Amulet vs LAmbre: Left Atrial Appendage Closure in NVAF patients at high bleeding risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter, prospective, randomized trial, adults with non-valvular atrial fibrillation at high embolic and bleeding risk are assigned to left atrial appendage closure using either the Amplatzer Amulet or the LAmbre device. The trial compares implantation success, the degree of appendage closure, and clinical outcomes during follow-up. All participants undergo preprocedural imaging to confirm suitability for closure and absence of LAA thrombus. CE-marked devices are used under controlled, ethical conditions with informed consent and standard safety monitoring.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario La Paz
  Fuencarral-El Pardo, Spain Recruiting

Study contacts

• Study coordinator: BORJA Rivero-Santana, MD, PhD
• Email: borja.riversa@gmail.com
• Phone: 0034696170677

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.