Last updated on June 2019

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

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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 electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events

Detailed Study Description

Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 120 sites in the US and Europe. Control device will be any Abiomed Impella device approved for use in high-risk PCI.

This clinical investigation is divided into two phases, a feasibility phase and a pivotal phase.

• Feasibility Phase: Includes 75 roll-in and 120 randomized subjects registered under the CIP versions 1-4 at 48 sites in the United States (U.S.) prior to January 30, 2017
• Pivotal Phase: Includes subjects to be registered under the current or later version of the CIP at up to 120 sites in the U.S. and Europe

Non-randomized Roll-in Cohort: Up to 480 subjects with the HeartMate PHP; each operator must treat a minimum of 1 and up to 2 subjects with the HeartMate PHP first before becoming qualified to randomize subjects

Randomized Cohort: A minimum of 473 and a maximum of 716 subjects will be randomized in a 2:1 ratio to the HeartMate PHP and Impella.