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

Fundación EPIC

Status: Not yet enrolling

Conditions: Coronary Artery Disease

Treatments: Device: Patients implanted with Amplatzer Amulet™; Device: Patients implanted with LAmbre™

Study type: Interventional

Funder types: Other

Identifiers

NCT07260474

EPIC48-CALAMBRE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Amplatzer Amulet™left atrial appendage occluder

Other group

Treatment:

Device: Patients implanted with Amplatzer Amulet™

LAmbre™left atrial appendage occluder

Other group

Treatment:

Device: Patients implanted with LAmbre™