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Completed

NCT Number: NCT02497950

HeartMate 3 ELEVATE™ Registry

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

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Key information

Conditions

Heart Failure Cardiovascular Disease Cardiovascular Diseases Heart Diseases Ventricular Dysfunction

Sex eligibility

All sexes

Study type

Observational

Primary location

AJH - Wien, Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

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

Treatment and study plan

HeartMate 3

Device

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

Other names: HM3

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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

  4. 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)

  5. Device Malfunctions

    Time frame: Up to 5 years post-implant

    Number of device malfunctions reported

  6. Reoperations

    Time frame: Up to 5 years post-implant

    Frequency and incidence of reoperations after initial implant surgery

  7. Rehospitalizations

    Time frame: Up to 5 years post-implant

    Frequency and incidence of rehospitalizations after initial discharge from implant surgery

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • Thoratec Corporation
  • Thoratec Europe Ltd

Registry information

Official study title

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

Acronym: ELEVATE™

Important dates

Study start
2015
Primary completion
2019
Study completion
2022
First posted
Jul 15, 2015
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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