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

Purpose

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.

Condition

  • Heart Failure

Eligibility

Eligible Ages
Over 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment Arm 		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)
    Left Ventricular Assist Device
  • Drug: Warfarin
    (INR Target 2.0-2.5, median 2.25, per standard of patient care)
    Other names:
    • Coumadin
Active Comparator
Control Arm 		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)
    Left Ventricular Assist Device
  • Drug: Warfarin
    (INR Target 2.0-2.5, median 2.25, per standard of patient care)
    Other names:
    • Coumadin
  • Drug: acetylsalicylic acid (ASA) therapy
    (81mg/day)
    Other names:
    • Aspirin

More Details

Status
Completed
Sponsor
Abbott Medical Devices

Study Contact

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.