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VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial

This study has been completed.
Sponsor:
Collaborator:
International Center for Health Outcomes and Innovation Research
Information provided by:
Ventracor
ClinicalTrials.gov Identifier:
NCT00490347
First received: June 20, 2007
Last updated: January 15, 2008
Last verified: January 2008
History of Changes
  Purpose

The purpose of this trial is to determine the safety and feasibility of the VentrAssist LVAD in providing circulatory support for patients who require an LVAD as a bridge to cardiac transplantation.


Condition Intervention Phase
End-Stage Heart Failure
Cardiomyopathies
 Device: VentrAssist Left Ventricular Assist Device
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Feasibility Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ventracor:

Primary Outcome Measures:
  • Survival

Secondary Outcome Measures:
  • Quality of life
  • Functional status
  • Neurocognitive function

Estimated Enrollment: 30
Study Start Date: July 2005
Study Completion Date: October 2007
  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; more specific criteria are included in the study protocol):

  • Approved and listed for cardiac transplantation.
  • Patient for whom LVAD implantation is planned as a clinically indicated bridge to cardiac transplantation.

Exclusion Criteria(The following are general criteria; more specific criteria are included in the study protocol):

  • Presence of heart conditions that would contraindicate LVAD implantation by adversely affecting patient survival or LVAD function.
  • Primary coagulopathy or platelet disorder; contraindication to anticoagulant or anti-platelet agents.
  • Presence of any mechanical circulatory support other than intra-aortic balloon pump.
  • Therapy with an investigational intervention at the time of screening.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490347

Locations
United States, Maryland
University of Maryland Medical Center - Baltimore
Baltimore, Maryland, United States, 21201
United States, Minnesota
University of Minnesota Medical Center - Fairview
Minneapolis, Minnesota, United States, 55455
United States, New York
New York Presbyterian Medical Center - Columbia
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Ventracor
International Center for Health Outcomes and Innovation Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00490347     History of Changes
Other Study ID Numbers: CLP070012
Study First Received: June 20, 2007
Last Updated: January 15, 2008
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 23, 2013