NCT00490321

VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy

Evaluation of the VentrAssistTM Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Ventracor · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of LVADs in providing long-term circulatory support for patients who have chronic stage D heart failure and are ineligible for a heart transplant. This is a multi-center, prospective, randomized, controlled clinical trial, which is comprised of two independent modules.

Detailed description

Currently, patients with Stage D heart failure who are not transplant candidates are treated with a spectrum of therapies, including specialized medical management as well as mechanical support with an LVAD approved by FDA for destination therapy. However, there is substantial variation in the therapeutic approaches employed to treat these patients, with relatively low numbers of patients receiving DT LVAD therapy to date. Therefore, the VentrAssist DT trial is designed to provide maximal flexibility to the investigators/clinicians to incorporate their clinical judgment in managing these complex patients.

Conditions

• End-stage Heart Failure
• Cardiomyopathies

Interventions

Type	Name	Description
DEVICE	VentrAssistTM Left Ventricular Assist Device

Timeline

• Start date: 2007-06-01
• Completion: 2012-06-01
• First posted: 2007-06-22
• Last updated: 2009-09-09

Locations

27 sites across 1 country: United States