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Can a mechanical heart pump offer a lifeline for advanced heart failure?

NCT ID NCT04915924

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This study follows up to 300 people with advanced heart failure in South Korea who receive a HeartMate 3, a mechanical pump that helps the heart circulate blood. Researchers will track how long patients survive without a debilitating stroke or the need for a pump replacement, as well as their ability to walk and overall heart function. The goal is to see how well this device performs in real-world clinical practice as a long-term support option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HeartMate 3 left ventricular assist system (LVAS), a mechanical heart pump implanted to help the heart pump blood
What this could lead to
If successful, this could confirm the HeartMate 3 as a safe and effective long-term support option for people with advanced heart failure, potentially improving survival and quality of life.
What could go wrong
This is an observational post-market study, not a randomized trial, so results may be influenced by patient selection. Risks include bleeding, stroke, infection, and device malfunction, which the study tracks closely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

358 people

The number who actually took part.

Started

Oct 2020

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria General Inclusion Criteria: All patients approved for HM3 implantation in Korea as per HIRA guidelines will be eligible to be enrolled in the PMS. Only the patients who provide written informed consent will be included in the study. If a subject has had an outcome after the HM3 implantation but prior to providing informed consent, no consent will be obtained, and a limited anonymized data will be collected. Exclusion Criteria This post market surveillance does not have specific exclusion criteria

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Conditions

The condition(s) this trial relates to.

advanced heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced heart failure

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, South Korea

  • Chonnam National University Hospital (CNUH)

    Gwangju, Gwangju, 58128, South Korea

  • Chungnam National University Hospital

    Daejeon, South Korea

  • Gachon University Gil Hospital

    Incheon, South Korea

  • Gangnam Severance Hospital

    Seoul, South Korea

  • Gyeongsang National University Changwon Hospital

    Changwon, South Korea

  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong, South Korea

  • Hallym University Sacred Heart Hospital

    Hwaseong, South Korea

  • Incheon Sejong Hospital

    Incheon, Nam-gu, 726, South Korea

  • Keimyung University Dongsan Medical Center

    Daegu, South Korea

  • Korea University Anam Hospital

    Seoul, South Korea

  • Korea University Ansan Hospital

    Ansan, South Korea

  • Kyungpook National University Hospital

    Daegu, South Korea

  • Pusan National University Hospital

    Busan, South Korea

  • Pusan National University Yangsan Hospital

    Yangsan, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Sejong Hospital

    Bucheon-si, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, South Korea

  • Seoul National University Hospital

    Ihwa-dong, South Korea

  • Seoul St. Mary's Hospital

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • St. Mary's Hospital, The Catholic University of Eunpyeong

    Seoul, South Korea

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