DOT HeartMate 3 Study

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

A prospective, single-center, randomized controlled trial of the feasibility and safety of apixaban in HeartMate 3 patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute for Clinical and Experimental Medicine
• Treatments: Apixaban

Criteria

Inclusion Criteria:

• The patient has been implanted with HeartMate 3 LVAS

• The patient is, at a minimum, 3 months post HeartMate 3 implant

• The patient is stable, ambulatory, and has been discharged home

• The patient provides written informed consent before any clinical investigation related procedure

Exclusion Criteria:

• Non-compliance with anticoagulation and antiplatelet medication, in the opinion of the investigator

• Weight ≤ 60 kgs. or age ≥ 80 years

• Poor kidney function with serum creatinine ≥ 221umol/L or creatinine clearance < 0.042 mL/s, or the need for chronic renal replacement therapy

• Total bilirubin > 43 umol/L, shock liver, or biopsy-proven liver cirrhosis

• Absence of an informed consent

• Presence of any mechanical prosthetic valve or any ancillary circulatory assist device system (other than the HM3)

• Recent history of cardioembolic stroke

• Hemodynamically significant carotid arteries stenosis (documented by imaging investigation not older than 12 months)

• Need for antiplatelet therapy for reasons other than LVAD therapy

• Major HRAE event after HeartMate 3 index hospitalization discharge

• Known history of hyper- or hypo- coagulable disorder

• Anti-phospholipid syndrome positive patients with documented history of thrombotic/thromboembolic events

• Known hypersensitivity or allergy to apixaban or aspirin

• The patient is involved in another interventional study or any study that could potentially affect the functioning of the HM3 LVAD or the therapeutic effect of any of the study anticoagulants (warfarin, apixaban or aspirin), or could potentially confound the study results

• The patient is currently pregnant, breastfeeding, or intending to get pregnant during the study

• Presence of other anatomic or comorbid conditions, or other medical, social, non-compliance 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.