Evaluating Safety and Effectiveness of the HeartMate 3 Device Compared to Medical Therapy in Adults with Advanced Heart Failure

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the HeartMate 3 left ventricular assist system LVAS compared to guideline-directed medical therapy GDMT in adults with advanced heart failure HF who are ambulatory and not dependent on intravenous inotropes. The study focuses on patients with elevated mean pulmonary artery pressure PAP due to left ventricular failure, a group at higher risk of worsening HF despite optimal medical treatment. The trial seeks to identify whether earlier intervention with LVAS benefits these patients. Participants will be divided into groups based on their mean PAP levels measured by the CardioMEMS PA Sensor device, which monitors pulmonary artery pressure remotely. Those with elevated mean PAP 30 mmHg are randomized either to receive the HeartMate 3 LVAS within 14 days or to continue with GDMT per heart failure guidelines. Patients with lower mean PAP <30 mmHg join a single-arm registry to observe their disease progression while on medical therapy. All participants either have or will receive the CardioMEMS PA Sensor implant as part of the study. During the trial, participants will undergo regular assessments including survival without major complications such as disabling stroke or worsening heart failure requiring urgent interventions over two years. Quality of life, exercise capacity via six-minute walk tests, hospitalization rates, and adverse events will also be closely monitored. The study involves approximately 850 subjects across about 75 sites worldwide and aims to provide data on how best to manage advanced HF patients using mechanical circulatory support versus medical therapy alone.

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