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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
        • Universitatsklinikum 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Thoratec Corporation
Thoratec Europe Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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