NCT02156609

HeartMate PHP™ CE Mark Clinical Investigation Plan

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI), such as coronary stent placement.

Detailed description

The HeartMate PHP (percutaneous heart pump) is a catheter-based axial flow pump designed to provide partial left ventricular circulatory support. The primary objective of this prospective, nonrandomized, multi-center, open-label trial is to assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI).

Conditions

• High Risk Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DEVICE	Percutaneous ventricular support with the HeartMate PHP	The HeartMate PHP device will be inserted percutaneously prior to the start of high risk coronary interventions (complex disease, reduced ejection fraction, etc.) to provide hemodynamic support,

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2014-06-05
• Last updated: 2022-06-24

Locations

7 sites across 4 countries: Colombia, Netherlands, Paraguay, Poland