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ACTIVE NOT RECRUITING
NCT03681210

Destination Therapy Post Approval Study

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

View on ClinicalTrials.gov

Summary

Medtronic is sponsoring the HeartWare™ HVAD™ Destination Therapy (DT) Post Approval Study (PAS) to further confirm safety and effectiveness of the HeartWare Ventricular Assist Device System (HVAD System) when used as intended, in "real-world" clinical practice. The Destination Therapy Post Approval Study (DT PAS) is conducted within Medtronic's Product Surveillance Platform.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2018-10-31

Completion Date

2026-04

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

DEVICE

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).

Locations (47)

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