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

Phase 3

• Conditions: End-stage Heart Failure; Cardiomyopathies

• Registration Number: NCT00490321
• Lead Sponsor: Ventracor

Brief 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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-20
• Study First Submitted QC: 2007-06-20
• Study First Posted: 2007-06-22
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-04
• Last Update Posted: 2009-09-09
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Module A: Survival without a disabling stroke.
Module B: A composite endpoint of disabling stroke-free survival without device replacement or repair due to failure of the device to provide adequate circulatory support.

Secondary Outcome Measures

Name	Time	Method
•Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment

Trial Locations

Locations (26)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Jackson Memorial; 🇺🇸 Miami, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

St. Vincent's; 🇺🇸 Indianapolis, Indiana, United States

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

Newark Beth Israel Medical Center; 🇺🇸 Newark, New Jersey, United States

Scroll for more (16 remaining)