VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial
NCT ID: NCT00483197
Last Updated: 2009-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
140 participants
INTERVENTIONAL
2007-06-30
2010-06-30
Brief Summary
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Detailed Description
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The VentrAssist LVAD is a centrifugal flow pump. Its small size and mechanical simplicity offers benefits not available with currently approved LVADs, including facilitating a more limited implantation procedure, which could reduce surgical morbidity and mortality.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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VentrAssistTM Left Ventricular Assist Device
Eligibility Criteria
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Inclusion Criteria
* Patient for whom LVAD implantation is planned as a clinically indicated bridge to cardiac transplantation.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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International Center for Health Outcomes and Innovation Research
OTHER
Ventracor
INDUSTRY
Responsible Party
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Washington Hospital/Barnes Jewish Hospital
Locations
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University of Alabama
Birmingham, Alabama, United States
Mayo Clinic
Phoenix, Arizona, United States
University of Florida
Gainesville, Florida, United States
Jackson Memorial
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
St. Vincent's
Indianapolis, Indiana, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Mount Sinai Hospital
New York, New York, United States
Columbia University
New York, New York, United States
Rochester Medical Center University
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Methodist Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Fairfax (Inova) Hospital
Falls Church, Virginia, United States
University of Washington
Seattle, Washington, United States
Sacred Heart Medical Center
Spokane, Washington, United States
University of Wisconsin Hospital
Madison, Wisconsin, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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CLP 06005
Identifier Type: -
Identifier Source: org_study_id
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