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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Ventracor.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
International Center for Health Outcomes and Innovation Research
Information provided by:
Ventracor
ClinicalTrials.gov Identifier:
NCT00490321
First received: June 20, 2007
Last updated: September 4, 2009
Last verified: September 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the VentrAssistTM Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy

Resource links provided by NLM:

U.S. FDA Resources

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

  Show 27 Study Locations
Sponsors and Collaborators
Ventracor
International Center for Health Outcomes and Innovation Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00490321     History of Changes
Other Study ID Numbers: CLP 12082
Study First Received: June 20, 2007
Last Updated: September 4, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Ventracor:
VentrAssistTM
LVAD
End-stage heart failure
Cardiomyopathy

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013