NCT02279979

Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 85 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Cardiogenic Shock

Interventions

Type	Name	Description
DEVICE	HeartMate PHP	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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2014-10-31
• Last updated: 2023-07-21

Locations

6 sites across 4 countries: Czechia, Germany, Hungary, Netherlands