HeartMate 3 ELEVATE™ Registry

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT02497950

Collaborator

Thoratec Europe Ltd (Industry), Thoratec Corporation (Industry)

540

Enrollment

Locations

76.6

Actual Duration (Months)

20.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Cardiovascular Disease Ventricular Dysfunction	Device: HeartMate 3

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

540 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Evaluating the HeartMate 3™ in a Post-Market Approval Setting: The HeartMate 3 Registry (ELEVATE™)

Actual Study Start Date :

Oct 13, 2015

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
HeartMate 3 This registry will include all patients that receive the HM3 LVAS in the post-market setting	Device: HeartMate 3 Any patient that is determined to meet the HM3 commercially approved labelling indication and that is implanted with the HM3 Other Names: HM3

Arm

Intervention/Treatment

HeartMate 3

This registry will include all patients that receive the HM3 LVAS in the post-market setting

Device: HeartMate 3

Any patient that is determined to meet the HM3 commercially approved labelling indication and that is implanted with the HM3

Other Names:

HM3

Outcome Measures

Primary Outcome Measures

Survival [Up to 24 Months post-implant]
Patients will be followed in the registry to 24 months post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.

Secondary Outcome Measures

EuroQoL-5D-5L (EQ-5D-5L) [Baseline, 6 months, 12 months and 24 months while the patient is being supported on the HM3 LVAS]
EQ-5D-5L measures self-rated health states/quality of life in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and extreme problems)
Six Minute Walk Test (6MWT) [Baseline, 6 months, 12 months and 24 months while the patient is being supported on the HM3 LVAS]
The Six Minute Walk Test (6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.
New York Heart Association (NYHA) Classification [Baseline, 6 months, 12 months and 24 months while the patient is being supported on the HM3 LVAS]
NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort
Adverse Events [Up to 24 months]
Frequency and incidence of pre-defined anticipated adverse event rates
Device Malfunctions [Up to 24 months]
Frequency and incidence of device malfunction rates
Reoperations [Up to 24 months]
Frequency and incidence of reoperations after initial implant surgery
Rehospitalizations [Up to 24 months]
Frequency and incidence of rehospitalizations after initial discharge from implant surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion:

Patient consented to registry data collection
Patient has met the HeartMate 3 commercially approved labeling indication and is implanted with the HM3.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	AJH - Wien	Vienna	Austria	1090
2	Institute for Clinical and Experimental Medicine (IKEM)	Prague	Czechia	4
3	Rigshospitalet Copenhagen	Copenhagen	Denmark	2100
4	Universitatsklinikum Aachen	Aachen	Germany	52074
5	Herz- und Gefäßklinik Bad Neustadt a d Saale	Bad Neustadt an der Saale	Germany	97616
6	Herz-und Diabetes Zentrum NRW	Bad Oeynhausen	Germany	32545
7	Deutsches Herzzentrum Berlin	Berlin	Germany	13353
8	Medizinische Einrichtungen der Universitat Dusseldorf	Dusseldorf	Germany	40225
9	Universitäts-Herzzentrum Freiburg	Freiberg	Germany	79106
10	Medizinische Hochschule Hannover	Hannover	Germany	30625
11	Universitätsklinikum Jena	Jena	Germany	07740
12	Herzentrum Leipzig GmbH	Leipzig	Germany	04280
13	Universitätsklinikum Schleswig Holstein	Lubeck	Germany	23538
14	Otto-von-Guericke-Universitat Magdeburg	Magdeburg	Germany	39120
15	Universitätsklinikum Tübingen	Tubingen	Germany	72076
16	Sheba Medical Center	Tel Aviv	Israel	52621
17	Ospedale San Raffaele	Milano	Italy	20132
18	Az. Osp. San Camillo Forlanini	Roma	Italy	00152
19	Ospedale Civile Maggiore di Verona Borgo Trento	Verona	Italy	37126
20	National Research Center for Cardiac Surgery	Astana	Kazakhstan	010000
21	Erasmus MC - Thoraxcenter	Rotterdam	Netherlands	3015
22	UMC Utrecht	Utrecht	Netherlands	3584
23	Warsaw Institute of Cardiology	Warsaw	Poland	02-943
24	National Heart Centre Singapore	Singapore	Singapore	169609
25	Queen Elizabeth Hospital	Birmingham	United Kingdom	B15 2TH
26	Wythenshawe Hospital	Manchester	United Kingdom	M23 9LT