RecruitingHeart FailureHeart DiseasesCardiovascular Diseases
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Eligible age
18+ yrs
Accepts
All genders
Locations
31 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Abbott Medical Devices
You may qualify if…
- ✓ 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 reasons OR peak VO2 ≤ 14 mL/kg/min (or \<50% of predicted peak VO2 value)
- ✓ 4. NYHA Class IIIB or NYHA Class IV
- ✓ 5. Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months
- ✓ 6. Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant
- ✓ 7. Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group
- ✓ Randomization Criteria:
You may not qualify if…
- ✕ 1. Subject is \< 18 years of age at the time of informed consent.
- ✕ 2. Dependent on IV inotrope in the last 30 days.
- ✕ 3. Contra-indications to HM3 LVAS or CardioMEMS HF system.
- ✕ 4. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy.
- ✕ 5. Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter.
- ✕ 6. Existence of ongoing MCS.
- ✕ 7. Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant.
- ✕ 8. History of any solid organ transplant.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06526195 · last updated 2026-06-10