Print

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.