction must also be returned to the Sponsor 
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 HM3 
• 
Subject is not implanted with device after consent 
• 
Subject is lost to follow-up 
 
Subjects who can no longer be tracked for follow-up data collection at a participating 
center will be formally withdrawn from the study. 
23 
RISKS 
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. 
 
Table 1 shows the incidence rates of adverse events in patients implanted with HM3 in 
the MOMENTUM 3 IDE clinical trial. These rates and additional results from the clinical 
trial are summarized in the IFU. 
 
 

 
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Table 1 – Incidence Rates of Adverse Events  
Adverse Event 
At 6 Months: 
HM3 Short 
Term Cohort 
At 24 Months: 
HM3 Long 
Term Cohort 
Death 
11% 
16% 
Major infection 
42% 
55% 
Localized 
30% 
37% 
Sepsis 
9% 
14% 
Driveline 
12% 
24% 
Pump pocket or pseudo pocket 
1% 
1% 
Pump or pump components 
0% 
0% 
Bleeding 
33% 
43% 
Bleeding requiring surgery 
10% 
12% 
Gastrointestinal bleeding 
16% 
27% 
Cardiac arrhythmia 
31% 
38% 
Ventricular arrhythmia 
18% 
24% 
Supraventricular arrhythmia 
15% 
18% 
Both (ventricular and supraventricular arrhythmia) 
1% 
1% 
Right heart failure 
30% 
32% 
Right ventricular assist device (RVAD) 
3% 
3% 
Respiratory failure 
22% 
24% 
Renal dysfunction 
11% 
13% 
Stroke 
8% 
10% 
Hemorrhagic stroke 
3% 
4% 
Ischemic stroke 
5% 
6% 
Debilitating stroke 
6% 
7% 
Other neurological event 
6% 
12% 
Encephalopathy 
2% 
3% 
Seizure 
3% 
3% 
Transient ischemic attack (TIA) 
1% 
3% 
Other1 
1% 
3% 
Hepatic dysfunction 
5% 
4% 
Psychiatric episode 
5% 
5% 
Venous thromboembolism 
5% 
5% 

 
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Hypertension 
3% 
6% 
Arterial non-CNS thromboembolism 
2% 
2% 
Pericardial fluid collection 
2% 
2% 
Myocardial infarction 
1% 
1% 
Wound dehiscence 
1% 
1% 
Hemolysis (not associated with suspected device thrombosis) 
1% 
1% 
Suspected device thrombosis 
0% 
1% 
Other adverse events 
50% 
70% 
1Other includes anoxic brain injury, traumatic brain injury, and intracranial bleed due to trauma. 
 
The HeartMate 3 LVAS has been approved by the FDA for a short- and long-term 
support. 
 
Residual risks associated with the HM3 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 IFU. 
 
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 have undergone 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 
The HM3 LVAS has been shown to provide safe and effective hemodynamic support in 
advanced heart failure Subjects.  Results from the LT cohort of the MOMENTUM 3 IDE 
trial show that the HM3 LVAS is superior to the HM II LVAS as assessed by the primary 
endpoint of survival free of debilitating stroke or reoperation to replace the pump at two 
years. Subjects in both arms of the trial demonstrated significant improvement in 
functional status and quality of life compared to pre-implant baseline16. 
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 

 
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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 the Sponsor. 
 
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. 
 
The Sponsor 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 the Sponsor for approval, prior to 
submitting to the IRB.  Copies of the IRB submission and approval, including the 
approved ICF, must be forwarded to the Sponsor 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 the Sponsor 
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 the Sponsor.  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 security number, and medical record number, should be redacted by the 
site prior to submission to the Sponsor. 
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, 

 
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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 Sponsor 
administrator for all study personnel. The Investigator must ensure that the observations 
and study findings are recorded correctly and completely in the eCRFs. For each 
subject, a final signature page must be signed and dated by the authorized personnel 
attesting to the accurate completion of the eCRFs. 
 
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 HM3 LVAS is now a commercially approved device. Commercial devices will 
comply with tracking provisions of Section 519(e) of the FD&C Act, 21 U.S.C. 360i(e) 
and in accordance with 21 CFR Part 821.Medical Device Tracking Requirements.  
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, 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 the Sponsor, 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 the Sponsor: 
 
• 
Copy of the Study Protocol 
• 
IRB Approval(s) 

 
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• 
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 
• 
Sponsor Correspondence 
• 
Annual/Semi-annual Regulatory Reports 
• 
Documentation of Training 
• 
Monitoring Visit Log 
• 
Device Accountability (for devices used prior to October 25, 2018) 
• 
Instructions for Use (IFU) 
• 
Patient Manual 
 
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 the 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 
The Sponsor will submit Study progress reports as required by 21 CFR 
812.150(b)(5) to all reviewing IRBs at least yearly. The Sponsor 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). The Sponsor 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, 

 
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including 21 CFR Part 117. 
 
The investigator must not dispose of any records relevant to this study without either (1) 
written permission from the Sponsor or (2) providing an opportunity for the Sponsor 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 the 
Sponsor 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 the Sponsor. Throughout the study, the Investigator shall 
provide the Sponsor 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 the Sponsor in order to allow the data to be pooled. 
30 
INSURANCE 
The Sponsor will obtain insurance to cover potential injury to Subjects in accordance 
with national requirements. 
31 
QUALITY CONTROL 
31.1 
Independent Monitoring Boards 
31.1.1 
Clinical Events Committee (CEC): 
An independent CEC comprised of experienced experts in the field, will review 
and adjudicate endpoint 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 
The sites and the investigators include those who have been trained on the 
MOMENTUM 3 Clinical trial with the site having enrolled at least one patient in the 
MOMENTUM 3 study. 
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 have 

 
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undergone training by the Sponsor or designee, and documentation of that training will 
have been maintained. The HM3 LVAS Instructions for Use will be provided to assist the 
healthcare team on the proper care and operation of the device. 
31.5 
Monitoring 
The Sponsor is responsible for monitoring the study.  The Sponsor 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, the Sponsor 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, the Sponsor 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. 
31.6 
Investigator and/or Study Site Termination/Suspension 
A pattern of non-compliance and continued deviations will result in the Sponsor 
instituting a formal written request for corrective action.  If there is an inadequate 
response from the Investigator, the Sponsor may cease shipment of the investigational 
device and notify the IRB of this action. 
 
The Sponsor 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, the Sponsor will notify the appropriate regulatory authority, and/or other 
participating centers as required by local and national regulations. 
31.7 
Early Study Termination 
The Sponsor reserves the right to discontinue the study prior to fulfillment of the 
intended number of Subjects. The Sponsor intends to exercise this right only for valid 
scientific or administrative reasons.  After such a decision, all unused investigational 
products must be returned to the Sponsor and all collected data must be entered into 
EDC. 
 
The study could be prematurely discontinued in the following cases: 
• 
New findings about HM3 LVAS that changes the risk/benefit ratio where the risk to 

 
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study Subjects is unacceptable 
• 
For any other valid scientific or administrative reason(s) as determined by the 
Sponsor 
32 
EMERGENCY CONTACTS 
The Sponsor 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 
STUDY VISIT SCHEDULE 
 
Table 2 – Schedule of Events 
 
Screening1 
Baseline1 
Implant 
Post-Op 
Day 1 
(+/- 1 day) 
1 Week 
Post Implant 
(+/- 1 day) 
Discharge 
(-1 day) 
30 Days 
Post 
Implant 
(+/- 7 
days) 
180 Days 
Post 
Implant 
(+/- 30 
days) 
360 Days 
Post 
Implant 
(+/- 30 
days) 
720 Days 
Post 
Implant 
(+/- 30 
days) 
As 
Occurs 
Inclusion/ Exclusion 
X 
 
 
 
 
 
 
 
 
 
 
Enrollment 
X 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
Intended Use11 
X 
 
 
 
 
 
 
 
 
 
 
General and Cardiac Medical 
History 
 
X 
 
 
 
 
 
 
 
 
 
Current Medications / 
Cardiovascular Medications9 
 
X 
X 
 
X 
X 
X 
X 
X 
X 
 
Physical Exam 
 
X 
 
 
 
 
 
 
 
 
 
Vital Signs2 
 
X 
 
X
18 
X 
X 
X 
X 
X 
X 
 
Hemodynamic 
Measurements3 
 
X 
 
 
 
 
 
 
 
 
 
Laboratory 
Assessments 
 
X 
 
 
X 
X 
X 
X 
X 
X 
 
Echocardiogram 
 
X 
 
X14 
X 
X 
X 
X 
X 
X 
 
ECG 
 
X 
 
 
 
 
 
 
 
 
 
Modified Rankin Score16 
 
X 
X6 
 
X6 
X6 
X6 
X6 
X6 
X6 
X6 
NYHA Classification 5 
 
X 
 
 
 
X 
X 
X 
X 
X 
 
INTERMACS Profile15 
 
X 
 
 
 
 
 
 
 
 
 
6 Minute Walk Test 
 
X 
 
 
 
 
X 
X 
X 
X 
 
EQ-5D-5L 
 
X 
 
 
 
 
X 
X 
X 
X 
 
KCCQ 
 
X 
 
 
 
 
 
X 
X 
X 
 
VO2  Max10 
 
X 
 
 
 
 
 
 
 
 
 
Blood & Urine Collection17 
 
X 
 
 
X 
 
X 
X 
 
 
 
Implant Data/CPB Time/Blood 
 
 
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) 
180 Days 
Post 
Implant 
(+/- 30 
days) 
360 Days 
Post 
Implant 
(+/- 30 
days) 
720 Days 
Post 
Implant 
(+/- 30 
days) 
As 
Occurs 
Products 
HM3 Pump Parameters 7 
 
 
X 
 
X 
X 
X 
X 
X 
X 
X7 
Concurrent Procedures at Pump 
Implant 
 
 
X 
 
 
 
 
 
 
 
X 
Subject Status 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Subject Outcome 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
ICU Time 
 
 
 
 
 
X 
 
 
 
 
 
Rehospitalizations 
 
 
 
 
 
 
X 
X 
X 
X 
X 
HM3 Pump Log Files8 
 
 
X13 
X13 
X13 
X13 
X13 
X13 
X13 
X13 
X13 
Adverse Events 4 
 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
Device Malfunctions4 
 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
Operative 
Procedures4 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Pump Replacements / Explants / 
Exchanges 4 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Driveline 
Management 
Assessment 
 
 
 
 
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. 
7 HM3 Pump Parameters include: Pump Flow, Pump Speed, Pulsatility Index and Pump Power. In addition to defined scheduled collection of pump parameters, they must also 
be submitted when any pump-related or possibly related AE or malfunction occurs. 
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. 

 
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13 Pump logs must be submitted when any pump-related or possibly related AE or malfunction occurs. 
14 Post-operative TEE is also acceptable; can be performed POD 0 (post-implant) + 2 days. 
15 INTERMACS profile to be assessed immediately prior to implantation 
16Must be performed by an independent assessor; defined as an independent, trained, and certified clinician 
17Applies only to subjects participating in the optional Biobank substudy 
18Blood pressure only

 
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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 
15. Lanier GM et al. Validity and Reliability of a Novel Slow Cuff-Deflation System for 
Noninvasive Blood Pressure Monitoring in Patients With Continuous-Flow Left 
Ventricular Assist Device. Circ Heart Failure 2013;6:1005-12 
16. Mehra MR, Goldstein DJ, Uriel N et al. Two-Year Outcomes with a Magnetically 
Levitated Cardiac Pump in Heart Failure. New England Journal of Medicine. 
2018;378(15):1386-95. 
 

 
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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 

 
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external to the patient and can be replaced or repaired without the need for further surgery. 
 
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 the Sponsor 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- 

 
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hypertensive therapy. 
 
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. 
 

 
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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 
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? 

 
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START NOW, OR WHENEVER YOU ARE READY. 
 
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. 
 
b. 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. 
 
8. 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. 

 
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APPENDIX 7: BIOBANK SUBSTUDY CLINICAL INVESTIGATION PLAN

 
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Serum, Plasma, and Urine Biobank of Continuous Flow LVAD 
Recipients 
 
MOMENTUM 3 CAP SUBSTUDY 
CLINICAL INVESTIGATION PLAN 
 
 
 
Sponsored By: 
 
 
 
Thoratec, LLC 
Pleasanton, CA 
 
 
Thoratec is the sponsor of the MOMENTUM 3 and the MOMENTUM 3 CAP Trials and is a 
wholly owned subsidiary of Abbott. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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TABLE OF CONTENTS 
TABLE OF APPENDICES ..................................................................................................60 
LIST OF FIGURES .............................................................................................................60 
LIST OF ABBREVIATIONS ................................................................................................61 
1 
Study Synopsis............................................................................................................62 
2 
Introduction .................................................................................................................64 
3 
Substudy Design .........................................................................................................65 
4 
Study Course and Duration ..........................................................................................65 
5 
Study Population .........................................................................................................66 
5.1 
Inclusion Criteria ................................................................................................66 
5.2 
Exclusion Criteria...............................................................................................66 
6 
Objectives ...................................................................................................................66 
6.1 
Primary Objective ..............................................................................................66 
6.2 
Exploratory Objectives .......................................................................................66 
7 
Risks ...........................................................................................................................67 
8 
Ethical Considerations .................................................................................................67 
8.1 
Informed Consent ..............................................................................................67 
8.2 
IRB Review .......................................................................................................67 
8.3 
Confidentiality ....................................................................................................68 
9 
Biobank Samples.........................................................................................................68 
9.1 
Optimization of Samples ....................................................................................68 
9.2 
Potential Biomarkers..........................................................................................69 
 

 
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LIST OF FIGURES 
Figure 1 – Stage D HF Results in Dysfunction in Several Interconnected Biological Pathways 
that Promote Disease Progression (1) ................................................................................... 65 
Figure 2 – Study Flow - Blood (both plasma and serum) and urine samples will be collected to 
coincide with data obtained as part of the MOMENTUM 3 CAP. ............................................. 66 
 
 
 
 
 
TABLE OF APPENDICES 
APPENDIX A: Plasma & Serum Sample Collection, Processing, and Shipping Procedure ...70 
 

 
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LIST OF ABBREVIATIONS 
6MWT....................... 6 Minute Walk Test 
CAP .......................... Continued Access Protocol 
cc.............................. Milliliter (cubic centimeter) 
CRF .......................... Case Report Form 
CV ............................ Cardiovascular 
EDTA ........................ Ethylenediaminetetraacetate  
ELISA ....................... Enzyme-linked Immunosorbent Assay 
FDA .......................... Food and Drug Administration 
g ............................... times gravity (also known as relative centrifugal force) 
HF ............................ Heart Failure 
HM3.......................... Heartmate 3 
ICF ........................... Informed Consent Form 
IDE ........................... Investigational Device Exemption 
INTERMACS............. Interagency Registry for Mechanically Assisted Circulatory Support 
IRB ........................... Institutional Review Board 
LVAD ........................ Left Ventricular Assist Device 
LVAS ........................ Left Ventricular Assist System 
ml.............................. Milliliter 
QOL.......................... Quality of Life 
ul .............................. Microliter 
VAD .......................... Ventricular Assist Device 
 
 
 
 
 

 
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1 
STUDY SYNOPSIS 
STUDY SYNOPSIS 
Title: 
Serum, Plasma, and Urine Biobank of Continuous Flow LVAD 
Recipients: A MOMENTUM 3 Continued Access Protocol (CAP) 
Substudy 
Acronym: 
MOMENTUM 3 Biobank 
Purpose: 
The purpose of this study is to establish a biobank of serum, 
plasma, and urine from subjects in the MOMENTUM 3 CAP.  
Objective: 
Primary Objective 
To establish a biobank of blood and urine samples at various time 
points pre- and post LVAD placement, which can be used for 
future assessment of cardiovascular (CV) specific biomarkers 
including potential analyses of coagulation system, HF 
biomarkers, etc. 
 
Exploratory Objectives 
• 
To correlate biomarkers with echocardiographic 
parameters 
• 
To find relationships between CV biomarkers and risk of 
thrombosis/bleeding 
• 
To find relationships between CV biomarkers and 
hospitalization/death 
Endpoints: 
The establishment of a biobank repository of MOMENTUM 3 CAP 
subject plasma, serum and urine samples.   
Design: 
This substudy is a longitudinal, multi-center, single-arm study 
exploring blood and urine expression levels of CV biomarkers in 
subjects who are undergoing LVAD implantation. Subjects will 
have urine and blood samples taken at baseline, 7, 30, and 180 
days post-implant. 
Devices Used: 
HeartMate 3 Left Ventricular Assist System (LVAS) 
Study Population 
The study will include 200 subjects who are enrolled in the 
MOMENTUM 3 CAP, who elect to participate in the MOMENTUM 
3 Biobank.   

 
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STUDY SYNOPSIS 
Inclusion/Exclusion 
Criteria 
Inclusion Criteria 
1. Subject or legally authorized representative has signed the 
Informed Consented Form (ICF) for the MOMENTUM 3 
CAP  
2. Subject or legally authorized representative has signed the 
ICF for the MOMENTUM 3 Biobank 
Exclusion Criteria 
1. Inability to have pre-operative blood draw performed 
Sample Collection 
The current biostorage plan calls for 5 aliquots of serum, 10 
aliquots of plasma (5 EDTA, 5 citrate) and 5 aliquots of urine. 
Each aliquot will be at least 1 ml, and up to 1.5 ml. 
Sample Analysis 
Once the biobank is established, the MOMENTUM 3 investigators 
will be able to submit proposals to utilize the biobank for sample 
analysis. A biobank subcommittee will evaluate and make 
assessments on these study proposals. 

 
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2 
INTRODUCTION  
Of the approximately 5.8 million Americans with heart failure (HF), up to 10% have stage 
D HF, defined as symptoms refractory to medical therapy. These patients face a grave 
prognosis, with mortality rates approaching 50%, and treatment options limited to 
cardiac transplantation, left ventricular assist devices (LVADs), and hospice care. Since 
transplantation is limited to <2% of advanced HF patients due to lack of sufficient donor 
organs and strict eligibility criteria, LVADs are increasingly being used to treat this 
patient population, and implantations exceeded heart transplants for the first time in 
2012.  
 
Whereas stage D HF can be the outcome of several etiologies of cardiac disease, it is 
characterized by excessive hemodynamic demands on the left ventricle that include 
further adverse remodeling. On a molecular level, this results in dysfunction in several 
interconnected biological pathways that promote disease progression (Figure 1) (1). 
Biomarkers representative of these processes are readily testable and reflect the degree 
of myocardial stress, fibrosis, fluid homeostasis, renal, and metabolomic dysfunction 
present in HF. Although less dramatic than cardiac replacement, LVAD therapy can 
restore normal cardiac hemodynamics and potentially lead to normalization of molecular 
measures of HF. However, few studies have comprehensively measured changes in HF 
biomarkers and metabolites in patients after LVAD support.  
 
There are numerous reasons for improved understanding of molecular changes with 
LVAD placement in patients with HF; these include understanding risk factors for stroke, 
infection, bleeding, optimization of VAD interactions with the cardiovascular system, and 
the potential for myocardial recovery. Thus far, few studies have managed to study the 
molecular effect of LVAD support, leading to inadequate information about the biological 
interactions between the support device and the patient with advanced HF. This has 
likely hampered the development of better devices and the better management of 
current devices.  
 
 

 
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1. Ahmad T, Fiuzat M, Felker GM, O'Connor C: Novel biomarkers in 
chronic heart failure. Nat Rev Cardiol 2012;9:347-59. 
Figure 1 – Stage D HF Results in Dysfunction in Several Interconnected Biological 
Pathways that Promote Disease Progression (1) 
 
 
 
 
3 
SUBSTUDY DESIGN 
The proposed research will aim to address current gaps in knowledge in regards to 
molecular changes with LVAD placement by creating a biobank of blood and urine 
samples from a subset of subjects enrolled in the MOMENTUM 3 CAP. The 
MOMENTUM 3 CAP is a prospective, multicenter, single-arm, continuation of the 
MOMENTUM 3 IDE clinical trial. The long-term aim of this study is to assess 
longitudinally blood and urine biomarkers in subjects with stage D HF who are 
undergoing implantation of LVADs. This study design will allow for an exploration of the 
levels and variability of known biomarkers at different stages of mechanical circulatory 
support and allow for the discovery of novel markers in the future. This collection for 
future medical research is intended to expand the translational R&D capability of the 
Sponsor and will support future research aims that will advance our understanding of 
advanced HF and options for treatment.  
4 
STUDY COURSE AND DURATION 
Enrollment in the MOMENTUM 3 Biobank is complete with 200 subjects. As shown 
below (Figure 2), subjects will have urine and blood samples drawn at key time-points 
that correlate with study visits to minimize hardship for the subject. Subjects will 
participate in the MOMENTUM 3 Biobank until completion of the day 180 follow up visit, 
until MOMENTUM 3 CAP outcome, or until the subject withdraws from the substudy.   

 
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Figure 2 – Study Flow - Blood (both plasma and serum) and urine samples will be 
collected to coincide with data obtained as part of the MOMENTUM 3 CAP. 
 
 
 
5 
STUDY POPULATION 
The study population is a subset of the population that enrolled in the MOMENTUM 3 
CAP who elect to participate in the MOMENTUM 3 Biobank. All sites participating in the 
MOMENTUM 3 CAP may be able to enroll subjects. Patients who do not receive the HM 
3 implant or are not enrolled in the MOMENTUM 3 CAP will be withdrawn from the 
Biobank and their baseline samples will be discarded. 
 
5.1 
Inclusion Criteria 
1. Subject or legally authorized representative has signed the Informed Consented 
Form (ICF) for the MOMENTUM 3 CAP  
2. Subject or legally authorized representative has signed the ICF for the MOMENTUM 
3 Biobank 
5.2 
Exclusion Criteria 
1. Inability to have pre-operative blood draw performed 
6 
OBJECTIVES 
6.1 
Primary Objective 
To establish a biobank of blood and urine samples at various time points pre- and post 
LVAD placement, which can be used for future assessment of CV specific biomarkers 
including potential analyses of coagulation system, HF biomarkers, etc.. 
6.2 
Exploratory Objectives 
• 
To correlate biomarkers with echocardiographic parameters 
• 
To find relationships between CV biomarkers and risk of thrombosis/bleeding 
• 
To find relationships between CV biomarkers and hospitalization/death 
 

 
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7 
RISKS 
The current study is without intended or anticipated medical benefit for the participating 
subjects, but will contribute to a better understanding of biomarkers in different LVAD 
populations. No investigational drug will be tested during this study. This study requires 
participation in the MOMENTUM 3 CAP.  
 
Risks from the phlebotomy procedures include infection, bleeding, localized bruising, 
blood clot formation, and discomfort at the venipuncture site. The total blood draw 
volume, at each time point, will be 29 ml in addition to the blood draw volume 
requirements of the MOMENTUM 3 CAP. The blood draws associated with this protocol 
may be performed in tandem with blood draws associated with the MOMENTUM CAP, 
further reducing incremental risks. 
8 
ETHICAL CONSIDERATIONS 
8.1 
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 must 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 the Sponsor.  
 
The process of obtaining Informed consent must be documented in each subject’s 
medical record. 
8.2 
IRB Review 
Investigators will conduct the study in compliance with the Declaration of Helsinki and 
local and national regulatory requirements.  
 
The Sponsor will comply with all IRB 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 the Sponsor for approval, prior to 
submitting to the IRB. Copies of the IRB submission and approval, including the 
approved ICF, must be forwarded to the Sponsor prior to the enrollment of subjects into 
the study. Sites will submit study progress reports in writing to the Sponsor and the IRB 

 
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as required. Sites will submit to the 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 the Sponsor and maintained on file at the study site. 
8.3 
Confidentiality 
No individually identifiable/confidential subject data collected as part of this study will be 
released beyond the Sponsor. 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 
security number, and medical record number, should be redacted by the site prior to 
submission to the Sponsor.  
 
Investigators will conduct the study in compliance with the Declaration of Helsinki and 
local and national regulatory requirements. 
 
The Sponsor will comply with all IRB 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 the Sponsor for approval, prior to 
submitting to the IRB. Copies of the IRB submission and approval, including the 
approved ICF, must be forwarded to the Sponsor prior to the enrollment of subjects into 
the study. Sites will submit study progress reports in writing to the Sponsor and the IRB 
as required. Sites will submit to the 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 the Sponsor and maintained on file at the study site. 
9 
BIOBANK SAMPLES  
The current biostorage plan calls for 5 aliquots of serum, 10 aliquots of plasma (5 EDTA, 
5 citrate) and 5 aliquots of urine.  Each aliquot will be at least 1 ml, and up to 1.5 ml.  
9.1 
Optimization of Samples 
For any given sample type there will be a range of possibility with respect to how many 
biomarkers can be run. Sample volumes required for different a single biomarker will 
vary from ~10 ul to up to ~250 depending on the platform utilized. For multiplex 
biomarker panels, up to 10 markers can be run simultaneously on 10-25 ul on a Meso 
Scale Discovery platform. If standard ELISA kits are used, sample volume is generally in 
the range of 50 ul and up to100 ul, and this is obligatorily a single biomarker.  If 
biomarkers are run on an FDA approved commercially available autoanalyzer (i.e., NT-
proBNP on a Roche Elecsys), generally, 250ul is required due to the dead space volume 
in the machine.   
 
Sample quality will decrease with each additional freeze thaw cycle (this is particularly 
true with sodium citrate plasma samples). Thus the scientific quality of the data will 
decrease if simple thaw, test, re-freeze is the strategy employed (i.e. 4 autoanalyzer 
runs would be possible but depending on the markers number 2, 3, 4 will have declining 
value).  However, with good planning this can be avoided: For example, if a plan is made 
for 30 novel protein markers on 4 multiplex chips, 5 markers by standard ELISA, 2 

 
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markers sent for auto analyzer runs simultaneously then a 1 ml cryovials of sample 
could support 37 individual biomarkers with 200ul for additional assays or future storage. 
Thus depending on the strategy employed to utilize the samples, each sample type with 
the current biobanking strategy of 5 aliquots could support as few as 5 biomarkers or as 
many as >250 biomarkers.  
9.2 
Potential Biomarkers 
DNA will not be collected as part of this study. Blood and urine will be drawn at the pre-
specified times for the measurement of blood and urine markers of coagulation 
dysfunction, fibrosis, inflammation, and endothelial dysfunction likely including but not 
limited to: 
 
 
• 
NT-pro-BNP 
• 
NP-proANP, 
• 
NTproCNP 
• 
Troponin T 
• 
hs-cTnT 
• 
Thrombomodulin 
• 
hs-CRP 
• 
ST2 
• 
MR-proADM 
• 
Copeptin 
• 
GDF-15 
• 
P-selectin 
• 
PAI-1 
• 
sST2 
• 
IF-ɣ 
• 
IL-1 
• 
IL-1ra 
• 
IL-2 
• 
IL-3 
• 
IL-4 
• 
IL-5 
 
• 
IL-6 
• 
IL-7 
• 
IL-8 
• 
IL-10 
• 
IL-17 
• 
IL-18 
• 
TNF 
• 
TGF 
• 
CRP 
• 
KIM-1 
• 
Cystatin-C 
• 
Osteopontin 
• 
Adiponectin 
• 
TNFR1 
• 
NFR2 
• 
sVCAM-1 
• 
Eotaxin 
• 
sICAM-1 
• 
FABP 
• 
MMP-12 
• 
MMP-32 
 
• 
MMP-3 
• 
MMP-7 
• 
MMP-8 
• 
MMP-9 
• 
FABP 
• 
FAS 
• 
VEGF 
• 
VEGFR1 
• 
Galectin-3 
• 
tPA 
• 
vWF 
• 
TIE-2 
• 
uPA 
• 
Osteoprotegerin 
• 
YKL-40 
• 
MPO 
• 
Thrombospondin-1 
• 
Eotaxin 
• 
Endoglin 
• 
Endothelian-1 
• 
Endostatin 
 
• 
Renin 
• 
sFLt- 1 
• 
Kallikrein-5 
• 
Tenscin C 
• 
TIMP-1 
• 
FGF-21 
• 
FGF-23 
• 
TIMP-3 
• 
syndecan-1 
• 
syndecan -4 
• 
TIMP-4 
• 
Angiotensin 
II 
• 
Uric acid 
• 
LDH 
• 
PIIINP 
• 
PICP 
• 
CITP 
• 
NGAL 
• 
Creatinine 
• 
Albumin 
• 
Metabolites  
 
 
 
 

 
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APPENDIX A: PLASMA & SERUM SAMPLE COLLECTION, 
PROCESSING, AND SHIPPING PROCEDURE 
 
 
 
 
Timing of Sample Collection and Types of Samples Collected 
Samples will be collected from subjects at four time-points: day 0 (baseline), day 7, day 30, day 
180) 
Samples collected at each time-point will include 29cc whole blood and 10cc urine. Samples will 
be collected as follows: 
1. Whole blood (a total of 29cc) will be collected into each of the following containers: 
a. One 10cc purple top tube with EDTA additive* 
b. Two 4.5cc blue top tubes containing sodium citrate additive* 
c. One 10cc red top tube with no additive* 
*Sites may use different volume and amounts of tubes as long as the total plasma/serum 
sample to be banked remains the same. 
2. 10cc of urine will be collected into a screw-top urine container. 
 
Preparation of Freezer Boxes 
Batches of freezer box kits will be provided to each study site. A kit consists of: 
1. Freezer box with label indicating subject number and time-point 
2. Cryovials 
3. Pre-printed strip of barcoded labels 
There will be labels on the sides of the box indicating the specimen type that goes in each row. 
The labels corresponding to specimen type and aliquot number (column) should be applied to 
the supplied cryovials. For example, a label that indicates “Urine” and specimen number 
12460.3 should be placed in the “Urine” row, in column #3. 
 
It is important to label cryovials BEFORE samples are collected, as when they are applied to 
frozen tubes, they often fall off, resulting in useless samples that must be discarded. If not all 
vials are filled for a given sample type, empty vials should be left in the box and returned to the 
central laboratory when the box with frozen samples is shipped back. 
 
Blood Collection Procedure 
Venipuncture technique: 
1. Draw blood using a butterfly needle.  
2. Ensure that each tube is filled completely. 
3. Fill tubes in the proper order to ensure that additives do not cross-contaminate: 
• 
Purple top tube (One tube) 
• 
Blue top tube (Two tubes) 
• 
Red top tube (One tube)  
4. Invert the purple and blue tubes with several gentle inversions to ensure proper mixing of 
additives.  
Blood can also be collected from a central line. An initial discard of 5 mL of blood from the line 
should be performed prior to collecting blood for research. Blood should be collected using new, 
clean syringes (one for the blue and purple tubes, and one for the red tube) using the order of 
draw and mixing protocols indicated above.  
 

 
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Blood Specimen Processing Procedure 
Red top tubes should be stored upright at room temperature until clotting is observed. Purple 
and blue top tubes should be stored upright in a refrigerator for up to 1 hour after collection. 
Samples should be processed as quickly as possible after collection. Importantly, purple and 
blue tubes can be processed even before the red top tube has clotted.  
1. Place blood collection tubes with rubber stoppers directly into centrifuge. Use bucket lids. 
2. Centrifuge at 1000g x 10 min, ideally at 4°C. 
3. For each sample type to be obtained, transfer only the clear liquid on top of the cell layer 
into the cryovials. Do not transfer any cells into the cryovials. If more than the required 
volume (5 mL) of clear liquid (serum or plasma) is present for any of the three blood 
sample types, the extra should be pipetted into the cryovials rather than thrown out. When 
pipetting extra, pipet up to 0.5 mL into each cryovial, starting from the last cryovial (vial 
#5). 
4. While pipetting the plasma, place the spun serum tube on ice for 10 
minutes in order to enhance clot retraction and maximize the amount of 
serum retrieved. 
5. Using a micropipette, transfer 1 mL of plasma from the purple tube into 
each of five 1.5 mL cryovials labeled PlasmaP. Change the micropipette 
tip between sample types.  
6. Using a micropipette, transfer 1 mL of plasma from the blue tube into each 
of five 1.5 mL cryovials labeled PlasmaB. Change the micropipette tip 
between sample types. 
7. Using a micropipette, transfer 1 mL of serum from the red tube into each of 
five 1.5 mL cryovials labeled Serum. If fibrin clots cause difficulty pipetting 
the serum, there are two methods that can be used: 
a. (Preferred) Remove fibrin clot using wooden sticks and then pipet the serum into the 
cryovials. 
b. If no wooden sticks are available, the supernatant can be decanted and then re-spun.  
Never re-centrifuge a tube that contains cells. 
8. Screw caps of cryovials onto aliquots and freeze the samples. Cryovials should be 
distributed in the box according to the box map. 
9. Specimens should be stored at -80 degrees C until shipped to the central lab. If this is not 
possible, temporary storage at -20 degrees C is acceptable. 
 
Urine Collection Procedure 
Subject should be instructed to urinate into a clean disposable urinal (if male) or a hat (if 
female). 10cc of this urine should be poured into the “spot” screw-top urine container. Urine 
mixed with stool is not acceptable for specimen collection. If the subject has an indwelling 
urinary catheter, a sample can be obtained from the catheter reservoir. 
 
Urine Specimen Processing Procedure 
Urine specimens should be stored on ice or in a refrigerator until ready to be processed; they 
should be processed as quickly as possible after collection. 
1. Transfer 6 mL of urine into a conical centrifuge tube using a transfer pipet. 
2. Centrifuge at 1000g x 10 min, ideally at 4 degrees C. 
3. Using a micropipette, transfer 1.5 mL of urine into each of five 1.5mL cryovials labeled 
Urine. Do not disturb the pellet at the bottom of the centrifuge tube.  
4. Cryovial caps should be screwed on tightly. Cryovials should be distributed in the box 
according to the box map. 

 
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5. Specimens should be stored at -80 degrees C until shipped to the central lab. If this is not 
possible, temporary storage at -20 degrees C is acceptable. 
 
 
Specimen Retention at the Core Lab 
Frozen specimens will be maintained at -80 degrees C at the central laboratory until all testing 
has been completed and the results analyzed to determine no re-testing of samples is required.  
Sample volumes remaining after the full battery of testing covered in this protocol is completed 
may be retained (at the central laboratory or at another location), discarded, or used for 
additional testing at the discretion of the study sponsor.