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NCT07260474Recruiting

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

Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure: the CALAMBRE Randomized Clinical Trial

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
21 Nov 2025
Start date
5 May 2024
Primary completion date
31 Dec 2026
Lead sponsor
Fundación EPIC
NCT number
NCT07260474

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From 5 May 2024 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 concurrent participation in another investigational study that may affect study results.

Other illness

  • Patient life expectancy \<1 year (terminal illness).
  • 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.

Other

  • (MUST NOT MEET ANY EXCLUSION CRITERIA)
  • Patient with inability or unwillingness to comply with the study protocol or follow-up requirements.
  • Patient pregnant or breastfeeding women.

Who the study is looking for

  • (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..

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitario La Paz
Coordinator of this site? Confirm its status
Fuencarral-El PardoSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.