Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy

PHASE4CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

February 21, 2019

Study Completion Date

July 18, 2019

Conditions
Heart Failure
Interventions
DEVICE

HeartMate II (HMII)

Left Ventricular Assist Device

DRUG

Warfarin

(INR Target 2.0-2.5, median 2.25, per standard of patient care)

DRUG

acetylsalicylic acid (ASA) therapy

(81mg/day)

Trial Locations (35)

10032

New York Presbyterian Hospital/Columbia University, New York

10467

Montefiore Medical Center, The Bronx

10595

Westchester Medical Center, Valhalla

11790

Stony Brook University Medical Center, Stony Brook

14642

University of Rochester Medical Center, Rochester

19107

Thomas Jefferson University Hospital, Philadelphia

19140

Temple University Hospital, Philadelphia

20010

Washington Hospital Center, Washington D.C.

27599

University of North Carolina at Chapel Hill, Chapel Hill

29203

Palmetto Health Richland, Columbia

30309

Piedmont Hospital, Atlanta

32610

Shands at the University of Florida, Gainesville

32803

Florida Hospital, Orlando

35249

University of Alabama Hospital at Birmingham (UAB), Birmingham

38120

Baptist Memorial Hospital, Memphis

43210

Ohio State University, Columbus

45219

Christ Hospital, Cincinnati

46240

St. Vincent Hospital, Indianapolis

48202

Henry Ford Hospital, Detroit

53215

St. Luke's Medical Center, Milwaukee

55455

University of Minnesota Medical Center Fairview, Minneapolis

55905

Mayo Clinic, Rochester

66160

Kansas University Medical Center, Kansas City

70121

Ochsner Medical Center, New Orleans

73112

Integris Baptist Medical Center, Oklahoma City

75246

Baylor University Hospital, Dallas

77030

Memorial Hermann, Houston

78705

Seton Medical Center, Austin

90095

Ronald Reagan UCLA Medical Center, Los Angeles

92123

Sharp Memorial Hospital, San Diego

94131

University of California at San Francisco, San Francisco

97225

Providence St. Vincent, Portland

02111

Tufts Medical Center, Boston

H1T 1C8

Institut de Cardiologie de Montreal (Montreal Heart Inst.), Montreal

G1V 4G5

Institut de Cardiologie de Quebec (Hôpital Laval), Québec

Sponsors
All Listed Sponsors
lead

Abbott Medical Devices

INDUSTRY