Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure (NCT07260474) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure
200 participantsStarted 2026-01-30
Plain-language summary
Clinical investigation with CE-marked medical devices, multicenter, prospective, randomized and controlled. Patients with non-valvular atrial fibrillation at high embolic risk and with at least one high bleeding risk criterion according to the Munich consensus document will be randomized to left atrial appendage closure with either the Amplatzer Amulet™ or the LAmbre™ device. The study is designed to compare the efficacy and safety of both devices regarding successful implantation, effective appendage closure, and clinical outcomes at follow-up.
Who can participate
Age range
18 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:
(MUST MEET ALL INCLUSION CRITERIA)
* Patient with aged ≥18 years AND;
* Patient have non-valvular atrial (NVAF) with a CHA2DS2-VASc score ≥2, and presented at least one high-bleeding-risk criterion according to the Munich consensus document AND;
* Patient are required to undergo preprocedural TEE / CCTA to confirm the absence of LAA thrombus and to ensure that LAA anatomy is suitable for closure with either device.
* Patient who has been informed of the characteristics of the study and has provided written informed consent..
Exclusion Criteria:
(MUST NOT MEET ANY EXCLUSION CRITERIA)
* Patient life expectancy \<1 year (terminal illness).
* Patient with requirement for oral anticoagulation therapy for any indication other than non-valvular atrial fibrillation.
* Patient with prior surgical ligation or obliteration of the left atrial appendage.
* Patient with history of allergic reaction or intolerance to any material used in the study devices or to any of the antithrombotic agents required post-procedure.
* Patient with active systemic infection.
* Patient with concurrent participation in another investigational study that may affect study results.
* Patient with inability or unwillingness to comply with the study protocol or follow-up requirements.
* Patient pregnant or breastfeeding women.
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.