Overview

This trial is active, not recruiting.

Conditions end-stage heart failure, cardiomyopathies
Treatment ventrassisttm left ventricular assist device
Phase phase 3
Sponsor Ventracor
Collaborator International Center for Health Outcomes and Innovation Research
Start date June 2007
End date June 2012
Trial size 225 participants
Trial identifier NCT00490321, CLP 12082

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Module A: Survival without a disabling stroke.
time frame:
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.
time frame:

Secondary Outcomes

Measure
•Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria (The following are general criteria; detailed criteria are included in the study protocol): - Eligible for either the VentrAssist or an FDA-approved DT LVAD - LVEF <=25% - Stage D heart failure - Ineligible for cardiac transplantation - Treated with standard heart failure therapy Exclusion Criteria (The following are general criteria; detailed criteria are included in the study protocol): - Contraindication to LVAD implantation - Contraindication to anticoagulant or anti-platelet agents. - Pre-existing mechanical circulatory support other than intra-aortic balloon pump - Therapy with an investigational intervention at the time of screening - A condition, other than heart failure, which would limit survival to less than 2 years

Additional Information

Official title Evaluation of the VentrAssistTM Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Ventracor.