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TEAM-HF Trial for Advanced Heart Failure

This study is looking at the safety and effectiveness of the HeartMate 3 Left Ventricular Assist System (LVAS) compared to standard medical care (Guideline Medical Directed Therapy) for people with advancing heart failure. The HeartMate 3 LVAS is a device that helps your heart pump blood. You might be able to join if you have advanced heart failure, your heart doesn't pump well (LVEF ≤30%), and you have difficulty with physical activity. The study aims to see if participants survive for two years without serious complications like disabling stroke, needing another device surgery, or worsening heart failure. The study is currently recruiting about 850 participants, but its exact status is unclear.

Study design
This interventional study plans to enroll about 850 participants. It compares the HeartMate 3 LVAS device to guideline-directed medical therapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years to assess survival and other health outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06526195

Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure

Recruiting
NAAges 18+InterventionalTreatment
Abbott Medical Devices
~850 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:CardioMEMS HF SystemHeartMate 3 Left Ventricular Assist SystemGuideline Medical Directed Therapy

At a glance

Recruiting sites
68 of 68 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Survival at 2 years free of disabling stroke, reoperation to replace the device, or worsening HF requiring listing for urgent heart transplantation or mechanical circulatory support, enrollment into hospice, or dependence on IV inotropes
Measured over 2 years

Conditions

Heart Failure
Heart Diseases
Cardiovascular Diseases
Pulmonary Hypertension

Explore related trials

Heart Failure

NCT06526195

Where you'd take part

This study runs at 68 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • A.O.U. Citta della Salute e della Scienza di Torino

    Turin, Piedmont, Italystudy coordinator listed

    Recruiting

  • Abington Memorial Hospital

    Abington, Pennsylvaniastudy coordinator listed

    Recruiting

  • Advocate Health & Hospitals Corporation

    Oakbrook Terrace, Illinoisstudy coordinator listed

    Recruiting

  • AKH -Wien

    Vienna, State of Vienna, Austriastudy coordinator listed

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Recruiting

  • Ascension Texas Cardiovascular

    Austin, Texasstudy coordinator listed

    Recruiting

  • Aurora Medical Group

    Milwaukee, Wisconsinstudy coordinator listed

    Recruiting

  • Banner-University Medical Center Phoenix

    Phoenix, Arizonastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kelly O'Connell, PhD · STUDY_DIRECTOR · Abbott

Who to contact

Nourdine Chakouri, PhD
[email protected]
925-989-5982
Email the study team

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What this trial measures

  • Survival at 2 years free of disabling stroke, reoperation to replace the device, or worsening HF requiring listing for urgent heart transplantation or mechanical circulatory support, enrollment into hospice, or dependence on IV inotropes2 years

    The powered primary endpoint will be analyzed at 2 years following the Com-Nougue method and will be compared between the HM3 Group (HM3 LVAD) and the Control Group (GDMT) within the Intention-to-treat (ITT) population.