DOT HeartMate 3 Study (NCT04974684) | Clinical Trial Compass
CompletedNot Applicable
DOT HeartMate 3 Study
Czechia45 participantsStarted 2022-04-01
Plain-language summary
A prospective, single-center, randomized controlled trial of the feasibility and safety of apixaban in HeartMate 3 patients.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Evaluation of Hemocompatibility Related Adverse Events During Apixaban Use With the HeartMate 3 LVAS
Timeframe: 6 months
Trial details
NCT IDNCT04974684
SponsorInstitute for Clinical and Experimental Medicine