A Multi Center, Post Approval Study Providing Continued Evaluation and Follow-up on Patients Who Received a HeartWare® Ventricular Assist System During IDE Trials for the Treatment of Advanced Heart Failure
Conditions: Heart Failure
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

HeartWare® Ventricular Assist System (VAS) 
 
Post Approval Study 
HW-PAS-03 
 
IDE Follow-up Cohort 
Ver 3.0 
 
 
 
 
CONFIDENTIAL 
04 September 2013 
 
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Post Approval Study 
 
A Multi Center, Post Approval Study  
Providing Continued Evaluation and Follow-up on Patients  
Who Received a HeartWare® Ventricular Assist System During IDE Trials 
for the Treatment of Advanced Heart Failure  
 
 
 
 
 
 
 
 
 
 
 
Investigational Product: 
HeartWare® Ventricular Assist System  
Post Approval Study Number: 
HW-PAS-03  
Date: 
04 September, 2013 
 
 
 
This post approval study contains confidential information for use by investigators and their 
designated representatives participating in this clinical investigation.  It should be held 
confidential and maintained in a secure location. It should not be copied or made available for 
review by any person or firm without the prior written consent of HeartWare, Inc. 

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1.0 
Administrative Information 
1.1 
Contacts 
Medical, Clinical and Operational Support 
Sponsor Name: 
HeartWare, Inc. 
Sponsors Responsible Medical Officer  
David Hathaway, MD, Chief Medical Officer 
Sponsor Telephone Number 
+1 508 739 0950 
Sponsor Fax Number 
+1 508 739 0948 
Manufacturer and Sponsor Address: 
14000 NW 57th Ct 
 
Miami Lakes, FL 33014 
 
USA 
 
1.2 
Administrative Information 
Post Approval Study Number:  
HW-PAS-03 
Revision Number: 
3.0 
Protocol Date: 
04 September 2013 
Product: 
HeartWare® Ventricular Assist System (VAS)  
 
1.3 
Amendment History:  
Date  
Amendment Number 
Amendment Type  
20 September 
2012 
1.0 
Original Protocol 
31 May 2013 
2.0 
Revised Submission 
04 September 
2013 
3.0 
Revised Submission 
 
 

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1.4 
Sponsor Approval  
Representatives of HeartWare 
This study will be conducted with the highest respect for the individual participants in 
accordance with the requirements of this Post Approval Study and all applicable local laws and 
regulations, including, without limitation, data privacy laws and regulations. 
SIGNATURES 
Sponsor 
Signatory: 
Signature: 
 
Date: 
 
 
 
 
Name & Title David R. Hathaway, M.D.,  
Chief Medical Officer 
 
 
 
 
 
Name & Title Kevin Najarian, M.S.,  
Director Biostatistics and Data Management 
 
 
 
 
 
Name & Title Maritza Celaya,  
Senior Director of Regulatory Affairs 
 
 
 
 
 
 
Name & Title M. Steve Bell,  
Senior Director Clinical Project Management 
 
 
 
 
 
Name & Title Douglas Godshall,  
Chief Executive Officer 
 
 

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1.5 
Investigator agreement 
I will provide copies of the Post Approval Study and all pertinent information to all individuals 
responsible to me who assist in the conduct of the study.  I will discuss this material with them to 
ensure they are fully informed regarding the investigational products and the conduct of the 
study.  
I will use only the informed consent form approved by the sponsor and the Institutional Review 
Board/Independent Ethics Committee (IRB) or its representative.  
I also understand that this study will not be initiated without approval of the appropriate 
Institutional Review Committee and that all administrative requirements of the governing body 
of the institution will be complied with fully.  
I will obtain written informed consent from all participating subjects in accordance with 
requirements as specified in ICH Guideline for Good Clinical Practice; Section 48 (ICH GCP). 
I also agree to report all information or data in accordance with the Post Approval Study and, in 
particular, I agree to report without unjustified delay, all Serious Adverse Events (SAEs) and 
Device Deficiencies (DDs) that could have led to a reportable event. 
I further agree that HeartWare and/or designee will have access to any original source documents 
from which electronic case report form (eCRF) information may have been generated.  
I also agree to have control over all clinical supplies provided by HeartWare and/or designee and 
collect, account and handle all clinical specimens in accordance with the Post Approval Study 
protocol. 
I further agree not to originate or use the name of HeartWare Inc. and/or HeartWare® Ventricular 
Assist System, or any of its employees, in any publicity, news release or other public 
announcement, written or oral, whether to the public, press or otherwise, relating to this Post 
Approval Study, to any amendment hereto, or to the performance hereunder, without the prior 
written consent of HeartWare Inc. 
I herewith declare that I agree with the Post Approval Study described in detail in this document 
and agree to conduct the Post Approval Study in accordance with this document and in 
compliance with Good Clinical Practice and all applicable regulatory requirements. 
Investigator Name (print) 
 
Investigator Signature 
 
 
Date 
 
Name of Facility 
 
Location of Facility (City)  
 

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Table of Contents 
1.0 
Administrative Information 
2 
1.1 
Contacts................................................................................................................ 2 
1.2 
Administrative Information ................................................................................. 2 
1.3 
Amendment History: ............................................................................................ 2 
1.4 
Sponsor Approval ................................................................................................ 3 
1.5 
Investigator agreement ......................................................................................... 4 
2.0 
STUDY SUMMARY 
8 
3.0 
Study Reference Information 
9 
3.1 
List of Standard Abbreviations ............................................................................ 9 
4.0 
INTRODUCTION 
11 
4.1 
Background and Rationale ................................................................................. 11 
4.2 
HeartWare® VAS ............................................................................................... 11 
4.3 
Previous Patient and Trial Experience ............................................................... 12 
4.3.1 
CE Mark Trial ..................................................................................... 12 
4.3.2 
US Bridge to Transplant Trial (ADVANCE) ..................................... 12 
4.4 
Indication for Use .............................................................................................. 14 
5.0 
Study Objectives and Endpoint Measures (Endpoints) 
14 
6.0 
Study Design 
15 
6.1 
Number of Clinical Sites .................................................................................... 15 
6.2 
Patient Population .............................................................................................. 16 
6.2.1 
Inclusion Criteria ................................................................................ 16 
6.2.2 
Exclusion Criteria ............................................................................... 16 
6.3 
Criteria for Discontinuation or Withdrawal of a Patient .................................... 16 
6.4 
Procedure for Discontinuation or Withdrawal of a Subject ............................... 16 
7.0 
Sample Size 
17 
8.0 
Study Endpoints 
17 
8.1 
Observational endpoints..................................................................................... 17 
 
 
9.0 
Study Course and Visits 
18 
9.1 
Informed Consent Procedure ............................................................................. 18 
9.2 
Visits and Assessments ...................................................................................... 18 
9.2.1 
Enrollment Visit for Patients Active on Device ................................. 18 
9.2.2 
Enrollment Visit for Patients not on Device ....................................... 19 
9.2.3 
6 Month Follow up Assessments for Patients Active on Device ........ 19 
9.2.4 
6 Month Follow-up Assessments for Patients not on Device ............. 20 

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9.2.5 
6 Month Follow-up Assessments for Patients who Exchange for 
Another Type of LVAD ..................................................................................... 20 
9.2.6 
Re-Hospitalizations ............................................................................. 20 
9.2.7 
Device Explant .................................................................................... 20 
9.2.8 
Outcomes ............................................................................................ 21 
10.0 
Procedures 
22 
10.1 
Demography ....................................................................................................... 22 
10.2 
General Hemodynamics ..................................................................................... 22 
10.3 
Documentation of Concomitant Medications .................................................... 22 
10.4 
Safety Laboratory Investigations ....................................................................... 22 
10.5 
HeartWare® Pump Parameters ........................................................................... 23 
10.6 
Exercise Function (Six Minute Walk) ............................................................... 23 
10.7 
NYHA classification .......................................................................................... 23 
10.8 
NIH Stroke Scale/ Modified Rankin Scale ........................................................ 23 
10.9 
Patient Device Strategy ...................................................................................... 24 
10.10 
Quality of life Questionnaire (EuroQol EQ-5D-5L) .......................................... 24 
10.11 
Kansas City Cardiomyopathy Questionnaire (KCCQ) ...................................... 24 
10.12 
Neurocognitive Testing ...................................................................................... 24 
11.0 
Adverse Events 
25 
11.1 
INTERMACS®-defined adverse events ............................................................. 25 
11.2 
Device Malfunctions .......................................................................................... 26 
11.3 
Definition of Adverse Event (AE) ..................................................................... 26 
11.4 
Definition of Serious Adverse Event (SAE) ...................................................... 26 
11.5 
Unanticipated Adverse Device Effects .............................................................. 26 
11.6 
Anticipated Adverse Events ............................................................................... 26 
11.7 
Adverse Event Reporting Requirements ............................................................ 27 
11.7.1 
UADE Reporting ................................................................................ 27 
12.0 
Device and Patient Management 
28 
12.1 
Infection Control ................................................................................................ 28 
12.2 
Anticoagulation Guidelines ............................................................................... 28 
12.3 
Return or Readmission to Hospital .................................................................... 28 
13.0 
Statistical Analysis 
29 
14.0 
Detailed study timelines 
29 
15.0 
Reporting Requirements (interim and final reports) 
30 
16.0 
Regulatory and Ethical Considerations 
30 
16.1 
IRB Approval ..................................................................................................... 30 
16.2 
Informed Consent............................................................................................... 30 
16.3 
Patient Data Protection ...................................................................................... 31 

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17.0 
Investigators, Investigator Responsibility and Trial Administrative Structure 
31 
17.1 
Investigator Agreement ...................................................................................... 31 
17.2 
Financial Disclosure ........................................................................................... 32 
17.3 
Post Approval Study Deviations and Medical Emergencies ............................. 32 
17.4 
HeartWare (Sponsor) ......................................................................................... 32 
17.5 
Contract Research Organization ........................................................................ 32 
18.0 
Documentation of Trial Data 
33 
18.1 
Case Report Forms ............................................................................................. 33 
18.2 
Data Management .............................................................................................. 33 
18.2.1 
eCRF ................................................................................................... 33 
18.2.2 
Coding ................................................................................................. 33 
18.2.3 
Source data .......................................................................................... 33 
18.2.4 
Data Review and Data Quality Assurance .......................................... 34 
19.0 
Data Monitoring and Administrative Requirements 
35 
19.1 
Monitoring of the Study ..................................................................................... 35 
19.2 
Quality System, Audit and inspection ............................................................... 35 
19.3 
Audit .................................................................................................................. 35 
19.4 
Inspection ........................................................................................................... 35 
19.5 
Maintenance of Study Documentation............................................................... 36 
19.6 
Protocol Modifications....................................................................................... 36 
19.7 
Compliance and Investigational Site Termination ............................................. 36 
19.7.1 
Compliance ......................................................................................... 36 
19.7.2 
Investigational Site Termination ......................................................... 37 
19.8 
Record Retention ............................................................................................... 37 
19.9 
Site Training....................................................................................................... 37 
19.10 
Confidentiality of trial results ............................................................................ 37 
19.11 
Publication policy .............................................................................................. 37 
19.12 
Final report ......................................................................................................... 38 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
21.0 
References 
58 
 

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2.0 
STUDY SUMMARY 
Name of Sponsor(s):  HeartWare Inc. 
Device: HeartWare® VAS is an implantable centrifugal blood pump, with the following major components: 
Implantable Blood Pump with Conduits, Controller, Monitor, Batteries, Battery Charger and Accessories 
Title of Post Approval Study:  
A Multi Center, Post Approval Study Providing Continued Evaluation and Follow-
up on Patients Who Received a HeartWare® Ventricular Assist System During IDE 
Trials for the Treatment of Advanced Heart Failure. 
 
Post Approval Study Number:   HW-PAS-03 
Post Approval Study Design:  Open label, observational, follow-on study. 
Endpoints:    Endpoints that will be assessed include: 
• 
Overall survival 
• 
Re-hospitalizations 
• 
Quality of Life improvement, as measured by KCCQ and EuroQol EQ-5D 
• 
Incidence of INTERMACS® adverse events and unanticipated adverse device effects. 
• 
Incidence of all device failures and device malfunctions 
• 
Functional status improvement, as measured by NYHA and 6-minute walk 
Intended Use:  The HeartWare® Ventricular Assist System (VAS) is intended for use as a bridge to cardiac 
transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The 
HeartWare® VAS is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing 
aircraft or helicopter. 
Number of Subjects:  Subjects from IDE G070199 that 
meet the criteria will be enrolled. 
Number of Sites:  Up to 25 
Period of Evaluation: 
All patients will have an enrollment visit and then be followed at 6 month intervals until 5 years post implant of 
the original HeartWare® device. 
Patients who are explanted for transplant or recovery will be followed to 6 months post explant at which point 
their participation in the trial will be considered complete. This visit will record patient status only. 
Main Criteria for Inclusion: 
1. The patient has participated in a prior HeartWare trial under IDE G070199. 
2. The patient was implanted with the HeartWare® VAS and was an active patient in the prior trial. 
3. The patient has signed informed consent for participation in the study. 
Main Criteria for Exclusion: 
1. The patient is unwilling or unable to comply with trial requirements. 
2. The patient did not sign the informed consent. 
Main Criteria for Evaluation and Analyses: 
Endpoints that will be assessed include; overall survival on device, final patient status, re-hospitalizations, 
INTERMACS® adverse events, Quality of Life measures, functional status.  Safety measures will include the 
frequency and rates of adverse events, overall and for each specific event, which will be collected throughout 
HeartWare® VAS support 
Sample Size Justification and Statistical Considerations:   
 Not Applicable as this is a follow-up study only and does not involve the screening and implant of new patients. 

HeartWare® Ventricular Assist System (VAS) 
 
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Ver 3.0 
 
 
 
 
CONFIDENTIAL 
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3.0 
Study Reference Information 
3.1 
List of Standard Abbreviations 
Abbreviation 
Definition 
ACE 
Angiotensin-converting enzyme 
AE 
Adverse Event 
ALT 
Alanine aminotransferase 
ARB 
Angiotensin Receptor Blocker 
AST 
Aspartate aminotransferase 
BP 
Blood Pressure 
BSA 
Body Surface Area (m2) 
BTT 
Bridge to Transplantation 
BUN 
Blood Urea Nitrogen 
CFR 
Code of Federal Regulations 
CK 
Creatine Kinase 
CNS 
Central Nervous System 
CRF 
Case Report Form 
CRO 
Clinical Research Organization 
CSS 
Clinical Summary Score of KCCQ 
CVA 
Cerebral Vascular Accident (stroke) 
CVP 
Central Venous Pressure 
eCRF 
Electronic Case Report Form 
ECG 
Electrocardiogram 
EQ-5D 
EuroQol Questionnaire (Health Status tool) 
FDA 
United States Food and Drug Administration 
GCP 
Good Clinical Practice 
HF 
Heart Failure 
Hgb 
Hemoglobin 
ICF 
Informed Consent Form  
IDE 
Investigational Device Exemption 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ICH 
International Conference on Harmonisation 
INR 
International Normalized Ratio 
INTERMACS® 
InterAgency Registry for Mechanical Assisted Circulatory Support 
ISHLT 
International Society for Heart & Lung Transplantation 
KCCQ  
Kansas City Cardiomyopathy Questionnaire ( tool) 
LED 
Light Emitting Diode 
LV 
Left Ventricle 

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Abbreviation 
Definition 
LVAD 
Left Ventricular Assist Device 
LVEF 
Left Ventricular Ejection Fraction 
Mb 
Myoglobin  
MCS 
Mechanical Circulatory Support 
MCSD 
Mechanical Circulatory Support Device 
MedDRA 
Medical Dictionary for Regulatory Activities 
mL 
milliliter 
MI 
Myocardial Infarction 
MRS 
Modified Rankin Scale 
NIH 
National Institutes of Health 
NIHSS 
National Institutes of Health Stroke Scale  
NYHA 
New York Heart Association (heart failure classification) 
PAS 
Post Approval Study 
PI 
Principal Investigator 
Pt / Pts 
Patient / Patients 
PMA 
Premarket Approval 
PTT 
Partial Thromboplastin Time (activated = aPTT) 
PVAD 
Paracorporeal Ventricular Assist Device 
PVR 
Pulmonary Vascular Resistance 
QoL 
Quality of Life 
RAP 
Right Arterial Pressure 
RGA 
Returned Goods Authorization 
RVAD 
Right Ventricular Assist Device 
RVEF 
Right Ventricular Ejection Fraction 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
SE 
Standard Error 
TE 
Thromboembolic Event 
TIA 
Transient Ischemic Attack 
TX 
Transplant 
UADE 
Unanticipated Adverse Device Effect 
UNOS 
United Network for Organ Sharing 
UCL 
Upper Confidence Limit 
VAD 
Ventricular Assist Device 
VAS 
Ventricular Assist System 
WBC 
White Blood Cell 

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4.0 
INTRODUCTION 
4.1 
Background and Rationale 
Heart Failure (HF) is a complex clinical syndrome caused by structural, metabolic and 
neurohormonal disorders that impair cardiovascular function, and is one of the leading causes of 
death in the developed world.   
The worldwide prevalence of heart failure in adults is estimated to be 2-6%, with a higher 
prevalence in industrialized nations.  Each year in the US, 670,000 new cases are identified1 and 
of the prevalent cases, 1 million are end-stage HF (NYHA class IV).  There are approximately 
5.7 million cases diagnosed in the United States and up to 14 million cases in the European 
Union2.  Advanced HF is associated with significant morbidity and disabling symptoms at rest.  
The one year mortality rate in patients newly diagnosed with NYHA class IV HF is 
approximately 25%3.  Improvements in treatment and survival as well as expansion of the aging 
population have contributed to the rising incidence and prevalence of the disease. 
Cardiac transplantation is currently the most effective therapy for advanced heart failure.  
However, the lack of available donor organs restricts the use of heart transplantation to fewer 
than 2500 patients per year in the United States.  In 2009, 2211 heart transplants were performed 
at 127 heart transplant centers in the United States (United Network for Organ Sharing website 
accessed December 15, 2011).  Currently there are 3100 patients on the UNOS heart transplant 
list, with an average waiting time of approximately 6 months 4.  
This Post Approval Study (PAS) is a study to provide continued and consistent follow-up on 
patients who have participated in prior IDE trials of HeartWare devices.  Eligible patients 
include those who have reached the primary endpoint or outcome of that trial and entered longer 
term follow-up, as well as, those who have not yet achieved the primary endpoint or outcome at 
the time of PMA approval. 
4.2 
HeartWare® VAS 
A full description of the HeartWare® VAS is included in the Instructions for Use (IFU) for the 
approved indications.   
Ventricular Assist Devices are options for advanced HF patients that sustain life, improve 
general medical condition and enhance quality of life as they provide a bridge to cardiac 
transplantation or, in some patients, an alternative permanent therapy.  Approximately 32% of 
the patients who receive heart transplants are bridged with ventricular assist devices (ISHLT 
2011 data 4).  The use of permanent LVADs as an alternative to transplantation (Destination 
Therapy) has also proven to be more effective than medical therapy. 5 
The HeartWare® VAS was designed to assist a failing left ventricle.  The HeartWare® VAS 
utilizes a blood pump, the HVAD® Pump or simply HVAD, which is a continuous flow, 
centrifugal device with a non-contacting rotating impeller and dual motor stators for compact 
size and increased fault tolerance.  The impeller is suspended by a combination of passive 
magnetic and hydrodynamic forces.  The inflow cannula is an integrated component permanently 

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affixed to the pump and is attached to the left ventricular apex through a c-clamp type sewing 
ring.  Blood is pumped from the left ventricle into  the ascending aorta via  a 10mm gel 
impregnated polyester conduit that can be adjusted to fit patient size and is protected from 
kinking or compression by a strain relief.  This design facilitates surgical implantation entirely 
within the pericardial space avoiding the necessity for an abdominal pump pocket and potentially 
reducing perioperative risks such as bleeding and infections.  While the HeartWare® VAS is 
small (160g), it can deliver up to 10 liters/minute of blood flow. 
A 4.2 mm diameter percutaneous driveline connects the pump to an external controller.  The 
controller, powered by two batteries or by one battery and electricity from the wall or car outlet, 
regulates pump function and provides digital messages, alarms and LED light patterns that alert 
patients to pump parameters that are outside pre-set limits or warn of malfunctions in the system.  
A separate monitor is used to display system performance and to change controller operating 
parameters.  A battery charger is also included.  
4.3 
Previous Patient and Trial Experience 
4.3.1 CE Mark Trial 
The initial clinical experience with the HeartWare® VAS was a 50 subject BTT trial conducted at 
5 centers in Australia, Austria, Germany and the United Kingdom.  The first 25 subjects were 
enrolled between March 2006 and December 2007 and the results were submitted for regulatory 
approval in the EU.  CE Mark was received on January 29, 2009.  The trial was continued to 
enroll another 25 patients for a total of fifty (50) patients, with the last patient enrolled in 
December 2008.   
The primary endpoint of survival to 180 days was successfully reached by 90% (45/50) of the 
patients.  
As of January 18, 2012, 29 of the 50 subjects were transplanted, four were weaned from the 
HeartWare® VAS due to myocardial recovery, 11 died while on support, and 6 subjects remain 
on support.  All 6 subjects currently supported by HeartWare® VAS have been on the device for 
more than 3 years, with 2 patients greater than 4 years.  
4.3.2 US Bridge to Transplant Trial (ADVANCE) 
The HW003 Evaluation of the HeartWare® VAS for the Treatment of Advanced Heart Failure 
Trial, or ADVANCE, was a multi-center, prospective trial that used an external 
contemporaneous control group from the NIH sponsored Inter-Agency Registry for Mechanical 
Assisted Circulatory Support (INTERMACS®) to compare the efficacy of HeartWare® VAS with 
commercially approved LVADs.  The INTERMACS® control subjects were not homogeneous 
with respect to the type of left ventricular assist device, although more than 90% of the subjects 
received the HeartMate II LVAD (Thoratec Corporation) which is the only approved continuous 
flow LVAD in the United States.  In both the HeartWare® VAS and INTERMACS® registry 
control group, subjects were followed to death, device explant, cardiac transplantation or 
survival to Day 180.   

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In ADVANCE there were 160 subjects enrolled at 30 sites.  Of the 160 subjects, 17 were screen 
failures and 143 subjects were implanted with the HeartWare® VAS.  Three of these 143 patients 
were implanted under emergency use treatment.  Of the remaining 140 patients implanted, 3 
patients were found to have protocol violations which were pre-specified in the statistical 
analysis plan (SAP) as major violations.  As a result, there were 137 subjects in the “per 
protocol” population and 140 subjects in the “safety” population.  The first subject was 
implanted on August 18, 2008 and the 180 day follow up for the last subject enrolled and 
implanted was completed August 23, 2010.   
The primary endpoint for the trial was defined as alive on the originally implanted device 
(HeartWare® VAS or LVAD in the registry control group), transplanted or explanted for 
recovery at the 180 day time point, all of which collectively constituted “success.” 
Secondary efficacy measures include overall survival, quality of life improvement, as measured 
by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQol EQ-5D™ - (EQ-5D) 
and functional status improvement.   
Secondary efficacy measures were based upon change from baseline in the HeartWare® VAS 
treatment group since registry data were not specified for comparison in the protocol.  
Safety endpoints consisted of the incidence of INTERMACS®-defined events, serious adverse 
events (SAE), including neurocognitive changes, unanticipated adverse device effects (UADE); 
and device failures and malfunctions.  Events were classified and presented according to both the 
INTERMACS®-defined adverse event categories and MedDRA coded categories.  Adverse 
events from the INTERMACS® control group were not pre-specified to be available for 
comparison. 
The pre-specified primary endpoint analysis was a comparison of success rates using a non-
inferiority margin of 15%.   
In the HeartWare® VAS group the success rate in the ITT / Safety Population at 180 days was 
90.7% (127/140) and in the Per Protocol population 92.0% (126/137).  The success for both 
Safety and Per Protocol populations in the Control group was 90.1% (448/497). 
The Primary analysis found that the 95% one-sided upper confidence limit (UCL) on the 
difference in success rates between HeartWare® VAS group and controls was 4.5% for the 
Safety population and 0.9% for the Per Protocol population.  Each of these limits was less than 
the 15% non-inferiority margin (p <0.0001). 
 
 

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4.4 
Indication for Use 
The HeartWare® VAS is intended for use as a bridge to cardiac transplantation in patients who 
are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare® VAS 
is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing 
aircraft or helicopter.  
The HeartWare® VAS is contraindicated in patients who cannot tolerate anticoagulation therapy. 
5.0 
Study Objectives and Endpoint Measures (Endpoints) 
The purpose of this multi-center, follow-up trial is to continue the evaluation of the safety and 
effectiveness of the HeartWare® VAS in patients who have been implanted with the HeartWare® 
VAS in the course of a prior HeartWare Trial under IDE G070199.   
Endpoints that will be assessed include: 
• Overall survival on device 
• Final patient status 
• Re-hospitalizations 
• INTERMACS® adverse events 
• Quality of Life measures 
• Functional Status 
 
Safety measures will include the frequency and rates of adverse events, overall and for each 
specific event, which will be collected throughout HeartWare® VAS support. 
 
 

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6.0 
Study Design 
No new patients are being screened or implanted with the HeartWare® VAS for this trial; it is a 
follow-up trial only.  
Patients will be approached to participate in this PAS after the HeartWare® VAS receives PMA 
approval for the indicated use as a bridge to cardiac transplantation.  
Patients who participated in a prior trial under IDE G070199 will be approached for this PAS as 
follows: 
• Patients who are on continued HeartWare® VAS support, (original or exchange device) 
• Patients who have been explanted for transplant or recovery and have not yet completed 6 
months of follow-up 
Patients who participated in prior trials under IDE G070199 who will not be approached to 
participate in this follow-up study include: 
• Patients who have been explanted for transplant or recovery and have completed at least 
6 months of follow-up (documented in the prior IDE trial). 
• Patients who have had their HeartWare® VAS exchanged for another FDA approved 
VAD (e.g. HMII®) 
 
All patients will have an enrollment visit and then be followed at 6 month intervals until 5 years 
post implant of the original HeartWare® VAS. 
Patients who are explanted for transplant or recovery will be followed to 6 months post explant 
at which point their participation in the trial will be considered complete.  This visit will record 
patient status only. 
6.1 
Number of Clinical Sites 
This follow-up trial will be conducted at up to the 25 sites who enrolled and implanted patients 
with the HeartWare® VAS under IDE G070199, and who have a patient active under that IDE at 
the time of approval.   
 
 

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6.2 
Patient Population 
The patient population consists of patients who were at risk of death from refractory, advanced 
heart failure and implanted with a HeartWare® VAS under IDE G070199.  
Patients must have participated as a study patient in a prior HeartWare trial under IDE G070199, 
and been implanted with the HeartWare® VAS.  The following inclusion and exclusion criteria 
must then be applied: 
6.2.1 Inclusion Criteria 
1. The patient has participated in a prior HeartWare trial under IDE G070199. 
2. The patient was implanted with the HeartWare® VAS and was an active patient in the 
prior trial. 
3. The patient has signed informed consent for participation in the study. 
6.2.2 Exclusion Criteria 
1. The patient is unwilling or unable to comply with trial requirements. 
2. The patient did not sign the informed consent. 
6.3 
Criteria for Discontinuation or Withdrawal of a Patient 
The primary reason for discontinuation or withdrawal of the patient from the study should be 
noted using the following categories.  
1. Lost to follow-up.  The patient did not return to the clinic and attempts to contact the 
patient were unsuccessful.  Attempts to contact the patient must be documented. 
2. Voluntary withdrawal.  The patient wishes to withdraw from the study.  The reason for 
withdrawal, if provided, should be recorded in the eCRF.  NOTE:  All attempts should be 
made to determine the underlying reason for the withdrawal and, where possible, the 
primary underlying reason should be recorded). 
3. Study termination.  The sponsor, Institutional Review Board (IRB), or regulatory agency 
terminates the study. 
4. Other. NOTE:  The specific reasons, or, if a patient refuses to give a reason, should be 
recorded accordingly in the eCRF. 
6.4 
  Procedure for Discontinuation or Withdrawal of a Subject 
A patient may discontinue his or her participation without giving a reason at any time during the 
study.  Should a subject’s participation be discontinued, the primary reason for termination must 
be recorded in the eCRF.  Efforts should be made to perform all procedures scheduled for the 
Year 5 visit.   
 
 

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7.0 
Sample Size 
Sample size calculations are not applicable for this observational follow-on trial. 
8.0 
Study Endpoints 
This is a follow-on study and endpoints are observational only. 
8.1 
Observational endpoints 
Observational endpoints for this trial include: 
• Overall survival on device 
• Final patient status 
• Re-hospitalizations 
• INTERMACS® adverse events 
• Quality of Life measures 
• Functional Status  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 

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9.0 
Study Course and Visits 
The following sections describe the procedures to be completed throughout the conduct of the 
study.  The Schedule of Study Procedures is described in this section 
 
.  Every attempt should be made to perform evaluations at the designated time points. For 
visits conducted every 6 months post implant, there is a window of ± 60days. 
Post IRB Approval of this study, patients will be consented to participate at their next visit for 
the IDE trial, which will be considered their final visit.  At that visit their participation in the IDE 
trial will be halted and they will be provided information about this PAS, and if they give written 
informed consent to participate they will be considered enrolled in this PAS. 
9.1 
Informed Consent Procedure 
Before enrolling the patient in the trial, i.e., any trial-related procedure is performed; written ICF 
must be obtained.  Each potential participant shall be informed of the aim of the trial and what 
participation entails.  They shall be supplied with an Information Sheet summarizing the details 
of the trial.  Ample time should be given to the subjects to consider their participation.  
Agreement to participate in the trial is to be confirmed by the patient and the Principal 
Investigator (or authorized designee) signing and dating the consent form.  Documentation of 
this procedure is required in the medical record. 
9.2 
Visits and Assessments 
Assessments will be conducted at enrollment and at follow-up visits. Patients active on device 
will have follow-up visits every 6 months until outcome or 5 years post implant of the original 
device.  There will be additional assessments if patients reach an outcome i.e., are re-
hospitalized, have the device explanted or replaced, and in the event of a patient death.   
Study visits and assessment are described as follows: 
9.2.1 Enrollment Visit for Patients Active on Device 
The following procedures will be performed:  
• Obtain signed and dated written ICF 
• Inclusion/Exclusion 
• Date of Assessment 
• Record Demographics 
• Measure Hemodynamic parameters 
• Collect blood samples for laboratory testing 
• Record LVAD Parameters 
• Perform NYHA Classification 
• Perform 6- Minute Walk Test 
• Record patient status 
• Patient device strategy 

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• NIH Stroke Scale/Modified Rankin Scale 
• Collect Neurocognitive function data 
• Collect Kansas City Cardiomyopathy Questionnaire 
• Collect Quality of life questionnaire (EuroQol EQ-5D-5L) 
• Record concomitant medication taken by the patient 
• Document adverse events reported from date of signature of the ICF including 
ongoing adverse events from the premarket trial 
 
If an enrollment visit occurs within the protocol allowed window for a 6 month follow-up visit, 
then the enrollment visit takes the place of that 6 month follow-up visit.  The patient then 
resumes their follow up schedule based upon their original implant date.     
Additionally the patient identifier from the prior trial and the trial ID will be captured.  
9.2.2 Enrollment Visit for Patients not on Device 
• For patients who have been explanted for transplant or recovery in the prior IDE trial, 
and have not completed 6 months post explant follow up the following procedures 
will be performed:Obtain signed and dated written ICF 
• Date of Assessment 
• Record patient status 
 
Additionally the patient identifier from the prior trial and the trial ID will be captured. 
9.2.3 6 Month Follow up Assessments for Patients Active on Device 
The following procedures will be performed: 
• Date of Assessment 
• Measure Hemodynamic parameters 
• Collect blood samples for laboratory testing 
• Record LVAD Parameters 
• Perform NYHA Classification 
• Perform 6- Minute Walk Test 
• Record patient status 
• Patient device strategy  
• NIH Stroke Score/Modified Rankin Scale 
• Collect Neurocognitive function data 
• Collect Kansas City Cardiomyopathy Questionnaire 
• Collect  Quality of life questionnaire (EuroQol EQ-5D-5L) 
• Record concomitant medication taken by the subject 
• Document adverse events reported 
 
 

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9.2.4 6 Month Follow-up Assessments for Patients not on Device 
For patients who have been explanted for transplant or recovery (or device turned off in lieu of 
surgical explant), the following data will be collected at 6 months post explant only:  
• Date of Assessment 
• Record patient status 
 
After the 6 month follow up visit the patient’s participation in the study will be complete.  
9.2.5 6 Month Follow-up Assessments for Patients who Exchange for Another Type of 
LVAD 
For patients who have had their HeartWare® VAS exchanged to another FDA approved VAD 
(e.g. HMII®) the following data will be collected at 6 months post exchange only: 
• Date of Assessment 
• Record patient status  
 
After the 6 month post exchange follow up visit the patient’s participation in the study will 
be complete. 
9.2.6 Re-Hospitalizations 
Information on re-hospitalizations post initial discharge will be collected.  This includes date and 
reason for readmission, treatment and date of discharge. 
9.2.7 Device Explant 
In the event that the HeartWare® VAS is explanted (i.e. death, transplant, recovery, device 
exchange) observations should be documented in the eCRF. 
The rationale for explant of the HeartWare® VAS will be recorded on the eCRF.   
Reasons may include:  
• Heart Recovery 
• Heart Transplantation 
• HeartWare® VAS Exchange 
• Mortality or 
• Alternative Device Implant 
At explant, the HeartWare® VAS and the incision sites should be inspected for: 
• Pump condition prior to explant, 
• Pericardial or pump pocket condition, 
• Sewing Ring condition, 
• Outflow Conduit condition and position, 
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• Blood pump housing condition.  
Any identified unusual findings are to be reported on the eCRF. 
The HeartWare® VAS should NOT be disassembled by the center.  See the IFU for the approved 
Indication for the HeartWare® VAS Explant procedure. 
The HeartWare® VAS components shall be returned to HeartWare  in all cases in which the 
device/component is suspected to have malfunctioned or it is replaced for any reason as the 
result of an adverse event. 
For HeartWare® VAS devices that need to be returned, HeartWare will provide an Explant Kit 
that is designed for transportation of used health care products.  Packaging instructions will be 
included in each Explant Kit.   
An Explant Kit is available by contacting HeartWare Customer Support at 1-(305)-364-2500 or 
email cs@heartwareinc.com. 
9.2.8 Outcomes 
Information on the type of outcome (transplant, explant, death) will include transplant date, 
reason for explant, and cause of death.  Patients who have been transplanted or have been 
explanted will be followed until 6 months post outcome.  

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10.0 
Procedures 
The following are a description of the procedures that will be conducted during patient visits. 
10.1 Demography 
The standard demographics of age, date of birth, gender, height, weight, race, and patient-
described ethnicity will be recorded during enrollment visit only. 
10.2 General Hemodynamics 
General hemodynamics to be collected are: 
• Heart rate 
• Blood pressure (Systolic/Diastolic and Mean) 
10.3 Documentation of Concomitant Medications 
All cardiac medications including inotropes, nesirtide, angiotensin receptor blockers, 
amiodarones, beta blockers, ACE inhibitors, aldosterone antagonists, loop diuretics, 
anticoagulants, antiplatelet therapy drugs and nitric oxide will be captured at Enrollment and 
every 6 months until year 5 post-implant or study discontinuation (whichever comes first). 
Any Concomitant Medications taken prior, up to onset and to treat an Adverse Event will be 
collected at the time of each event, including any specific medications pertaining to the 
anticoagulation guidelines for thromboembolism, stroke and / or VAD thrombosis.    
10.4 Safety Laboratory Investigations 
Laboratory samples will be taken for all patients active on device at enrollment and at every 
follow-up visit (every 6 months until year 5 post-implant or study discontinuation whichever 
comes first).  
The laboratory variables that will be determined are listed below: 
Hematology 
White Blood Cell Count 
Platelet 
Hemoglobin 
INR 
 
Biochemistry 
Sodium 
LDH 
Potassium 
Total Bilirubin 
Blood Urea Nitrogen 
Bilirubin direct and Indirect 
Creatinine 
Albumin 
SGPT/ALT 
Cholesterol 
SGOT/AST 
 

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10.5 HeartWare® Pump Parameters 
LVAD parameters of Flow (L/min), Speed (RPM) and Power (Watts),  along with 
documentation of suction detection status and status of alarm reporting will be recorded at 
enrollment and every 6 months until year 5 post-implant or study discontinuation (whichever 
comes first). 
10.6 Exercise Function (Six Minute Walk) 
Assessment of exercise function consists of a six minute walk test and will be completed at 
enrollment and every 6 months until year 5 post-implant or study discontinuation (whichever 
comes first). 
All efforts should be made to perform the 6 minute walk test for any patient able to walk more 
than a few steps.  If the patient is unable or unwilling to perform the six-minute walk test, the 
result will be recorded as not done.  If the six minute walk test was not completed the reason will 
be recorded.  
 
10.7 NYHA classification 
  Determination of NYHA 
classification will be performed by an independent assessor (defined as a physician or qualified 
physician assistant (PA), registered nurse (RN) or nurse practitioner (NP) not directly involved 
with this clinical trial).  The name of the assessor will be recorded on the Case Report Form and 
in the medical files. 
NYHA will be captured for all patients at enrollment and every follow up visit (every 6 months 
until year 5 post-implant or study discontinuation, whichever comes first) 
10.8 NIH Stroke Scale/ Modified Rankin Scale 
For patients active on device, a trained individual will obtain the National Institutes of Health 
Stroke Scale (NIHSS) and Modified Rankin Scale (MRS), 
 at the 
enrollment visit and every follow up visit (every 6 months until year 5 post-implant or study 
discontinuation, whichever comes first) 
In addition, the NIH Stroke Scale and MRS are required in the event of a stroke.  After a stroke, 
follow-up NIH Stroke Scale and MRS are captured at each 6 month follow up visit. 
 
 

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10.9 Patient Device Strategy 
Current Device Strategy determined in conjunction with the heart failure cardiologist and 
surgeon at the time of the implant should be re-visited and recorded at enrollment and every 
follow up visit (every 6 months until year 5 post-implant or study discontinuation, whichever 
comes first) 
The strategy should be selected as: 
 
• Bridge to recovery 
• Bridge to transplant 
• Possible bridge to transplant  
• Destination therapy 
 
If the patient device strategy has changed from the prior visit, the reason for the change in device 
strategy will be recorded in the eCRF. 
10.10 Quality of life Questionnaire (EuroQol EQ-5D-5L) 
The EQ-5D-5L 
; an assessment of general well-being will be utilized.  
Assessment will be performed for patients at enrollment and every follow up visit (every 6 
months until year 5 post-implant or study discontinuation, whichever comes first) 
10.11 Kansas City Cardiomyopathy Questionnaire (KCCQ) 
This study will use the KCCQ
, a disease specific 23-item, self-
administered instrument that quantifies physical function, symptoms (frequency, severity and 
recent change), social function, self-efficacy and knowledge and quality of life.  Patients will 
complete the KCCQ at enrollment and every follow up visit (every 6 months until year 5 post-
implant or study discontinuation, whichever comes first) 
10.12 Neurocognitive Testing 
Neurocognitive function data 
 will be measured by the Trial Making 
Neurocognitive Test, Part B at enrollment and every follow up visit (every 6 months until year 5 
post-implant or study discontinuation, whichever comes first).  This test of general cognitive 
function also specifically assesses working memory, visual processing, visuospatial skills, 
selective and divided attention and psychomotor coordination for the Neurocognitive Function 
Test) 
 

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11.0 
Adverse Events 
Adverse events collected will be captured and categorized according to NIH funded 
INTERMACS® registry defined adverse events, and this will also include any serious and/or  
non-serious AEs not meeting the INTERMACS® definitions that are noted to be clinically 
relevant by the PI.  These will be recorded on the appropriate eCRF. 
Adverse events will be collected throughout the subject’s participation in this follow-up trial 
while on device support, and the subject instructed to report any event to the investigator when 
and /or as it occurs. 
In the event of an explant for transplant or recovery, adverse events will be collected until the 
induction of anesthesia for explant. 
In the event the device is turned off in lieu of surgical explant, adverse events will be collected 
until the time the device is turned off.  
In the event of an explant for an exchange for another HeartWare® VAS, the subject will remain 
in the study post device exchange and adverse events will be collected throughout the subject’s 
participation in this follow-up trial. 
In the event of an explant for exchange for another FDA approved VAD (e.g. HMII®), adverse 
events will be collected until the induction of anesthesia for exchange. 
11.1 INTERMACS®-defined adverse events 
These INTERMACS®-defined adverse events include: 
• Major infection 
• Major bleeding 
• Neurological dysfunction 
• Device malfunction 
And also 
• Cardiac arrhythmia 
• Renal dysfunction 
• Hemolysis 
• Respiratory failure 
• Hepatic dysfunction 
• Right heart failure 
• Hypertension 
• Arterial non-CNS thromboembolism 
• Myocardial infarction 
• Venous thromboembolism 
• Pericardial fluid collection 
• Wound dehiscence 
• Psychiatric episode 
• Other adverse events 
 
The above referenced events will be coded as the INTERMACS® defined adverse event term.  
 
Events that fall into the category of INTERMACS® “Other” will be reviewed, classified, and 
coded according the Medical Dictionary for Regulatory Activities (MedDRA). 
 
 

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11.2 Device Malfunctions 
Information on device malfunctions reported by Investigators or reported directly to HeartWare 
will be reviewed and reported to FDA as required by the Medical Device Reporting regulations 
(21 CFR 803). 
HeartWare will conduct analyses on devices and device components returned to HeartWare to 
confirm device malfunctions. 
11.3 Definition of Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs 
(including an abnormal laboratory finding) in subjects, users or other persons whether or not 
related to the medical device.  This includes events related to the procedures involved in this Post 
Approval Study.  For users or other persons this is restricted to events related to the medical 
device. 
11.4 Definition of Serious Adverse Event (SAE) 
Serious Adverse events are those that: 
• Result in death 
• Are life-threatening 
• Require  intervention to prevent permanent impairment/damage 
• Result in persistent or significant disability/ incapacity 
• Require hospitalization or unduly prolongation of existing hospitalization 
• Result in congenital anomaly 
11.5 Unanticipated Adverse Device Effects 
Any serious adverse effects on health or safety, or any life-threatening problem caused by the 
LVAD that was not previously identified in nature, severity or degree of incidence in the 
protocol or any other serious problem associated with the device that relates to the rights, safety 
or welfare of the subject. 
11.6 Anticipated Adverse Events 
Adverse events that may be anticipated during the implant of the HeartWare® VAS, or are 
associated with the continued use and support on the device include the following: 
• Air Embolism 
• Aortic Insufficiency 
• Bleeding, Perioperative or Late 
• Cardiac Arrhythmias 
• Death 
• Device  Malfunction 
• Device Thrombosis 
• Driveline Infection 
• Driveline Perforation 
• Driveline Wire Damage 
• Erosions and other Tissue Damage 
• GI Bleeding/AV malformations 
• Hemolysis  
• Hepatic Dysfunction 

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• Hypertension 
• Interference with/from Other Devices 
• Local Infection 
• Multi-organ Failure 
• Myocardial Infarction 
• Neurologic Dysfunction 
• Organ Damage During Driveline Tunneling 
• Pericardial Effusion/Tamponade 
• Peripheral Thromboembolism 
• Platelet Dysfunction 
• Pleural effusion 
• Psychiatric Episodes 
• Renal Dysfunction 
• Re-operation 
• Respiratory Dysfunction 
• Right Ventricular Failure 
• Sensitivity to Aspirin 
• Sepsis 
• Stroke 
• Worsening Heart Failure 
• Wound Dehiscence 
 
11.7 Adverse Event Reporting Requirements 
Adverse events will be reported using the NIH funded INTEMACS registry definitions 
 
All adverse events will be recorded from the time of signature of Informed Consent until a 
subjects participation in the trial is considered complete, or at the time of induction of anesthesia 
if the device is explanted for recovery or transplantation or exchange to another FDA approved 
VAD (e.g. HMII®), or at the time the HeartWare® VAS is turned off in lieu of surgical explant.  
It is the responsibility of the investigators to inform their IRB of adverse events as required by 
their local IRB procedures. 
11.7.1 UADE Reporting 
HeartWare’s evaluation of the UADE must be reported to the FDA through Medical Device 
Reports (MDRs). UADE’s must be reported to all reviewing IRBs, and participating 
investigators within 10 working days of knowledge of the event by HeartWare.   
 
 

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12.0 
Device and Patient Management 
In the case of device replacement during the study for patient management please refer to the 
approved IFU for the HeartWare® VAS. 
12.1 Infection Control 
It is recommended that centers follow the Infection Control Guidelines in the IFU of the 
approved indication of the HeartWare® VAS. 
12.2 Anticoagulation Guidelines 
It is recommended that centers follow the Anticoagulation Guidelines in the IFU of the approved 
indication of the HeartWare® VAS. 
12.3 Return or Readmission to Hospital 
Patients must return and/or be readmitted to the hospital for any of the following conditions: 
• The occurrence of any HeartWare® VAS malfunctions or alarm conditions that cannot be 
immediately diagnosed and corrected in the field, the Guidelines are to be followed as 
listed in in the IFU of the approved indication. 
• Medical emergency (e.g., cardiac arrest, HeartWare® VAS stops, loss of consciousness). 
• Medical conditions (e.g., new onset infection, neurological complication) or other 
conditions as determined by the physician. 
• Loss of power to the residence that is expected to last a period of time equivalent to or in 
excess of one-half the available battery support time. 

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13.0 
Statistical Analysis 
Data collected in this study will be reported using summary tables and subject data listings. 
Descriptive statistics (n, mean, median, standard deviation, minimum and maximum) will be 
considered for continuous variables; frequencies and percentages will be considered for 
categorical variables. 
Baseline and demographic data will be summarized
 
 
For outcomes such as death, 
 a Kaplan-Meier (time to event) 
analysis will be used.  
 
For QOL, Neurocognitive and Functional assessments, analyses may involve a comparison to 
baseline.  
 
Adverse event analysis will include the percent of patients that experience events, the number of 
events, and the rate (represented as events per patient-year). 
14.0 
Detailed study timelines 
The following assumptions are made with regards to the timelines for metrics including study 
initiation, site and subjects enrollment:   
• The study will be initiated post approval of the HeartWare® VAS. 
• As a follow-on “Expected number of subjects enrolled per month” is dependent upon 
scheduled visits in prior IDE trials to allow enrollment into this PAS. 
• It is anticipated that “Expected duration of enrollment” will be within approximately 6 
months of PMA approval. 
Anticipated dates for key milestones and activities are listed below.   
• Expected date of  study initiation 
November 2012 
• Expected date of first IRB approval 
December 2012 
• Expected start of subject enrollment 
January 2013 
• Expected date of enrollment completion 
May 2013 
• Expected date of study follow-up completion  
November 2017 
• Expected date for Final Report submission 
February 2018 

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15.0 
Reporting Requirements (interim and final reports) 
Interim reports will be submitted at 6-months, 12 months, 18 and 24 months then yearly until the 
end of study follow-up.  The report after the last patient has completed the 5 year (60 month) 
follow-up visit post original device implant will be the end of study, or final report. 
16.0 
Regulatory and Ethical Considerations 
This trial is to be conducted according to the ethical principles that have their origin in the 
Declaration of Helsinki and that are consistent with ICH GCP and applicable regulatory 
requirement(s) including the Code of Federal Regulations 21CFR Part 812, 21CFR Part 54 and 
21CFR Part 56. 
Good Clinical Practice is a standard for the design, conduct, performance, monitoring, auditing, 
recording, analyses and reporting of clinical trials that provides assurance that the data and 
reported results are credible and accurate, and that the rights, integrity and confidentiality of the 
trial subjects are protected. 
The medical care given to, and medical decisions made on behalf of subjects should always be 
the responsibility of a qualified physician. Each individual involved in conducting the trial 
should be qualified by education, training and experience to perform his or her respective task(s). 
16.1 IRB Approval 
All centers are required to obtain IRB approval of the Post Approval Study, addenda, and 
Informed Consent Forms (ICFs) prior to the study start at that center.   This study will be 
undertaken only after full approval has been obtained from the applicable IRB and a copy of this 
approval has been received by HeartWare. 
16.2 Informed Consent 
The patient must give written informed consent to participate prior to enrollment in the trial.  No 
study procedures may be conducted unless consent is given and documented. 
Prior to participation in the trial, the subject, should receive a copy of the signed and dated 
written ICF and any other pertinent written information. 
All subjects will be informed that participation is voluntary and that they can cease participation 
at any time without necessarily giving a reason and without any penalty or loss of benefits to 
which they are entitled. 
The signed and dated consent form will be kept by the Investigator. 

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16.3 Patient Data Protection 
Patients will be identified on the CRF by a patient identification number.  The investigator will 
maintain a confidential patient identification list to link medical records and patient identification 
numbers. 
All data used in analysis and reports will be used without identifiable reference to the patient.  At 
all times throughout the study, confidentiality shall be observed by all parties involved. 
All patients consented for this study will be informed and must agree to the use and disclosure of 
their study information by the institution and investigators to HeartWare, their agents and 
representatives, the FDA or other government agencies or review boards.  This authorization is a 
HIPAA Authorization: Authorization to Use and Disclose Health Information.  If the institution 
requires that an IRB-specific Confidentiality Authorization (HIPAA) form be used, then the site 
must provide a copy of this form to HeartWare for review and approval. 
17.0 
Investigators, Investigator Responsibility and Trial Administrative 
Structure 
The Investigator is responsible for ensuring that the clinical study is performed in accordance 
with the Post Approval Study protocol, Declaration of Helsinki, ICH GCP Guidelines, and Code 
of Federal Regulations 21CFR Part 812, 21CFR Part 54 and 21CFR Part 56 and any country 
laws, as applicable. 
A Sub-Investigator (e.g., associates, residents, research fellows) is any individual member of the 
clinical trial team designated and supervised by the principal Investigator at a trial site to perform 
critical trial-related procedures and/or to make important trial-related decisions. 
The Investigator must maintain a signed list of appropriately qualified persons to whom they 
have delegated significant trial-related duties which must be specified. 
Trial-related medical decisions are the responsibility of a qualified physician (the Investigator or 
delegate). 
The standard requirements for IRB review, informed consent, Patient data protection, 
investigator agreements, financial disclosures, protocol deviations, device accountability, and 
investigator reports will apply. 
17.1 Investigator Agreement 
Prior to study initiation, the Investigator must sign an Investigator Agreement (HeartWare or to 
provide Investigator Agreement template to sites).  The Investigator Agreement identifies the 
Investigator’s legal and ethical commitments with respect to the conduct of the clinical study as 
defined in 21 CFR Part 812, Part 56, Part 50, and Part 54. 

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17.2 Financial Disclosure 
A Financial Disclosure Form must be reviewed and signed by the Investigator and sub-
investigator(s) prior to study initiation.  HeartWare or designee will provide Financial Disclosure 
Form to sites.  Updates to financial disclosure will be made during the course of the study and 
for 1 year following completion of the study (21 CFR Part 54).  The Financial Disclosure form is 
required to record the Investigator’s and Sub-Investigator’s financial interests in HeartWare, 
which may be a potential source of bias in the outcome of the clinical study. 
17.3 Post Approval Study Deviations and Medical Emergencies 
The Investigator will not deviate from the Post Approval Study protocol without the prior written 
approval of HeartWare except in medical emergencies or in unforeseen, isolated instances where 
minor changes are made that will not increase the subject’s risk or affect the validity of the study.  
In addition HeartWare will not allow any deviations/waiver from the Inclusion and Exclusion 
Criteria.  
In medical emergencies, prior written approval for deviations will not be required, but 
HeartWare personnel must be notified via telephone within 24 hours of occurrence. 
If there are any circumstances during the clinical trial which can affect the safety of the subjects, 
users or third person, HeartWare and the investigator will take all necessary security measures 
immediately to protect the subjects, users and third persons against direct or indirect risk.  
HeartWare and the investigator have to inform the responsible IRB/IEC immediately about these 
new circumstances and the measures taken. 
However in case of any deviation for a scheduled assessment e.g. out of window assessment, 
missing laboratory sample, and prior approval from HeartWare is required in advance for 
changes in or deviations from the Post Approval Study. 
17.4 HeartWare (Sponsor) 
HeartWare accepts the responsibilities of the Sponsor. 
17.5 Contract Research Organization 
A CRO (commercial, academic or other) may be employed by HeartWare to perform 1 or more 
of its trial-related duties and functions.  The extent of the delegation must be specified in a 
contract between the involved parties.  The CRO should implement quality assurance and quality 
control but HeartWare will have the right to supervise the implementation of the methods for 
quality assurance and quality control. 

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18.0 
Documentation of Trial Data 
18.1 Case Report Forms 
An Electronic Data Capture (EDC) system will be utilized to collect all patient data during the 
course of the study. Data must be entered into eCRFs in English.  The eCRFs are to be 
completed within 72 hours of the subject's visit, with the exception of results from tests 
performed outside the investigator's office, so that they always reflect the latest observations on 
the subjects participating in the study.  A predetermined/designated individual (s) will be 
responsible for completion of the Electronic Case Report Forms (eCRFs).  The PI will ultimately 
be responsible for the review, completion and accuracy of data entered into the eCRF.  
Completed eCRFs will be verified by a Sponsor monitor at the site at regular intervals 
throughout the study.  The Investigator will allow the monitor and the FDA or other regulatory 
bodies to review the study files, patient CRFs, medical records and other study-related 
documents. 
18.2 Data Management 
18.2.1 eCRF 
During data entry in the eCRF, queries will be directly issued to clarify missing data, 
inconsistencies and incorrect values.  After completion of the eCRF, further queries will be 
issued to the Investigator to clarify (e.g., inconsistencies resulting out of the medical and manual 
review).  Resolutions of queries will be made by the Investigator or the trial site’s designated 
persons. 
18.2.2 Coding 
Medication names will be coded using the World Health Organization Drug Dictionary.  Adverse 
events will be coded according to the NIH funded INTERMACS® registry definitions.  Adverse 
events categorized as “Other” within the INTERMACS® definitions will be coded using the 
Medical Dictionary for Regulatory Activities (MedDRA). 
18.2.3 Source data 
Source data is all information in original records and certified copies of original records of 
clinical findings, observations, or other activities in a clinical trial necessary for the 
reconstruction and evaluation of the trial.  Source data are contained in source documents which 
comprise clinical documentation, data and records (e.g., hospital records, clinical and office 
charts, laboratory notes, memoranda, evaluation checklists, pharmacy dispensing records, 
recorded data from automated instruments and data and records arising from other departments 
such as the pharmacy, laboratory and medico-technical departments). 
Clinical documentation relevant to the trial includes all records in any form including, but not 
limited to: 

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• Medical history/physical condition of the patient before enrollment sufficient to verify  
• Post Approval Study entry criteria 
• Dated and signed notes for specific results of procedures and exams 
• Laboratory reports 
• Information related to adverse events 
• Notes on subject’s condition with device implanted and when explanted 
• Stroke Scale and Quality of Life studies 
• 
Discharge Summaries/Procedure reports 
• 
Autopsy reports 
All clinical documentation and data arising from the trial are to be kept by the Investigator who 
has to provide direct access for trial-related monitoring, audits, IEC review, and regulatory 
inspection. 
At the end of the trial, the Investigator will receive a certified copy of all data captured for their 
subjects, in human readable form, on a read-only CD-ROM.  Data captured of all subjects will be 
sent to the sponsor in human readable form, on a read-only CD-ROM for archiving. 
18.2.4 Data Review and Data Quality Assurance 
All eCRFs will be reviewed for completeness and clarity.  Missing data will be investigated by 
the monitor and clarified by study personnel as necessary.  HeartWare may request additional 
documentation such as physician procedure notes or written summaries relating to adverse events 
or procedures.  HeartWare will be responsible for the quality control of the database and 
confirming the overall integrity of the data. 
 

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19.0 
Data Monitoring and Administrative Requirements 
19.1 Monitoring of the Study 
HeartWare or designees will perform on-site monitoring visits as frequently as necessary.  Visits 
are usually made at regular intervals.  At these visits the monitor will compare the data entered 
into the eCRFs with the hospital or clinic records (source documents).  At a minimum, source 
documentation must be available to substantiate proper ICF procedures, adherence to protocol 
procedures, adequate reporting and follow-up of AEs, administration of concomitant medication 
and device receipt/ return records.   
The sponsor expects that, during monitoring visits, the investigator (and as appropriate the study 
coordinator) will be available, the source documentation will be available, and a suitable 
environment will be provided for review of study-related documents. 
19.2 Quality System, Audit and inspection 
HeartWare is responsible for implementing and maintaining quality assurance and quality 
control systems with written Standard Operating Procedures.  HeartWare is responsible for 
ensuring that all parties involved with the trial agree to direct access to all trial-related sites, 
source data and documents, and reports for the purposes of monitoring and auditing by 
HeartWare, and inspection by FDA. 
19.3 Audit 
The Investigator will permit an appointed person by the Quality Assurance Unit of HeartWare to 
audit the facilities and documentation at agreed times.  Auditors are independent of the clinical 
trial and its performance. 
An audit is the systematic and independent examination of trial-related activities and documents 
to determine whether the evaluated trial-related activities were conducted, and the data recorded, 
analyzed and accurately reported according to the Post Approval Study protocol, HeartWare 
Standard Operating Procedures, GCP and applicable regulatory requirements.  
19.4 Inspection 
Inspection is the act by the FDA of conducting an official review of the documents, facilities, 
records and other resources that are deemed by the FDA to be related to the clinical trial and that 
may be located at the trial site, at HeartWare, at the CRO, or at other facilities deemed 
appropriate by the regulatory authorities.  The Investigator is obliged to cooperate with any 
inspection. 
In the event of an FDA audit, the Investigator must allow FDA access to the study records for 
inspection and copying.  The Investigator must inform HeartWare of any FDA audit and provide 
HeartWare with a copy of Form FDA 483 (List of Observations), if issued. 

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19.5 Maintenance of Study Documentation 
The Investigator must maintain the following documents throughout the study: 
• Post Approval Study Protocol 
• IRB Approvals and Correspondence 
• IRB Approved ICF 
• Correspondence with HeartWare 
• Electronic Signature Authorization Form  
• Device Accountability (if applicable) 
• Investigator Agreements 
• Curriculum Vitae 
• Financial Disclosure Forms 
• Telephone Logs 
• eCRFs 
• Monitoring Visit Log 
• Laboratory Accreditation and Normal Values 
• Site Delegation and Responsibility log 
• Source Documents supporting information on eCRFs 
• Any other study specific documents 
19.6 Protocol Modifications 
Changes to the protocol during the trial will be documented as amendments.  The amended 
protocol will be signed by the relevant personnel at HeartWare, and by the Investigator(s).  
Depending on the contents of the amendment and local legal requirements, the amendment will 
be submitted to the relevant IRB. 
If an amendment substantially alters the trial design, increases the potential risk to the patients or 
affects the treatment of the patient, then the Informed Consent form must be revised and 
submitted to the relevant IRB/IEC for review and approval.  When a patient is currently 
undergoing trial procedures and is affected by the amendment, then the patient must be asked to 
consent again using the new Informed Consent form.  Informed Consent form must be used to 
obtain consent from new subjects before enrollment. 
19.7 Compliance and Investigational Site Termination 
19.7.1 Compliance 
Compliance is the adherence to all trial-related requirements, to Good Clinical Practice (GCP) 
and to regulatory rules and regulations. 

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19.7.2 Investigational Site Termination 
An initiative for center closure or study termination can be taken at any time either by the sponsor 
or by the investigator, provided there is reasonable cause and sufficient notice is given in advance 
of the intended termination.  HeartWare reserves the right to terminate an investigational site from 
the study for any of the following reasons: 
• Repeated failure to complete case report forms 
• Failure to obtain ICF 
• Failure to report SAEs and UADEs 
• Repeated protocol violations 
• Failure of investigator to comply with training or Instructions for Use 
• 
Insufficient patient and caregiver/Companion training 
19.8 Record Retention 
HeartWare and all participating Investigators must establish and maintain records and reports.  
The Investigator must maintain the signed Informed Consent Forms, eCRFs, study 
documentation (listed above) and source documents for at least 4 years after study completion or 
termination.  In accordance with the Investigator Agreement, HeartWare should be contacted if 
the Principal Investigator plans to leave or otherwise absent themselves from the investigational 
site.   
19.9 Site Training 
Sites will be trained by HeartWare on the device usage and on implant technique as appropriate.  
Training on GCP, Clinical Protocol required procedures and data collection will be provided by 
HeartWare and its vendor(s). 
19.10 Confidentiality of trial results 
The results of this trial are confidential and are not to be transmitted to a third party in any form 
or fashion. All persons involved in the trial are bound by this confidentiality clause. 
19.11 Publication policy 
The results of the trial will be published as soon as the data for the primary endpoint is available, 
initially as a poster/presentation at a congress, and then as a full publication in an international 
heart failure or cardiothoracic surgical journal. Draft manuscripts of publications will be 
prepared in co-operation between HeartWare and the Coordinating Investigator/Investigator(s). 
Joint publications are only possible if all parties agree. All editorial decisions will be made 
jointly by HeartWare and the Coordinating Investigator/Investigator(s). 
HeartWare reserves the right to review any publication pertaining to the trial before it is 
submitted for publication. Neither party has the right to prohibit publication unless publication 
can be shown to affect possible patent rights or regulatory submission requirements. 
In case of discrepancies with other contracts, the provisions of the protocol shall prevail. 

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19.12 Final report 
A final report, integrating medical and statistical aspects, will be prepared.  This will be 
authorized by the relevant personnel of HeartWare, and the Coordinating Investigator on behalf 
of the Investigators.  The Investigator(s) will be provided with a copy of the summary of the final 
report.  HeartWare will provide the FDA and IRB/IEC with the complete clinical trial report 
within 1 year after the end of the trial or on request, where required. 
 

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21.0 
References 
1  
Veronique RL, Go AS, Lloyd-Jones DM et al for the American Heart Association Statistics 
Committee and Stroke Statistics Subcommittee Heart Disease and Stroke Statistics—2011 
Update: American Heart Association Statistics Committee and Stroke Statistics 
Subcommittee Circulation 2011;123;e114-e118; originally published online Dec 15, 2010; 
DOI: 10.1161/CIR.0b013e3182009701. 
2  
Remme WJ, McMurray JJV, Rauch B, Zannad F, Keukelaar K, Cohen-Solal A, Lopez-
Sendon J, Hobbs FDR, Grobbee DE, Boccanelli A, Cline C, Macarie C, Dietz R, and 
Ruzyllo W. Public awareness of heart failure in Europe: first results from SHAPE. 
European Heart Journal (2005) 26, 2413–242. 
3  
Levy D, Enchaiah S, Larson MG et al. Long-Term Trends in the Incidence of and Survival 
with Heart Failure.  N Engl J Med, Vol. 347, No. 18; October 31, 2002. 
4  
Stehlik J, Edwards L, Kucheryavaya  A et al. The Registry of the International Society for 
Heart and Lung Transplantation: Twenty-eighth Adult Heart Transplant Report—2011. J 
Heart Lung Transplant. 2011. 
5  
Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky W, Long 
JW, Ascheim DD, Tierney AR, Levitan RG, Watson JT, Meier P, Ronan NS, Shapiro 
PA,Lazar RM, Miller LW, Gupta L, Frazier OH, Desvigne-Nickens P, Oz MC, Poirier VL; 
Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart 
Failure (REMATCH) Study Group. Long-term use of a left ventricular assist device for 
end-stage heart failure. N Engl J Med. 2001 Nov 15;345(20):1435-43. PubMed PMID: 
11794191