Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo
This clinical investigation is a prospective, randomized, double-blinded, placebo-controlled study of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
628
Subjects will undergo Heartmate 3 LVAD implant prior to randomization
Subjects will be randomized to either Placebo or Aspirin post implant.
Subjects will be randomized to either Placebo or Aspirin post implant
Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events
The primary end point was a composite of survival free of non-surgical major hemocompatibility related adverse events (specifically stroke, pump thrombosis, major non-surgical bleeding, and arterial peripheral thromboembolism) at 1-year post implant.
Time frame: 12 Months
Rates of Non-surgical Major Hemorrhagic Events
The rate of non-surgical hemorrhagic events were compared between the two arms of the study. Non-surgical Major Hemorrhagic events: Hemorrhagic event rate per patient year was calculated by dividing all non-surgical bleeding events and hemorrhagic stroke events by the cumulative years of study exposure.
Time frame: Through Study Completion with a Median Follow up of 14 Months
Rates of Bleeding Events
The bleeding rate was calculated by dividing the number of bleeding events by the cumulative duration of study exposure (years of support).
Time frame: Through Study Completion with a Median Follow up of 14 Months
Rates of Non-surgical Major Thrombotic Events
The rates of non-surgical major thrombotic events was compared between the two arms of the study. The thrombotic event rate per patient year was calculated by dividing the number of non-surgical ischemic strokes, pump thrombosis and arterial peripheral thromboembolic events by the cumulative years of study exposure
Time frame: Through Study Completion with a Median Follow up of 14 Months
Rates of Stroke
The stroke rate was calculated based on the number of strokes experienced by subjects, 14 days or more after device implant, and while on their treatment assignment, divided by the cumulative duration of study exposure (years of support).
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Baptist Health Medical Center
Little Rock, Arkansas, United States
University of California, San Diego
La Jolla, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Sharp Memorial Hospital
San Diego, California, United States
California Pacific Medical Center - Van Ness Campus
San Francisco, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Miami Transplant Institute - Jackson Memorial
Miami, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
...and 41 more locations
Time frame: Through Study Completion with a Median Follow up of 14 Months
Survival Rates
The overall survival rate was analyzed using a Kaplan-Meier analysis and the treatment groups were compared using log-rank test. Survival was calculated starting at 14 days post implant.
Time frame: 24 Months
Risk of Non-Surgical Bleeding Events
Risk of non-surgical bleeding events was analyzed using a Kaplan-Meier analysis. The treatment groups were compared using a log-rank test.
Time frame: 24 Months