HeartMate 3 ELEVATE™ Registry (ELEVATE™)

February 28, 2025 updated by: Abbott Medical Devices

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

540

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients that receive the HeartMate 3 LVAS in the post-approval setting

Description

Inclusion:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 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.
Up to 5 Years post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQoL-5D-5L (EQ-5D-5L) VAS
Time Frame: 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).
Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS
Six Minute Walk Test (6MWT)
Time Frame: 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.
At 5 years after implant
New York Heart Association (NYHA) Classification
Time Frame: 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
At 5 years after implant
Adverse Events
Time Frame: 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)
Up to 5 years post-implant
Device Malfunctions
Time Frame: Up to 5 years post-implant
Number of device malfunctions reported
Up to 5 years post-implant
Reoperations
Time Frame: Up to 5 years post-implant
Frequency and incidence of reoperations after initial implant surgery
Up to 5 years post-implant
Rehospitalizations
Time Frame: Up to 5 years post-implant
Frequency and incidence of rehospitalizations after initial discharge from implant surgery
Up to 5 years post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Collaborators

Thoratec Corporation
Thoratec Europe Ltd

Investigators

  • Principal Investigator: Finn Gustafsson, MD, PhD, Rigshospitalet, Denmark
  • Principal Investigator: Jens Garbade, MD, PhD, Gesundheit Nord Klinikverbund Bremen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2015

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

July 3, 2015

First Submitted That Met QC Criteria

July 10, 2015

First Posted (Estimated)

July 15, 2015

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HeartMate 3™ Registry

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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