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Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure

NCT06465459 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2026-03-02

No results posted yet for this study

Summary

Atrial fibrillation (AF) is responsible for 15-20% of ischaemic strokes. These events are often caused by thrombus formation in the left atrium. Thromboembolic risk in AF is primarily prevented by oral anticoagulation. However, this drug-based approach has a number of limitations, the most important of which are compliance problems and, above all, the risk of haemorrhagic complications, some of which are potentially serious. Left atrial appendage closure is a therapeutic alternative for the prevention of cardioembolic risk in cases where anticoagulation is clearly contraindicated.

The CNEDiMTS opinion of 12 March 2019 defines that the LAMBRE, LIFETCH prosthesis, a device for transcatheter closure of the left atrial appendage, is authorised for the prevention of thromboembolic events in patients with non-valvular atrial fibrillation at high risk of thromboembolic events with a CHA2DS2-VASc score ≥ 4 and a formal and permanent contraindication to anticoagulants (validated by a multidisciplinary committee).

LAMBRE prosthesis in France are subject to a review of the results by the CNEDIMTS committee. Among the criteria analysed regarding the efficacy and safety of the device implantation, the result regarding the migration rate of the LAMBRE device will be one of the criteria enabling the Commission to decide on the appropriateness of the renewal of the registration.

Conditions

Interventions

PROCEDURE

LAMBRE device implantation

LAMBRE device implantation

Sponsors & Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    collaborator INDUSTRY

  • French Cardiology Society

    lead OTHER

Principal Investigators

  • Xavier IRIART · Hôpital Cardiologique de Haut Lévêque

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-10
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • France

Study Locations

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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 NCT06465459 on ClinicalTrials.gov