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Completed

NCT Number: NCT03022461

HeartMate 3 CE Mark Study Long Term Follow-up

The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up.

The study will be a single arm, prospective, multi-center, non-blinded and non-randomized study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that completed the 2-year follow-up in the HeartMate 3 CE Mark study.

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Key information

Conditions

Advanced Refractory Left Ventricular Heart Failure Cardiomyopathies Cardiovascular Diseases Heart Diseases Heart Failure Ventricular Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Alfred Hospital, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient or legal representative has signed Informed Consent Form (ICF).
  • Patient was enrolled in the HeartMate 3 CE Mark Study and continues to be supported with the HeartMate 3 LVAS after the 2 year CE Mark study follow-up.

Exclusion criteria

  • Patient does not consent to the continued data collection.

Treatment and study plan

Long Term Follow-Up

Other

Primary outcomes

  1. Survival

    Time frame: At 5 years post HM3 CE Mark study implant

    Subject outcomes and survival over time

Secondary outcomes

  1. EuroQoL 5D-5L (EQ-5D-5L) VAS Score

    Time frame: At 5 years post HM3 CE Mark study implant

    Quality of Life over time as measured by EuroQoL 5D-5L (EQ-5D-5L) VAS Score. The Visual Analog Scale (VAS) records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life

  2. Six Minute Walk Test (6MWT)

    Time frame: At 5 years post HM3 CE Mark study implant

    Functional status over time as measured by the Six Minute Walk Test (6MWT). The 6MWT is done to establish the amount of meters a subject can walk in 6 minutes

  3. New York Heart Association (NYHA)

    Time frame: At 5 years post HM3 CE Mark study implant

    Functional status over time as measured by New York Heart Association (NYHA). Patients are graded from 4 to 1 in order or symptoms:

    I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

    II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

    IIIA Marked limitation of physical activity. No dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

    IIIB Marked limitation of physical activity. Recent dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

    IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

  4. Adverse Events

    Time frame: Between 2 and 5 years post HM3 CE Mark study implant

    Number of Participants with Adverse Events

  5. Device Malfunctions

    Time frame: Between 2 and 5 years post HM3 CE Mark study implant

    Number of Participants with device malfunctions

  6. Reoperations

    Time frame: Between 2 and 5 years post HM3 CE Mark study implant

    Number of reoperations

  7. Rehospitalizations

    Time frame: Between 2 and 5 years post HM3 CE Mark study implant

    Number of rehospitalizations

  8. Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3)

    Time frame: As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first

    Modified Rankin Score >3 is considered debilitating. As in 3 cases the MRS evaluation was not available, a sensitivity analysis for the worst and best case scenario was performed.

    The MRS scale is as following:

    0: No observed neurological symptoms; 1: No significant neurological disability despite symptoms; able to carry out all usual duties and activities; 2: Slight neurological disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3: Moderate neurological disability; requiring some help, but able to walk without assistance; 4: Moderate severe neurological disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5: Severe neurological disability; bedridden, incontinent and requiring constant nursing care and attention as a result of a neurological deficit; 6: Dead

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

HeartMate 3 CE Mark Study Long Term Follow-up Clinical Investigation Plan

Acronym: HM3 CE LTFU

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2017
Registry last updated
Jun 27, 2022

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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