HeartMate 3 ELEVATE™ Registry (ELEVATE™)

June 23, 2022 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
        • Universitats-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
        • Universitätsklinikum Tübingen
  • 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

Genders Eligible for Study

All

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 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.
Up to 24 Months post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQoL-5D-5L (EQ-5D-5L)
Time Frame: 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)
Baseline, 6 months, 12 months and 24 months while the patient is being supported on the HM3 LVAS
Six Minute Walk Test (6MWT)
Time Frame: 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.
Baseline, 6 months, 12 months and 24 months while the patient is being supported on the HM3 LVAS
New York Heart Association (NYHA) Classification
Time Frame: 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
Baseline, 6 months, 12 months and 24 months while the patient is being supported on the HM3 LVAS
Adverse Events
Time Frame: Up to 24 months
Frequency and incidence of pre-defined anticipated adverse event rates
Up to 24 months
Device Malfunctions
Time Frame: Up to 24 months
Frequency and incidence of device malfunction rates
Up to 24 months
Reoperations
Time Frame: Up to 24 months
Frequency and incidence of reoperations after initial implant surgery
Up to 24 months
Rehospitalizations
Time Frame: Up to 24 months
Frequency and incidence of rehospitalizations after initial discharge from implant surgery
Up to 24 months

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

  • Study Director: Carlo Gazzola, Abbott

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 (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

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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