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Clinical Trials in Spain / NCT07260474
Recruiting Not applicable

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

NCT07260474 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundación EPIC
Phase
Not applicable
Started
2024-05-05
Last updated
2026-10-07

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Patients implanted with Amplatzer Amulet™Patients implanted with LAmbre™

Patients implanted with Amplatzer Amulet™: Left atrial appendage closure with the Amplatzer Amulet™ device. The procedure will be performed according to standard practice using the manufacturer's instructions for use.

Patients implanted with LAmbre™: Left atrial appendage closure with the LAmbre™ device. The procedure will be performed according to standard practice using the manufacturer's instructions for use.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • EFFICACY: Device success — 3 months
    Percentage Device success defined as: Successful deployment and stable implantation of the assigned device within the left atrial appendage during the index procedure and no crossover to the alternative device and effective closure of the appendage with a residual leak ≤5 mm as assessed by TEE(Transesophageal Echocardiography) or CCTA (Cardiac Computed Tomography Angiography) at 90 days.

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitario La Paz Fuencarral-El Pardo Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07260474 on ClinicalTrials.gov ↗ ← All trials in Spain