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VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial

This study has been completed.
International Center for Health Outcomes and Innovation Research
Information provided by:
Ventracor Identifier:
First received: June 20, 2007
Last updated: January 15, 2008
Last verified: January 2008
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
Device: VentrAssist Left Ventricular Assist Device
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

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

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; 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.
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Please refer to this study by its identifier: NCT00490347

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
International Center for Health Outcomes and Innovation Research
  More Information Identifier: NCT00490347     History of Changes
Other Study ID Numbers: CLP070012
Study First Received: June 20, 2007
Last Updated: January 15, 2008

Keywords provided by Ventracor:
End-stage heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on April 26, 2017