MedTrace Logo

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

NCT00121472 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2022-06-27

Study results available
· View outcomes & findings →

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.

Conditions

  • Heart Failure, Congestive
  • Ventricular Dysfunction
  • Cardiomyopathies

Interventions

DEVICE

Thoratec HeartMate II Left Ventricular Assist System (LVAS)

Implantation of ventricular assist device to provide hemodynamic support

Sponsors & Collaborators

  • Thoratec Corporation

    collaborator INDUSTRY

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Pooja Chatterjee · Thoratec Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2006-11-30
Completion
2010-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00121472 on ClinicalTrials.gov