3 results
Primary end points:Safety (>1 toxic death per arm) and tolerability (relevant grade 4 toxicities) in not more than 33% of patients for the three treatment arms.Secondary end points:* Reduction of grade 2-4 key side effects in the experimental…
To assess real world experience with HeartMate PHP post CE Mark approval in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing complex percutaneous coronary interventions (PCI).
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.