NCT00121485

Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy

The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• 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 Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation. The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).

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. The Destination Therapy trial is a prospective, randomized, unblinded, non-inferiority evaluation of the HeartMate II LVAS, compared to the HeartMate XVE.

Conditions

• Heart Failure, Congestive
• Ventricular Dysfunction
• Cardiomyopathies

Interventions

Type	Name	Description
DEVICE	Left Ventricular Assist System (LVAS)	Implantation of left ventricular assist device for hemodynamic support

Timeline

• Start date: 2005-02-01
• Primary completion: 2009-06-01
• Completion: 2012-01-01
• First posted: 2005-07-21
• Last updated: 2022-06-27
• Results posted: 2013-10-29

Locations

47 sites across 2 countries: United States, Canada