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

Cardiomyopathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00490321
• Other study ID #: CLP 12082
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 20, 2007
• Last updated: September 4, 2009
• Start date: June 2007
• Est. completion date: June 2012

Study information

• Verified date: September 2009
• Source: Ventracor
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• Est. completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• End-stage Heart Failure
• Heart Failure

Intervention

Device:
• VentrAssistTM Left Ventricular Assist Device

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Montefiore Medical Center	Bronx	New York
United States	Northwestern University	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	Duke Medical Center	Durham	North Carolina
United States	Fairfax (Inova) Hospital	Falls Church	Virginia
United States	University of Florida	Gainesville	Florida
United States	Methodist Hospital	Houston	Texas
United States	St. Vincent's	Indianapolis	Indiana
United States	University of Wisconsin Hospital	Madison	Wisconsin
United States	Jackson Memorial	Miami	Florida
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Columbia University	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Rochester Medical Center University	Rochester	New York
United States	University of Utah	Salt Lake City	Utah
United States	University of Washington	Seattle	Washington
United States	Sacred Heart Medical Center	Spokane	Washington
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Ventracor	International Center for Health Outcomes and Innovation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Module A: Survival without a disabling stroke.
Primary	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	•Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment