Destination Therapy Post Approval Study

Active, not recruitingOBSERVATIONAL
Enrollment

300

Participants

Timeline

Start Date

October 31, 2018

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Chronic Heart Failure
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).

Trial Locations (47)

10016

NYU Langone Medical Center, New York

10032

Columbia University, New York

10595

Westchester Medical Center, Valhalla

15213

University of Pittsburgh Medical Center UPMC Presbyterian, Pittsburgh

17033

PennState Health Milton S. Hershey Medical Center, Hershey

19104

Hospital of the University of Pennsylvania, Philadelphia

21201

University of Maryland Medical Center, Baltimore

21287

The Johns Hopkins Hospital, Baltimore

22908

University of Virginia Medical Center, Charlottesville

23298

Virginia Commonwealth University Health System, Richmond

23507

Sentara Norfolk General Hospital, Norfolk

32224

Mayo Clinic (Jacksonville FL), Jacksonville

32804

AdventHealth, Orlando

33146

University of Miami, Coral Gables

33606

University of South Florida Health, Tampa

37232

Vanderbilt University Medical Center, Nashville

40202

University of Louisville Hospital, Louisville

46260

Saint Vincent Medical Group, Indianapolis

48202

Henry Ford Health System, Detroit

53226

Medical College of Wisconsin, Milwaukee

55455

University of Minnesota, Minneapolis

55905

Mayo Clinic Rochester, Rochester

60153

Loyola University, Maywood

60453

Advocate Christ Medical Center (Cardiac Surgery Clinical Research Center), Oak Lawn

63110

Washington University School of Medicine, St Louis

66160

The University of Kansas Medical Center, Kansas City

68198

University of Nebraska Medical Center, Omaha

72205

Saint Vincent Heart Clinic Arkansas, Little Rock

74104

Oklahoma Heart Institute, Tulsa

75204

Baylor Research Institute Dallas - Baylor University Medical Center (BUMC), Dallas

75389

University of Texas Southwestern Medical Center, Dallas

77030

Baylor College of Medicine, Houston

Houston Methodist Hospital, Houston

University of Texas Health Sciences Center, Houston

78229

Methodist Hospital San Antonio, San Antonio

80045

University of Colorado, Aurora

84132

University of Utah, Salt Lake City

92103

University of California San Diego, San Diego

94143

University of California San Francisco Medical Center, San Francisco

97225

Providence Saint Vincent Medical Center, Portland

98195

University of Washington Medical Center, Seattle

94305-5330

Stanford University Hospital, Stanford

60611-2969

Northwestern University, Chicago

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

45219-2906

The Lindner Christ Hospital, Cincinnati

43210-1240

The Ohio State University Wexner Medical Center, Columbus

All Listed Sponsors
lead

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY