NCT00819793

CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass

Thoratec CentriMag VAS Failure-to-Wean From Cardiopulmonary Bypass Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	CentriMag Ventricular Assist System	All eligible subjects will receive the CentriMag Ventricular Assist System. The system is comprised of a single-use centrifugal blood pump, a motor, a primary drive console, a back up drive console and cannulae. Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.

Timeline

• Start date: 2008-10-01
• Primary completion: 2013-05-01
• Completion: 2013-09-01
• First posted: 2009-01-09
• Last updated: 2022-06-27
• Results posted: 2019-02-19

Locations

14 sites across 1 country: United States