HeartMate 3 for Advanced Heart Failure

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

Recruiting N/A Interventional Study
Heart Failure Heart Diseases Cardiovascular Diseases Pulmonary Hypertension
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
850 (estimated)
Sponsor
Abbott Medical Devices · Industry
Who this trial is looking for

This trial is looking for patients with advanced heart failure who are not dependent on intravenous medications. Participants will be evaluated to see if a device called HeartMate 3 can help their heart function better compared to standard medical treatments.

Are You a Good Fit for This Trial?
Must be taking Heart Failure Medications
Rules you out Severe Lung DiseaseCirrhosisComplex Congenital Heart Disease

You may be able to join if

  • I have given my consent to participate in this trial.
  • I have a left ventricular ejection fraction (LVEF) of 30% or less.
  • I have had at least one heart failure-related hospital visit in the last year.
  • I have a limited ability to walk due to heart failure.
  • I can have a CardioMEMS PA Sensor implanted.
  • I am willing to receive the HeartMate 3 device if selected.
  • I have been stable on heart failure medications for at least 30 of the last 90 days.

You may not be able to join if

  • I am under 18 years old.
  • I have needed intravenous medications in the last 30 days.
  • I have certain medical conditions that prevent me from using HeartMate 3.
  • I have an active, uncontrolled infection.
  • I am currently pregnant or can become pregnant and won't use birth control.
  • I have a history of serious blood clots in the last 30 days.
  • I have any condition that could limit my survival to less than 24 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure 2. LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m² 3. Limited functional status as demonstrated by 6MWT ≤ 350 m due to HF related re…
Contacts

Nourdine Chakouri, PhD

925-989-5982

nourdine.chakouri@abbott.com

CONTACT