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

NCT07260474 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-12-03

No results posted yet for this 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.

Conditions

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Fundación EPIC

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2026-12-31
Completion
2027-01-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07260474 on ClinicalTrials.gov