Coronary Artery Disease (CAD) happens when the arteries that send blood to the heart muscle harden and narrow. CAD is the most common type of heart disease in the United States.
Programs + Services
Explore the Interventional Cardiology Center at Tufts Medical Center in Boston that offers non-surgical procedures for treating serious heart disorders.
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Discover The Women’s Heart Clinic at Tufts Medical Center and learn more about the cardiologists dedicated to providing women with the best heart care.
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Research + Clinical Trials
Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 60 sites in the US. Control device will be the Abiomed Impella® Recover® LP 2.5 Percutaneous Cardiac Support System.
Additionally, the study will include a nonrandomized roll-in phase at each site. Each site must first enroll and treat up to 3 patients in the nonrandomized roll-in phase before entering the randomized phase.
Assess the safety and efficacy of the HeartMate PHP in supporting patients with severe symptomatic coronary artery disease with diminished but stable cardiovascular function, who are undergoing elective or urgent high risk percutaneous coronary interventions (PCI) but are not candidates for coronary artery bypass graft (CABG) surgery.
Proposed Indications The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent,
hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction. Nonrandomized Roll-In Phase: Up to 180 patients undergoing PCI per the Inclusion/Exclusion criteria; up to 3 roll-in patients per site.
Randomized Phase: Up to 425 patients undergoing PCI per the Inclusion/Exclusion criteria.
Data will be collected at baseline, during the PCI procedure, postprocedure, discharge, and 90 days post device removal.
All patients will have a follow-up visit at 90 days post-device removal.
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