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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-30

Study Completion Date

2027-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amplatzer Amulet™left atrial appendage occluder

Group Type OTHER

Patients implanted with Amplatzer Amulet™

Intervention Type DEVICE

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.

LAmbre™left atrial appendage occluder

Group Type OTHER

Patients implanted with LAmbre™

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No