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Sponsors and Collaborators: |
Ventracor International Center for Health Outcomes and Innovation Research |
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Information provided by: | Ventracor |
ClinicalTrials.gov Identifier: | NCT00490321 |
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.
Condition | Intervention | Phase |
---|---|---|
End-Stage Heart Failure Cardiomyopathies |
Device: VentrAssistTM Left Ventricular Assist Device |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of the VentrAssistTM Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy |
Estimated Enrollment: | 225 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | June 2012 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (The following are general criteria; detailed criteria are included in the study protocol):
Exclusion Criteria (The following are general criteria; detailed criteria are included in the study protocol):
Contact: Helene Zintak | 973-426-5995 | helene.zintak@ventracor.com |
Contact: Frances McNamara | 973-426-5988 | frances.mcnamara@ventracor.com |
Study ID Numbers: | CLP 12082 |
Study First Received: | June 20, 2007 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00490321 History of Changes |
Health Authority: | United States: Food and Drug Administration |
VentrAssistTM LVAD End-stage heart failure Cardiomyopathy |
Heart Failure Heart Diseases Cardiomyopathies |
Heart Failure Heart Diseases Cardiovascular Diseases Cardiomyopathies |