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 range
18 Years – 80 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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