Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform
NCT ID: NCT03697980
Last Updated: 2023-12-04
Study Results
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View full resultsBasic Information
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COMPLETED
136 participants
OBSERVATIONAL
2019-01-17
2022-02-10
Brief Summary
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The Apogee study is conducted within Medtronic's Product Surveillance Platform.
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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HVAD Left Ventricular Assist Device
Device: HeartWare Ventricular Assist Device
Other Names:
HVAD 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).
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
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
AdventHealth
Orlando, Florida, United States
Northwestern University
Chicago, Illinois, United States
Cardiac Surgery Clinical Research Center
Oak Lawn, Illinois, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
University of Louisville
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
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
NYU Langone Medical Center
New York, New York, United States
Columbia University
New York, 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 St. Vincent Medical Center
Portland, Oregon, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 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
University of Utah
Salt Lake City, Utah, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Commonwalth University Health System
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Apogee
Identifier Type: -
Identifier Source: org_study_id