Clinical Trial: Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial

Brief Summary: The primary objective of this study is to assess reasonable safety and performance of the HeartMate PHP to provide hemodynamic support for up to 72 hours in patients with cardiogenic shock requiring stabilization.

Detailed Summary: The HeartMate PHP is a catheter-based axial flow pump designed to provide partial left ventricular circulatory support. This prospective, nonrandomized, controlled, single-arm, multi-center, open-label trial will evaluate the safety and performance of the device in patients with cardiogenic shock.
Sponsor: Thoratec Corporation

Current Primary Outcome: Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2 [ Time Frame: 72 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome: An assessment of major adverse events [ Time Frame: 72 hours ]

Original Secondary Outcome: Same as current

Information By: St. Jude Medical

Dates:
Date Received: October 29, 2014
Date Started: October 2014
Date Completion:
Last Updated: April 13, 2017
Last Verified: April 2017