Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (SHIELD II)

Brief description of study

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.

Detailed Study Description

Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 100 sites in the US. Control device will be any Abiomed Impella device approved for use in high-risk PCI. Nonrandomized roll-in phase: Each site must first enroll and treat up to 6 patients (up to 3 PHP and 3 Impella per site) Randomized phase: Up to 425 patients undergoing PCI per the Inclusion/Exclusion criteria.

Clinical Study Identifier: NCT02468778

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