NCT00121472

Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation

The HeartMate II LVAS Pivotal Study Protocol, Bridge to Cardiac Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying. The HeartMate II LVAS was approved by the US FDA on April 21, 2008, as a bridge to cardiac transplantation (reference PMA P060040). It was approved for commercial distribution in Canada on May 20, 2009 (reference Medical Device Licence #79765). Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome.

Detailed description

The HeartMate II is a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the left ventricular apex via a rigid inlet cannula and ejects into the aortic root via an outflow cannula joined to the aorta with an end to side anastomosis. Power and control of the pump are delivered through a percutaneous cable from the pump to the belt-worn System Driver. Patient outcomes will be compared to objective performance criteria based on historical data from other Thoratec implantable ventricular assist devices.

Conditions

• Heart Failure, Congestive
• Ventricular Dysfunction
• Cardiomyopathies

Interventions

Type	Name	Description
DEVICE	Thoratec HeartMate II Left Ventricular Assist System (LVAS)	Implantation of ventricular assist device to provide hemodynamic support

Timeline

• Start date: 2005-03-01
• Primary completion: 2006-11-01
• Completion: 2010-05-01
• First posted: 2005-07-21
• Last updated: 2022-06-27
• Results posted: 2013-03-19

Locations

36 sites across 2 countries: United States, Canada