Evaluating the HeartMate 3™ in a Post-Market Approval Setting: The HeartMate 3 Registry (ELEVATE™)
Conditions: Heart Failure, Cardiovascular Disease, Ventricular Dysfunction
Sponsor: Abbott Medical Devices

SJM-CIP-10188-C 
ELEVATE Registry Protocol Version 3.0, 20 June 2019 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used 
without the express written consent of Abbott 
Page 1 of 22 
 
 
 
 
 
 
 
 
 
 
 
 
 
HeartMate 3 Registry: 
Evaluating the HeartMate 3TM with Full MagLev 
Technology in a Post-Market Approval Setting 
(ELEVATETM) 
 
 
 
Sponsor:   
St. Jude Medical BVBA (formerly Thoratec) 
Da Vincilaan 11 F 
1935 Zaventem  
Belgium 
  
Phone:  +32 027746811 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ELEVATE Registry Protocol Version 3.0, 20 June 2019 
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without the express written consent of Abbott 
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REVISION HISTORY 
 
Version 
Date 
Revision Summary 
NA 
09-Jan-2015 Original Protocol for Kazakhstan. 
1 
08-Mar-2015 Original Protocol for Europe. 
1.1 
16-Dec-2015 
Addition of retrospective enrollments  
(implemented only in centers where subjects were not enrolled 
consecutively). 
2.0 
05-Dec-2016 
Addition of anonymized data collection for subjects with outcome prior 
consenting 
(implemented only in centers where subjects implanted with HM3 
expired prior having the chance of signing the Informed Consent 
Form). 
3.0 
20-Jun-2019 
Subject follow up extended to 5 years. 
Introduction of a minimum compliance threshold and early study 
termination.  
SAE reporting timelines requirement added. 
Revised sponsor from Thoratec to St Jude Medical/Abbott. 
Revised patient to subject throughout the document 
 
 
 
 
 
 
COMPLIANCE STATEMENT 
 
This clinical investigation will be conducted in accordance with this Clinical Investigation Plan, 
the Declaration of Helsinki, ISO14155:2011 standards and the appropriate local legislation(s). 
The most stringent requirements, guidelines or regulations must always be followed. The 
conduct of the clinical investigation will be approved by the appropriate Ethics Committee (EC) 
of the respective clinical site and as specified by local regulations. 
 
 
 

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ELEVATE Registry Protocol Version 3.0, 20 June 2019 
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without the express written consent of Abbott 
Page 3 of 22 
 
TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ..................................................................................................... 4 
TABLE OF APPENDICES ....................................................................................................... 6 
1 
Introduction ...................................................................................................................... 7 
2 
Registry Design ................................................................................................................ 7 
2.1 
Scope ...................................................................................................................... 7 
2.2 
Subject Eligibility ..................................................................................................... 7 
2.2.1 Special circumstances when consent cannot be obtained ............................ 7 
2.3 
Follow-up ................................................................................................................. 7 
2.4 
Design ..................................................................................................................... 8 
2.4.1 Data collection .............................................................................................. 8 
2.4.2 Long Term Follow-Up ................................................................................... 8 
2.4.3 Early Study Termination ............................................................................... 8 
2.4.4 Endpoints ..................................................................................................... 8 
3 
Data Collection ................................................................................................................. 8 
3.1 
Database ................................................................................................................. 9 
3.2 
Pre-implant Demographics and Profile .................................................................... 9 
3.3 
Implant .................................................................................................................... 9 
3.4 
Post-Implant Follow-up ............................................................................................ 9 
3.4.1 Adverse Events (AE) .................................................................................... 9 
3.4.2 Reoperations ................................................................................................ 9 
3.4.3 Rehospitalizations ...................................................................................... 10 
3.4.4 Outcomes ................................................................................................... 10 
4 
Data Analysis ................................................................................................................. 10 
5 
Subject Safety ................................................................................................................ 10 
5.1 
Risks ..................................................................................................................... 10 
5.2 
Mitigations ............................................................................................................. 10 
5.3 
Benefits ................................................................................................................. 10 
6 
Ethical Requirements ..................................................................................................... 11 
6.1 
Informed Consent for Data Collection .................................................................... 11 
6.2 
Ethics Committee Review ...................................................................................... 11 
6.3 
Data Handling and Record Keeping ...................................................................... 11 
6.9 
Monitoring ............................................................................................................. 13 
7 
HM3 Post-Market Registry Visit Schedule ...................................................................... 14 
 
 
 

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ELEVATE Registry Protocol Version 3.0, 20 June 2019 
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LIST OF ABBREVIATIONS 
6MWT .............. Six-Minute Walk Test 
AAA .................. Abdominal Aortic Aneurysm 
ACE ................. Angiotensin Converting Enzyme 
ADE ................. Adverse Device Effect 
AE .................... Adverse Event 
AI ..................... Aortic Insufficiency 
AICD ................ Automatic Internal Cardiac Defibrillator 
ALT .................. Alanine Aminotransferase 
ARB ................. Angiotensin Receptor Blocker 
AST .................. Aspartate Aminotransferase 
AV .................... Aortic Valve 
BNP ................. B-type Natriuretic Peptide 
BSA .................. Body Surface Area 
BUN ................. Blood Urea Nitrogen (Urea, blood) 
CE .................... Conformité Européenne  
CI ..................... Cardiac Index 
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 
CV .................... Cardiovascular 
CVP ................. Central Venous Pressure 
EC .................... Ethics Committee 
ECG ................. Electrocardiogram 
eCRF................ Electronic Case Report Form 
EDC ................. Electronic Data Capture 
EEG ................. Electroencephalogram 
eGFR ............... Glomerular Filtration Rate  
EQ-5D-5L ......... EuroQol Health Utility Index 
FEV1……………………Forced Expiratory Volume in one second 
FVC…………….Forced Vital Capacity 
GCP ................. Good Clinical Practices 
HF .................... Heart Failure  
HM3 ................. HeartMate 3 
HR .................... Heart Rate 
Hs-CRP ............ High Sensitivity C-reactive Protein 
IABP ................. Intra Aortic Balloon Pump 
ICD ................... Internal Cardiac Defibrillator 
ICF ................... Informed Consent Form 
INR ................... International Normalized Ratio 
INTERMACS….Interagency Registry for Mechanically Assisted Circulatory Support 
LDH .................. Lactic Acid Dehydrogenase 
LOS .................. Length of Stay 
LV .................... Left Ventricle 
LVAD................ Left Ventricular Assist Device 
LVAS ................ Left Ventricular Assist System 

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ELEVATE Registry Protocol Version 3.0, 20 June 2019 
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LIST OF ABBREVIATIONS 
LVEDD ............. Left Ventricular End Diastolic Diameter 
LVEF ................ Left Ventricular Ejection Fraction 
LVESD ............. Left Ventricular End Systolic Diameter 
MB ................... Myocardial Band 
MCS ................. Mechanical Circulatory Support 
MR ................... Mitral Regurgitation 
NT-ProBNP ...... N terminal B-type natriuretic peptide  
NYHA ............... New York Heart Association 
PHgb ................ Plasma Free Hemoglobin 
PRBC ............... Packed Red Blood Cells 
PT .................... Prothrombin Time 
PTT .................. Partial Thromboplastin Time 
PVD ................. Peripheral Vascular Disease 
PVR ................. Pulmonary Vascular Resistance 
RV .................... Right Ventricle 
RVAD ............... Right Ventricular Assist Device 
SAE .................. Serious Adverse Event 
SBP .................. Systolic Blood Pressure 
SHFM ............... Seattle Heart Failure Model 
Thoratec ........... Thoratec Corporation 
TR .................... Tricuspid Regurgitation 
VAD ................. Ventricular Assist Device 
WBC ................ White Blood Cells 
 

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ELEVATE Registry Protocol Version 3.0, 20 June 2019 
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Page 6 of 22 
TABLE OF APPENDICES 
Appendix 
Contents 
1 
Anticipated Adverse Event Definitions 
2 
INTERMACS Profile/Classification 
3 
NYHA Classification 
4 
6MWT ELEVATE 

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ELEVATE Registry Protocol Version 3.0, 20 June 2019 
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the express written consent of Abbott 
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1 
INTRODUCTION 
The purpose of this post-market registry is to collect data and evaluate the real-world experience of 
the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) in a post-approval setting. The data 
collection will be similar to the HM3 CE Mark study in order to be able to compare the pre-market 
to post-market results and to continue to have a more robust HM3 dataset.   
 
This post-market registry will be initiated after receipt of the CE Mark and commercial approval of 
the HM3 LVAS.   
 
This protocol is being amended to include long term follow-up of the ELEVATE Registry Study 
subjects. The subjects that are still implanted with the HM3 LVAD after completing the 2-year 
follow up will be re-consented and their follow-up will be extended for  an additional 3 years (a total 
of 5 years of follow-up post-implant). This will allow for the evaluation of late occurring  adverse 
events, long-term quality of life, functional status and will provide more information on the real 
world treatment with the HM3 LVAD of advanced heart failure subjects.   
 
The original sponsor of this study and manufacturer of the HM3 LVAS, Thoratec Corporation, was 
acquired by St. Jude Medical on October 8, 2015. St Jude Medical was further acquired by Abbott 
on January 4, 2017. St. Jude Medical is currently the study sponsor however, due to the recent 
acquisition, there may be reference to Abbott in this document. 
 
2 
REGISTRY DESIGN 
2.1 
Scope 
This registry will include all subjects that receive the HM3 LVAS in the post-market setting. 
This registry will include up to 500 subjects in up to 50 centers. Consecutive subject 
enrollment (at least 5 consecutive subjects) is recommended to minimize subject selection 
bias and provide a more robust dataset. A log should be maintained of any subjects that are 
not included in this Registry and reasons for non-inclusion.      
2.2 
Subject Eligibility 
Any subject that is determined to meet the HM3 commercially approved labelling indication 
and that is implanted or has been implanted with the HM3 and has consented to the registry 
data collection can be enrolled in this registry.   
2.2.1 Special circumstances when consent cannot be obtained 
To ensure that survival is accurately reported in this Registry, for subjects that have 
had an outcome prior to consenting no consent will be obtained and the following data 
will be collected: 
• 
Duration (days) of HM3 support; 
• 
Subject outcome (transplanted, explanted or expired). If the subject expired, the 
cause of death. 
For subjects that have had an outcome after the 24 months visit and prior to 
reconsenting for the long term follow up, the same data will be collected 
retrospectively.  
2.3 
Follow-up  
Subjects will be followed in the registry to 24 months post-implant or outcome (transplanted, 
explanted for recovery or expired), whichever occurs first.  

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ELEVATE Registry Protocol Version 3.0, 20 June 2019 
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Subjects who provide consent for the extended follow up period (CIP Version 3.0 and newer) 
will be followed in the registry through 60 months post implant or until they meet another 
study outcome (transplanted, explanted for recovery or expired), whichever occurs first. 
2.4 
Design 
This is a prospective observational registry, subjects can be enrolled retrospectively from the 
date HM3 received the CE Mark and prospectively until the sample size is reached.    
2.4.1 Data collection 
Data collection will include pre-implant, implant and post-implant at hospital 
discharge, 6 months, 12 months and 24 months.  
For those subjects who provide consent for the extended follow up period, additional 
follow ups are planned at 36, 48 and 60 months while the subject is being supported 
on the HM3 LVAS.   
2.4.2 Long Term Follow-Up  
The follow-up period is extended from 24 to 60 months post-implant. Subjects will be 
reconsented to allow data collection in the additional follow ups.  
If subject is consented after they have had their standard of care 36 or 48 month 
visits, data will be collected restrospectively and the subject will be scheduled 
prospectively for the next protocol required follow-up. 
The follow-up extension will allow the evaluation of late occurring adverse events, 
long-term quality of life, functional status and provide more information on the real-
world experience of the HM3 LVAS in a post-approval setting.  
2.4.3 Early Study Termination  
The Sponsor will monitor the study compliance through the follow-ups beyond 24 
months and every effort will be made to maintain a high level of compliance.  
If the overall study compliance (calculated as a proportion between subjects active in 
the study vs the total amount of subjects still on HM3 support) or the followup visit 
compliance (calculated as a proportion between expected and received follow up 
data) cannot be maintained to at least 85% the study will be terminated prematurely 
by the sponsor. Subjects who have experienced an outcome as transplant, explant or 
death are not included in this compliance calculation. 
2.4.4 Endpoints  
The major endpoints that will be analyzed (at 2 years and at 5 years only for subjects 
who consent to participate in the extended Follow up) include:   
o Outcomes 
o Quality of Life as measured by the EuroQoL-5D-5L 
o Functional status as measured by the Six Minute Walk Test (6MWT) and New 
York Heart Association (NYHA) Classification. 
o Frequency and incidence of pre-defined anticipated adverse event rates 
o Frequency and incidence of device malfunction rates 
o Frequency and incidence of reoperations   
o Frequency and incidence of rehospitalizations 
3 
DATA COLLECTION 
Subjects will be followed per the hospital standard of care. Assessments collected in this registry 
are considered standard of care at most institutions. Please refer to Section 7 for the Visit 
Schedule.  

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ELEVATE Registry Protocol Version 3.0, 20 June 2019 
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3.1 
Database 
The data will be collected via an electronic data capture system (EDC). This database is 
maintained and administered by Abbott. Users will have unique usernames and passwords, 
and the user list will be maintained by a Sponsor’s  administrator for all study personnel.   
3.2 
Pre-implant Demographics and Profile 
The standard demographics of age, gender, and subject-described ethnicity will be recorded. 
Heart failure etiology, duration, and standard prognostic factors will be collected along with 
hemodynamic, laboratory and echocardiographic parameters closest to the time of implant. 
Co-morbidities and previous cardiovascular medical history will be also included.  The 
subjects functional and clinical status will be assessed by NYHA classification, INTERMACS 
Subject Profile and the 6 minute walk test. The subject will also be asked to complete the 
quality of life assessment.   
3.3 
Implant 
The elements which characterize the HM3 device and describe the implant procedure will be 
recorded in the Registry database. Note that the implant form that is provided in the pump 
packaging should be completed following usual commercial device reporting procedures.     
3.4 
Post-Implant Follow-up  
Refer to Section 7.0 for the visit schedule. Any subject related events (adverse events, 
reoperations, rehospitalizations, outcomes) should be reported as they occur. The date of 
discharge will be collected. The six minute walk and quality of life assessment will be 
administered at aseline and every follow-up as of 6 months visit.   
3.4.1 Adverse Events (AE) 
Adverse Events should be reported in the Registry database as they occur. The 
INTERMACS adverse event definitions will be used and can be found in Appendix 1. 
 
Note that the usual commercial device reporting procedures should be followed for 
any non-adverse events device malfunctions and product complaints. A Sponsor 
representative must be informed of any product related complaints.  
 
In the Registry adverse events are defined as any unfavorable and unintended sign, 
or symptom or disease temporally associated with the device. The AEs will be 
categorized as related to the device (Adverse Device Effect) or not. 
 
In addition all adverse events will be further categorized as serious or not. Serious 
adverse events (SAEs) are defined as those causing death, fetal distress, fetal 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.   
 
All SAEs will be categorized as related to the device (Serious Adverse Device Effect) 
or not and must be reported to the Sponsor no later than 3 calendar days from the 
day the site personnel became aware of the event (or as per the investigative site’s 
local requirements, if the requirement is more stringent than those outlined). 
3.4.2 Reoperations 
Any cardiac or non-cardiac surgical or operative procedures (including pump 
exchanges/replacements) that occur during the follow-up period will be collected.   

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ELEVATE Registry Protocol Version 3.0, 20 June 2019 
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Page 10 of 22 
3.4.3 Rehospitalizations 
Rehospitalizations and the associated reasons will be captured during the follow-up 
period.   
3.4.4 Outcomes 
The subjects’s outcome during the follow-up period will be captured and should be 
reported as occurs. The outcomes include:  transplanted, explanted, expired, or 
withdrawn.     
The subject retains the right to withdraw from the registry data collection at any time.  
Should the subjects elect to withdraw from the registry data collection, the reason for 
withdrawal should be documented.  
4 
DATA ANALYSIS  
The endpoints were selected to evaluate the same parameters as those collected in the HM3 CE 
Mark 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. Survival data will be presented using the Kaplan-Meier product limit 
method.  
 
Statistical analysis will be performed using SAS version 9.1 or higher. 
5 
SUBJECT SAFETY  
5.1 
Risks  
This registry will be initiated upon HM3 LVAS commercial approval therefore there is no 
added procedural risk to subjects participating in this post-market registry. No 
risk or procedures beyond those required for routine standard of care will be imposed. The 
data collected for this registry are mostly from medical chart abstraction. The only exception 
is the collection of functional capacity data and QoL data. These data are standard of care 
for heart failure subjects receiving VADs and are not considered greater than minimal risk. 
 
There is always the risk of loss of confidentiality. However, safeguards, policies and 
procedures are in place to keep personal health information confidential. No published or 
unpublished report or visual or speaking presentation about the study will include any 
material that will identify a subject participating in this registry.   
5.2 
Mitigations  
As the device will be commercially approved at the initiation of this post-market registry, 
mitigations and treatment for any adverse events associated with VAD therapy would be per 
the current practice standards and standards of care as determined by the treating physician.   
5.3 
Benefits 
There is no direct benefit to the heart failure subjects who participate in this post-market 
registry. However, future heart failure subjects may benefit from the knowledge gained 
through this registry.   
 

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Page 11 of 22 
6 
ETHICAL REQUIREMENTS 
6.1 
Informed Consent for Data Collection 
Prior to data entery into the registry the subject or legal representative must sign an informed 
consent. The informed consent must inform the subject that the subject’s data will be entered 
into a database outside of the hospital. The informed consent must have prior approval from 
the Ethics Committee (EC). 
The site is responsible for keeping the original signed informed consent form on file.  
6.2 
Ethics Committee Review 
Before initiation of the registry, EC approval of the protocol and the informed consent form 
(ICF) must be obtained. Any modifications made to the ICF should be sent to the Sponsor for 
approval, prior to submitting to the EC. Copies of the EC submission and approval, including 
the approved informed consent form, should be forwarded to the Sponsor prior to the 
enrollment of subjects into the registry. Copies of all submissions to and correspondence 
from the Ethics Committee (approvals and disapprovals) must be  maintained on file at the 
site.  
6.3 
Data Handling and Record Keeping 
 
Sponsor and/or its affiliates will maintain documentation of the systems and procedures used 
in data collection for the duration of the clinical investigation.  
 
CRF data collection will be performed through a secure web portal and only authorized 
personnel will access the Electronic Data Capture (EDC) system using a unique username 
and password to enter, review or correct data. Passwords and electronic signatures will be 
strictly confidential.   
 
The data will be subjected to consistency and validation checks within the EDC system and 
supplemental review by the Sponsor.    
 
At the conclusion of the clinical investigation, completed CRF images with the date-and-time 
stamped electronic audit trail indicating the user, the data entered, and any reason for 
change (if applicable) will be provided to the investigational sites.  
 
For the duration of the clinical investigation, the Investigator will maintain complete and 
accurate documentation including, but not limited to, medical records, clinical investigation 
progress records, laboratory reports, CRFs, signed ICFs, device accountability records (if 
applicable), correspondence with the IRB/EC and clinical investigation monitor/Sponsor, 
adverse event reports, and information regarding subject discontinuation or completion of the 
clinical investigation. 
 
6.4 
Protection of Personally Identifiable Information 
The Sponsor respects and protects personally identifiable information collected or 
maintained for this clinical investigation.  
 
The Sponsor implements technical and physical access controls to ensure that Personal 
Information is accessible only to and processed only on a ‘need to know’ basis, including 
periodic review of access rights, and revocation of access when an individual’s employment 
is terminated or the individual transitions to a role that does not require access to Personal 
Information, and appropriate restrictions on physical access to premises, facilities, 
equipment, and records containing Personal Information. 

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Page 12 of 22 
 
The Sponsor requires the investigational sites to transfer into Sponsor’s data management 
systems only Information (key-coded) necessary to conduct the Clinical Investigation, such 
as the subject’s medical condition, treatment, dates of treatment, etc. The Sponsor discloses 
as part of the clinical investigation informed consent process that some Sponsor 
representatives still may see Personal Information at the participating sites for technical 
support of the participating physicians on the device implant or procedures, monitoring and 
quality control purposes. Confidentiality of Personal Information will be observed by all 
parties involved at all times throughout the clinical investigation. The privacy of each subject 
and confidentiality of his/her information will be preserved in reports and when publishing any 
data. 
 
The Sponsor data management systems and processes were designed, developed, and 
tested according to industry standards to appropriately safeguard Confidential Information 
(including any Personal Information) against unauthorized access and/or interference by third 
parties, intrusion, theft, destruction, loss or alteration. Clinical Investigation data are 
encrypted in transit and at rest.  
 
The Sponsor maintains a Privacy Incident procedure that complies in all respects with 
Applicable Law and industry best practices. 
 
6.5 
Data Management Plan 
A Data Management Plan (DMP) will describe procedures used for data review, data 
cleaning, and issuing and resolving data discrepancies. If appropriate, the DMP may be 
updated throughout the duration of the clinical investigation. All revisions will be tracked and 
document controlled. 
 
6.6 
Source Documentation  
Regulations and GCP require the Investigator to maintain information in the subject’s original 
medical records that corroborates data collected on the CRFs. In order to comply with these 
regulatory requirements/GCP, the following information should be included in the subject 
record at a minimum and if applicable to the clinical investigation: 
• 
Medical history/physical condition of the subject before involvement in the clinical 
investigation sufficient to verify CIP entry criteria 
• 
Dated and signed notes on the day of entry into the clinical investigation referencing the 
Sponsor, CIP number, subject ID number and a statement that informed consent was 
obtained 
• 
Dated and signed notes from each subject visit (for specific results of procedures and 
exams) 
• 
Adverse events reported and their resolution, including supporting documents, such as 
discharge summaries, catheterization laboratory reports, ECGs, and lab results including 
documentation of site awareness of SAEs and of investigator assessment of device 
relationship for SAEs. 
• 
Subject’s condition upon completion of or withdrawal from the clinical investigation 
• 
Any other data required to substantiate data entered into the CRF 
• 
Subject reported outcome measures may be completed using CRF worksheets. These 
serve as the source documentation. 
 
6.7 
Case Report Form Completion  

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Primary data collection based on source-documented hospital and/or clinic chart reviews will 
be performed clearly and accurately by site personnel trained on the CIP and CRF 
completion. The investigator will ensure accuracy, completeness, legibility and timeliness of 
the data reported to the Sponsor on the CRFs and in all required reports. 
 
Data on CRFs will be collected for all subjects that are enrolled into the clinical investigation.  
Only authorized site personnel will be permitted to enter the CRF data through the EDC 
system deployed by the Sponsor. An electronic audit trail will be used to track any 
subsequent changes of the entered data. 
 
6.8 
Record Retention 
The Sponsor and Investigator/Site will archive and retain all documents pertaining to the 
clinical investigation as per the applicable regulatory record retention requirements. The 
Investigator must obtain permission from Sponsor in writing before destroying or transferring 
control of any clinical investigation records. 
 
6.9 
Monitoring 
The Sponsor will perform remote monitoring to ensure data is submitted in a timely manner, 
that the data is sensical and queries are resolved.  Ongoing communication with the site will 
be performed through written correspondence and telephone conversations.   
 
 

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Page 14 of 22 
 
7 
HM3 POST-MARKET REGISTRY VISIT SCHEDULE 
 
NOTE: Subject must have HM3 implanted and signed informed consent prior to data entry in registry 
 
 
Consent 
Pre-
Implant Implant Discharge 
Month 6 
(+/- 1 month) 
Month 12 
(+/- 1 month) 
Month 24 
(+/- 1 month) 
Month 36  
(+/- 1 month) 
Month 48  
(+/- 1 month) 
Month 60  
(+/- 1 month) 
As occurs 
Consent  
X 
 
 
 
 
 
 
 
 
 
 
Long Term Follow-Up Consent  
X 
 
 
 
 
 
 
 
 
 
 
Demographics 
 
X 
 
 
 
 
 
 
 
 
 
Medical & CV History 
 
X 
 
 
 
 
 
 
 
 
 
Vital Signs 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
Hemodynamic Measurements 
 
X 
 
 
 
 
 
 
 
 
 
Laboratory Assessments 
 
X 
 
 
X 
X 
X 
X 
X 
X 
 
Echocardiogram 
 
X 
 
 
X 
X 
X 
X 
X 
X 
 
EQ-5D-5L 
 
X 
 
 
X 
X 
X 
X 
X 
X 
 
NYHA Classification 
 
X 
 
 
X 
X 
X 
X 
X 
X 
 
INTERMACS Profile 
 
X 
 
 
 
 
 
 
 
 
 
Six Minute Walk Test 
 
X 
 
 
X 
X 
X 
X 
X 
X 
 
Current Cardiovascular 
Medications 
 
X 
 
 
 
 
 
 
 
 
 
Implant Data/CPB Time/Blood 
Products/Concurrent 
Procedures 
 
 
X 
 
 
 
 
 
 
 
 
Current Subject Status 
 
 
 
 
X 
X 
X 
X 
X 
X 
 
Pump Parameters 
 
 
 
X 
X 
X 
X 
X 
X 
X 
 
Subject Outcome 
 
 
 
 
 
 
 
 
 
 
X 
Long Term Follow-Up Subject 
Outcome 
 
 
 
 
 
 
 
 
 
 
X 
Rehospitalizations 
 
 
 
 
 
 
 
 
 
 
X 
Adverse Events  
 
 
 
 
 
 
 
 
 
 
X 
Device Malfunctions  
 
 
 
 
 
 
 
 
 
 
X 
Reoperations/Operative 
Procedures (incl pump 
replacements/exchanges) 
 
 
 
 
 
 
 
 
 
 
X 

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Page 15 of 22 
APPENDIX 1: ANTICIPATED ADVERSE EVENT DEFINITIONS 
(INTERMACS DEFINITIONS) 
 
Major 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: 
1. If transfusion is selected, then apply the following rules:  
During first 7 days Post-implant 
1. Adults (≥ 50 kg): ≥ 4U packed red blood cells (PRBC) within any 24 hour period during 
first 7 days post-implant. 
After 7 days Post-implant 
2. 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. 
 
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 * 
Device malfunction denotes a failure of one or more of the components of the MCS system 
which either directly causes or could potentially induce a state of inadequate circulatory support 
(low cardiac output state) or death. A failure that was iatrogenic or recipient-induced will be 
classified as an Iatrogenic/Recipient-Induced Failure.  
 
Device failure should be classified according to which components fails as follows: 
1) Pump failure (blood contacting components of pump and any motor or other pump actuating 
mechanism that is housed with the blood contacting components).  In the special situation of 
pump thrombosis, thrombus is documented to be present within the device or its conduits 
that result in or could potentially induce circulatory failure. 
2) Non-pump failure (e.g., electric power supply unit, batteries, controller, interconnect cable) 

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Page 16 of 22 
*Note: Device Malfunctions will be collected via the Sponsor’s commercial product event 
complaint procedure and not in the Registry database. All product related events should 
be reported to a Sponsor’s representative.   
 
Hemolysis 
A plasma-free hemoglobin value that is greater than 40 mg/dl, in association with clinical signs 
associated with hemolysis (e.g., anemia, low hematocrit, hyperbilirubinemia) occurring after the 
first 72 hours post-implant.  Hemolysis related to documented non-device-related causes (e.g. 
transfusion or drug) is excluded from this definition. 
 
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 
New onset blood pressure elevation greater than or equal to 140 mm Hg systolic or 90 mm Hg 
diastolic (pulsatile pump) or 110 mm Hg mean pressure (rotary pump).    
 
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 

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Page 17 of 22 
not use wall motion changes because the apical sewing ring inherently creates new wall motion 
abnormalities.)  
 
Non-Perioperative Myocardial Infarction 
The presence at > 7 days post-implant of two of the following three criteria:   
 
a) Chest pain which is characteristic of myocardial ischemia,  
b) ECG with a pattern or changes consistent with a myocardial infarction, and  
c) Troponin or CK (measured by standard clinical pathology/laboratory medicine methods) 
greater than the normal range for the local hospital with positive MB fraction (≥ 3% total CK).  
This should be accompanied by a new regional LV or RV wall motion abnormality on a 
myocardial imaging study. 
 
Neurologic Dysfunction 
Any new, temporary or permanent, focal or global neurological deficit ascertained by a standard 
neurological examination (administered by a neurologist or other qualified physician and 
documented with appropriate diagnostic tests and consultation note).  The examining physician 
will distinguish between a transient ischemic attack (TIA), which is fully reversible within 24 
hours (and without evidence of infarction), and a stroke, which lasts longer than 24 hours (or 
less than 24 hours if there is evidence of infarction).  Each neurological event must be 
subcategorized as:  
 
1) Transient Ischemic Attack (acute event that resolves completely within 24 hours with no 
evidence of infarction)  
2) Ischemic or Hemorrhagic Cerebral Accident/CVA (event that persists beyond 24 hours or 
less than 24 hours associated with infarction on an imaging study.  
 
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, hospitalization, or referral to a mental health professional for treatment.  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 (in children, creatinine greater than 3 times upper limit of 
normal for age) 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. 
 
Respiratory Failure 
Impairment of respiratory function requiring reintubation, tracheostomy or (for Subjects older 
than age 5 years) 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. 

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Page 18 of 22 
 
Right Heart Failure 
Symptoms and signs of persistent right ventricular dysfunction [central venous pressure (CVP) 
> 18 mmHg with a cardiac index <2.3 L/min/m2 in the absence of elevated left atrial/pulmonary 
capillary wedge pressure (greater than 18 mmHg), tamponade, ventricular arrhythmias or 
pneumothorax] 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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Page 19 of 22 
APPENDIX 2: INTERMACS PROFILE/CLASSIFICATION 
 
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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Page 20 of 22 
APPENDIX 3: NYHA CLASSIFICATION 
 
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. 

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Page 21 of 22 
APPENDIX 4: 6MWT ELEVATE 
 
SIX-MINUTE HALLWAY WALK TEST INSTRUCTIONS  
 
Purpose 
The purpose of the 6-Minute Hallway Walk test (6MWT) is to walk as far as possible for 6-
minutes, without running or jogging, as a way of measuring functional status. 
 
Preparing for the test 
1. Establish a 30-meter walking course in an enclosed corridor, preferably free of distractions 
and close to a wall so that if needed, the Subject may rest against it during the test (note: a 
treadmill is not an acceptable alternate method for this study).   
2. Mark the course at 3-meter intervals using a method unnoticeable to the Subject.   
3. Place noticeable markers at either end of the 30-meter course to indicate the turnaround 
points.  
4. The distance covered during the preceding walk test will not be revealed to the Subject 
during the study.  
5. A warm up prior to the test should not be performed. 
 
Explaining the test procedure to the Subject 
1. Clearly explain to the Subject what is required of him/her using the following instructions 
verbatim: 
THE PURPOSE OF THIS TEST IS TO WALK AS FAR AS POSSIBLE FOR SIX-MINUTES.  
YOU WILL START FROM THIS POINT AND FOLLOW THE HALLWAY TO THE MARKER 
AT THE END, THEN TURN AROUND AND WALK BACK.  WHEN YOU ARRIVE BACK AT 
THE STARTING POINT, YOU WILL GO BACK AND FORTH AGAIN.  YOU WILL GO BACK 
AND FORTH AS MANY TIMES AS YOU CAN IN THE SIX-MINUTE PERIOD.  IF YOU 
NEED TO, YOU ARE PERMITTED TO SLOW DOWN, TO STOP, AND TO REST AS 
NECESSARY.  YOU MAY LEAN AGAINST THE WALL WHILE RESTING, BUT RESUME 
WALKING AS SOON AS YOU ARE ABLE.  HOWEVER, THE MOST IMPORTANT THING 
ABOUT THE TEST IS THAT YOU COVER AS MUCH GROUND AS YOU POSSIBLY CAN 
DURING THE SIX MINUTES.  I WILL KEEP TRACK OF THE NUMBER OF LAPS YOU 
COMPLETE AND I WILL LET YOU KNOW WHEN THE SIX MINUTES ARE UP.  WHEN I 
SAY STOP, PLEASE STAND RIGHT WHERE YOU ARE. 
DO YOU HAVE ANY QUESTIONS ABOUT THE TEST? 
PLEASE EXPLAIN TO ME WHAT YOU ARE GOING TO DO. 
 
2. The Subject will re-state the instructions.  If the Subject does not seem to understand, 
repeat the entire instructions. 
 
Conducting the test 
1. Position the Subject at the starting line.   
2. Repeat the sentence: 
THE MOST IMPORTANT THING ABOUT THE TEST IS THAT YOU COVER AS MUCH 
GROUND AS YOU POSSIBLY CAN DURING THE SIX MINUTES. 
ARE YOU READY? 
START NOW, OR WHENEVER YOU ARE READY. 

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Page 22 of 22 
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. 
 
1. When only 15 seconds remain, state: 
IN A MOMENT I AM GOING TO TELL YOU TO STOP.  WHEN I DO, STOP RIGHT 
WHERE YOU ARE AND I WILL COME TO YOU.   
 
9. When the timer reads 6-minutes, instruct the Subject to STOP and walk over to him/her. 
Consider bringing a chair if the Subject appears exhausted.  Mark the spot where the 
Subject stopped.   
  
If the Subject wishes to stop walking during the test 
If the Subject is slowing down and expresses that he/she wants to pause, keep the timer 
running and state: 
REMEMBER, IF YOU NEED TO, YOU MAY LEAN AGAINST THE WALL UNTIL YOU 
CAN CONTINUE WALKING AGAIN. 
 
If the Subject wishes to stop before the 6-minutes are complete and refuses to continue 
(or you decide that he/she should not continue), provide a chair for the Subject to sit on 
and discontinue the test.  Record the distance completed, the time the test was stopped 
and the reason for pre-maturely stopping.   
 
Immediately after the test 
1. Total the number of completed laps and add the additional distance covered in the 
final partial lap.  Record the distance walked to the nearest meter. 
2. Observe the Subject sitting in a chair for at least 10 minutes after the test is 
completed.