Life sciences · Interventional Study
ClinicalTrials.gov · November 5, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06526195). This is a study registration, not published results. Lead sponsor: Abbott Medical Devices. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 850 participants (ESTIMATED). Conditions: Heart Failure, Heart Diseases, Cardiovascular Diseases, Pulmonary Hypertension. Interventions: DEVICE: CardioMEMS HF System; DEVICE: HeartMate 3 Left Ventricular Assist System; OTHER: Guideline Medical Directed Therapy. Primary outcome 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 inotropes , 2 years. Brief 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.