Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
- Conditions
- Heart Failure
- Interventions
- Registration Number
- NCT02836652
- Lead Sponsor
- Abbott Medical Devices
- 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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Trial Locations
- Locations (35)
Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Palmetto Health Richland
🇺🇸Columbia, South Carolina, United States
St. Vincent Hospital
🇺🇸Indianapolis, Indiana, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University of Minnesota Medical Center Fairview
🇺🇸Minneapolis, Minnesota, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of Alabama Hospital at Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Providence St. Vincent
🇺🇸Portland, Oregon, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Shands at the University of Florida
🇺🇸Gainesville, Florida, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
New York Presbyterian Hospital/Columbia University
🇺🇸New York, New York, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
🇨🇦Montreal, Quebec, Canada
Baylor University Hospital
🇺🇸Dallas, Texas, United States
Institut de Cardiologie de Quebec (Hôpital Laval)
🇨🇦Quebec, Canada
Memorial Hermann
🇺🇸Houston, Texas, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Seton Medical Center
🇺🇸Austin, Texas, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States