VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy
NCT ID: NCT00490321
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
225 participants
INTERVENTIONAL
2007-06-30
2012-06-30
Brief Summary
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This is a multi-center, prospective, randomized, controlled clinical trial, which is comprised of two independent modules.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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VentrAssistTM Left Ventricular Assist Device
Eligibility Criteria
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Inclusion Criteria
* LVEF \<=25%
* Stage D heart failure
* Ineligible for cardiac transplantation
* Treated with standard heart failure therapy
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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International Center for Health Outcomes and Innovation Research
OTHER
Ventracor
INDUSTRY
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
St. Vincent's
Indianapolis, Indiana, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
University of Minnesota
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
Ohio State University
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
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 12082
Identifier Type: -
Identifier Source: org_study_id
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