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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Ventracor.
Recruitment status was:  Active, not recruiting
International Center for Health Outcomes and Innovation Research
Information provided by:
Ventracor Identifier:
First received: June 20, 2007
Last updated: September 4, 2009
Last verified: September 2009

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
Device: VentrAssistTM Left Ventricular Assist Device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00490321

  Show 27 Study Locations
Sponsors and Collaborators
International Center for Health Outcomes and Innovation Research
  More Information Identifier: NCT00490321     History of Changes
Other Study ID Numbers: CLP 12082
Study First Received: June 20, 2007
Last Updated: September 4, 2009

Keywords provided by Ventracor:
End-stage heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on May 24, 2017