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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
The HeartMate PHP system is a catheter-based heart pump and console designed to provide hemodynamic left ventricular support for up to 3 days to stabilize patients by maintaining adequate systemic cardiac output.
Na Homolce Hospital
Prague, Czechia
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia
Universitätskliniken Düsseldorf
Düsseldorf, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2
Time frame: 72 hours
An assessment of major adverse events
Time frame: 72 hours
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Semmelweis University Heart and Vascular Center
Budapest, Hungary
Erasmus Medical Center
Rotterdam, Netherlands