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

Phase 4

Completed

Interventions: Device: HeartMate II (HMII)
Drug: Warfarin
Drug: acetylsalicylic acid (ASA) therapy

Brief Summary: This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.

Detailed Description: This is a post-market clinical study of HM II patient management practices to be conducted in the United States.

Subjects will be randomized in a 1:1 fashion to the following research drug groups:

1. Treatment Arm: Warfarin (INR target: 2.0-2.5, median: 2.25) + Placebo (1 pill/day)

2. Control Arm: Warfarin (INR target: 2.0-2.5, median: 2.25) + ASA Therapy (81mg/day)

The study will investigate if subjects in the Treatment Arm experience a reduced incidence of non-surgical bleeding, without an increased risk of thromboembolic events.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Treatment Arm	HeartMate II (HMII)	Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant
Control Arm	HeartMate II (HMII)	Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + acetylsalicylic acid (ASA) therapy (81mg/day) post HeartMate II implant
Control Arm	Warfarin	Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + acetylsalicylic acid (ASA) therapy (81mg/day) post HeartMate II implant
Control Arm	acetylsalicylic acid (ASA) therapy	Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + acetylsalicylic acid (ASA) therapy (81mg/day) post HeartMate II implant
Treatment Arm	Warfarin	Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant

Primary Outcome Measures

Name	Time	Method
Safety Endpoint: % of Patients With Non-surgical Bleeding at 6 Months Post HeartMate II Implant	6 months post initial implantation	Composite incidence of non-surgical bleeding at 6 months post initial implantation, including but not limited to gastrointestinal, genitourinary, epistaxis, subdural hematoma, and primary hemorrhagic stroke (not due to ischemic conversion, or due to the treatment of a hemolysis/suspected thrombosis event).
Efficacy Endpoint: % of Patients With Thromboembolic Events at 6 Months Post HeartMate II Implant	6 months post initial implantation	Composite incidence of pump thrombosis and thromboembolic stroke at 6 months post initial implantation, including ischemic stroke, or hemorrhagic stroke due to an ischemic conversion/treatment of hemolysis/pump thrombosis event.

Secondary Outcome Measures

Name	Time	Method

Locations (35): University of Alabama Hospital at Birmingham (UAB)
🇺🇸
Birmingham, Alabama, United States
Ronald Reagan UCLA Medical Center
🇺🇸
Los Angeles, California, United States
Sharp Memorial Hospital
🇺🇸
San Diego, California, United States
University of California at San Francisco
🇺🇸
San Francisco, California, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Shands at the University of Florida
🇺🇸
Gainesville, Florida, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
Piedmont Hospital
🇺🇸
Atlanta, Georgia, United States
St. Vincent Hospital
🇺🇸
Indianapolis, Indiana, United States
Kansas University Medical Center
🇺🇸
Kansas City, Kansas, United States
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University of Alabama Hospital at Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States