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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
Left Ventricular Assist Device
(INR Target 2.0-2.5, median 2.25, per standard of patient care)
(81mg/day)
Safety Endpoint: % of Patients With Non-surgical Bleeding at 6 Months Post HeartMate II Implant
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).
Time frame: 6 months post initial implantation
Efficacy Endpoint: % of Patients With Thromboembolic Events at 6 Months Post HeartMate II Implant
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.
Time frame: 6 months post initial implantation
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