AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure

RecruitingNAAges 18 Years - anyAllFundación EPIC
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
💊

What it tests

  • Patients implanted with Amplatzer Amulet™
  • Patients implanted with LAmbre™
📍

Where

1 site
Hospital Universitario La Paz
Fuencarral-El Pardo, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy