Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform

CompletedOBSERVATIONAL
Enrollment

136

Participants

Timeline

Start Date

January 17, 2019

Primary Completion Date

February 10, 2022

Study Completion Date

February 10, 2022

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 (33)

10016

NYU Langone Medical Center, New York

10032

Columbia University, New York

15213

University of Pittsburgh Medical Center UPMC Presbyterian, Pittsburgh

21201

University of Maryland Medical Center, Baltimore

21287

The Johns Hopkins Hospital, Baltimore

23298

Virginia Commonwalth University Health System, Richmond

23507

Sentara Norfolk General Hospital, Norfolk

32804

AdventHealth, Orlando

37232

Vanderbilt University Medical Center, Nashville

40202

University of Louisville, Louisville

45219

The Lindner Christ Hospital, Cincinnati

48202

Henry Ford Health System, Detroit

55905

Mayo Clinic Rochester, Rochester

60453

Cardiac Surgery Clinical Research Center, Oak Lawn

60611

Northwestern University, Chicago

63110

Washington University School of Medicine, St Louis

66160

The University of Kansas Medical Center, Kansas City

72205

Saint Vincent Heart Clinic Arkansas, Little Rock

74104

Oklahoma Heart Institute, Tulsa

75390

University of Texas Southwestern Medical Center, Dallas

77030

Baylor College of Medicine, Houston

Houston Methodist Hospital, Houston

University of Texas Health Sciences Center, Houston

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 St. Vincent Medical Center, Portland

98195

University of Washington Medical Center, Seattle

94305-5330

Stanford University Hospital, Stanford

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

43210-1240

The Ohio State University Wexner Medical Center, Columbus

All Listed Sponsors
lead

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

NCT03697980 - Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform | Biotech Hunter | Biotech Hunter