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

This study is currently recruiting participants.

Verified by Ventracor, December 2008

First Received: June 20, 2007 Last Updated: April 30, 2009 History of Changes

Sponsors and Collaborators:	Ventracor International Center for Health Outcomes and Innovation Research
Information provided by:	Ventracor
ClinicalTrials.gov Identifier:	NCT00490321

Purpose

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

MedlinePlus related topics: Cardiomyopathy Heart Failure

U.S. FDA Resources

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

Further study details as provided by Ventracor:

Primary Outcome Measures:

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:

•Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment

Estimated Enrollment:	225
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2012

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490321

Contacts

Contact: Helene Zintak	973-426-5995	helene.zintak@ventracor.com
Contact: Frances McNamara	973-426-5988	frances.mcnamara@ventracor.com

Show 27 Study Locations

Sponsors and Collaborators

Ventracor

International Center for Health Outcomes and Innovation Research

More Information

No publications provided

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

Keywords provided by Ventracor:

VentrAssistTM
LVAD
End-stage heart failure
Cardiomyopathy

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Cardiomyopathies

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases
Cardiomyopathies

ClinicalTrials.gov processed this record on May 07, 2009