Summary

for people ages 50 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Details

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 TE events.

Keywords

Heart Failure HeartMate II (HMII) Left Ventricular Assist Device (LVAD) Warfarin Aspirin acetylsalicylic acid (ASA) therapy

Eligibility

You can join if…

Open to people ages 50 years and up

  • 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).

You CAN'T join if...

  • Existence of ongoing mechanical circulatory support (MCS) other than intra-aortic balloon pump or Abiomed 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

Locations

  • University of California at San Francisco
    San Francisco California 94131 United States
  • Ronald Reagan UCLA Medical Center
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
St. Jude Medical
ID
NCT02836652
Phase
Phase 4
Study Type
Interventional
Last Updated