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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ACTIVE_NOT_RECRUITING
300 participants
OBSERVATIONAL
2018-10-31
2026-04-30
Brief Summary
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The Destination Therapy Post Approval Study (DT PAS) is conducted within Medtronic's Product Surveillance Platform.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients implanted with HVAD System
Patients intended to be implanted with a HVAD for use as destination therapy are eligible for enrollment into the DT PAS and must be consented for the study prior to the HVAD implant.
HeartWare Ventricular Assist Device
The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD).
Interventions
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HeartWare Ventricular Assist Device
The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is intended to receive or be treated with a HeartWare HVAD System for use as destination therapy
* Patient is consented prior to the HVAD implant procedure
Exclusion Criteria
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e., no required intervention that could affect interpretation of all-around product safety and or effectiveness)
* Patient less than 18 years of age.
* Patient with previous support by long-term mechanical circulatory support (MCS), not including temporary mechanical circulatory support.
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Locations
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Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, United States
University of California San Diego
San Diego, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
Stanford University Hospital
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
University of Miami
Coral Gables, Florida, United States
Mayo Clinic (Jacksonville FL)
Jacksonville, Florida, United States
AdventHealth
Orlando, Florida, United States
University of South Florida Health
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Loyola University
Maywood, Illinois, United States
Advocate Christ Medical Center (Cardiac Surgery Clinical Research Center)
Oak Lawn, Illinois, United States
Saint Vincent Medical Group
Indianapolis, Indiana, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
University of Louisville Hospital
Louisville, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
NYU Langone Medical Center
New York, New York, United States
Columbia University
New York, New York, United States
Westchester Medical Center
Valhalla, New York, United States
The Lindner Christ Hospital
Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
PennState Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Texas Health Sciences Center
Houston, Texas, United States
Methodist Hospital San Antonio
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Commonwealth University Health System
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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DT PAS
Identifier Type: -
Identifier Source: org_study_id
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