Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Adv… (NCT06526195) | Clinical Trial Compass
RecruitingNot Applicable
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
United States850 participantsStarted 2024-12-13
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure
✓. LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m²
✓. 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)
✓. NYHA Class IIIB or NYHA Class IV
✓. Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months
✓. Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant
✓. Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group
✓. Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days.
Exclusion criteria
✕. Subject is \< 18 years of age at the time of informed consent.
✕. Dependent on IV inotrope in the last 30 days.
✕. Contra-indications to HM3 LVAS or CardioMEMS HF system.
✕. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy.
What they're measuring
1
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