HeartMate 3 ELEVATE™ Registry

Completed

• Conditions: Cardiovascular Disease; Ventricular Dysfunction; Heart Failure

• Registration Number: NCT02497950
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-07-03
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-15
• Study Start: 2015-10-13
• Primary Completion: 2019-02
• Study Completion: 2022-02-28
• Results First Submitted: 2023-02-13
• Status Verified: 2024-04
• Results First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Results First Posted: 2025-03-20
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	Up to 5 Years post-implant	Patients will be followed in the registry to 5 years post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
EuroQoL-5D-5L (EQ-5D-5L) VAS	Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS	EuroQoL-5D-5L Visual Analog Score (VAS) measures self-rated health status/quality of life, with the patient indicating his/ger current status of health on a scale from 1 (extremely poor) to 100 (exceptionally good).
Six Minute Walk Test (6MWT)	At 5 years after implant	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	At 5 years after implant	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 5 years post-implant	Frequency and incidence of pre-defined anticipated adverse event rates for patients with available data (primary implant and pump exchanges)
Device Malfunctions	Up to 5 years post-implant	Number of device malfunctions reported
Reoperations	Up to 5 years post-implant	Frequency and incidence of reoperations after initial implant surgery
Rehospitalizations	Up to 5 years post-implant	Frequency and incidence of rehospitalizations after initial discharge from implant surgery

Trial Locations

Locations (26)

AJH - Wien; 🇦🇹 Vienna, Austria

Institute for Clinical and Experimental Medicine (IKEM); 🇨🇿 Prague, Czechia

Rigshospitalet Copenhagen; 🇩🇰 Copenhagen, Denmark

Universitatsklinikum Aachen; 🇩🇪 Aachen, Germany

Herz- und Gefäßklinik Bad Neustadt a d Saale; 🇩🇪 Bad Neustadt an der Saale, Germany

Herz-und Diabetes Zentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Medizinische Einrichtungen der Universitat Dusseldorf; 🇩🇪 Dusseldorf, Germany

Universitäts-Herzzentrum Freiburg; 🇩🇪 Freiberg, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

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