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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  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.

Exclusion Criteria

  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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Double-blinded, randomized 1:1, active arm versus placebo arm
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Investigator, site, patient, CEC, and core lab are blinded.

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo Arm 		LVAD Patients on the placebo arm will be given placebo medication
  • Device: LVAD Implant
    Subjects will undergo Heartmate 3 LVAD implant prior to randomization
  • Drug: Placebo oral tablet
    Subjects will be randomized to either Placebo or Aspirin post implant
Active Comparator
Active Arm 		LVAD Patients on the active arm will be given 100mg Aspirin
  • Device: LVAD Implant
    Subjects will undergo Heartmate 3 LVAD implant prior to randomization
  • Drug: Aspirin 100mg
    Subjects will be randomized to either Placebo or Aspirin post implant.

More Details

Status
Completed
Sponsor
Abbott Medical Devices

Study Contact

Detailed Description

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.

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.