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

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

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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: HeartMate II (HMII)
* Drug: Warfarin
* Drug: acetylsalicylic acid (ASA) therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subject is receiving the HM II per standard of care (SOC) in accordance with the FDA approved indications for use Subject is ≥ 50 years of age Subject is receiving the HM II as their first LVAD Subject or legally authorized representative (LAR) has signed an informed consent form (ICF). Exclusion Criteria Existence of ongoing mechanical circulatory support (MCS) other than intra-aortic balloon pump or Impella® devices Participation in any other clinical investigation(s) involving an MCS device, or an investigation(s) that is likely to confound study results or affect study outcome Antiplatelet therapy is mandated for other conditions, in particular: a) recent coronary artery stenting (≤ 6 months), b) carotid artery disease, and c) other conditions where the investigator is not comfortable leaving subjects off-ASA or starting ASA post LVAD implantation. In situations where the investigator is uncertain, the Steering Committee can provide recommendation to the investigator as needed. Subjects in whom heart transplantation is expected in ≤ 6 months Subjects with a known ASA allergy

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant | Device: HeartMate II (HMII)<br>* Left Ventricular Assist Device<br>Drug: Warfarin<br>* (INR Target 2.0-2.5, median 2.25, per standard of patient care)<br>* Other names: Coumadin;|
| Active Comparator: Control Arm<br>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 | Device: HeartMate II (HMII)<br>* Left Ventricular Assist Device<br>Drug: Warfarin<br>* (INR Target 2.0-2.5, median 2.25, per standard of patient care)<br>* Other names: Coumadin;Drug: acetylsalicylic acid (ASA) therapy<br>* (81mg/day)<br>* Other names: Aspirin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 6 months post initial implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HeartMate II (HMII), Left Ventricular Assist Device (LVAD)