Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo

Official Title

Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study

Details

This clinical investigation is a prospective, randomized, double-blinded, placebo-controlled study of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo.

Keywords

Heart Failure ventricular assist device LVAD aspirin LVAD Implant Aspirin 100mg

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Subject will receive the HeartMate 3 per standard of care (SOC) in accordance with the approved indications for use in the country of implant.
  2. Subject will receive the HeartMate 3 as their first durable VAD.
  3. Subject must provide written informed consent prior to any clinical investigation related procedure.
  4. In female patients of child bearing capability, subject will not be currently pregnant or breastfeeding and on appropriate contraception.

You CAN'T join if...

  1. Post-implant additional temporary or permanent mechanical circulatory support (MCS).
  2. Investigator mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent).
  3. Patients who are nil per os (NPO) post-implant through day 7.
  4. Subjects with a known allergy to acetylsalicylic acid (aspirin).
  5. Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome.
  6. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Locations

  • University of California, San Diego
    La Jolla California 92037 United States
  • Sharp Memorial Hospital
    San Diego California 92123 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT04069156
Study Type
Interventional
Participants
At least 628 people participating
Last Updated