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

Last updated: February 27, 2026
Sponsor: French Cardiology Society
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Cardiac Disease

Atrial Fibrillation

Treatment

LAMBRE device implantation

Clinical Study ID

NCT06465459
2024-A00420-47
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient requiring a left atrial exclusion procedure according to the recommendationsby the CNEDiMTS and HAS using the LAMBRE device

  • Age ≥18 years

  • Patient has been informed of the nature of the study and agrees to participate

Exclusion

Exclusion Criteria:

  • Minor patient

  • Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or safeguard of justice)

Study Design

Total Participants: 220
Treatment Group(s): 1
Primary Treatment: LAMBRE device implantation
Phase:
Study Start date:
June 10, 2024
Estimated Completion Date:
December 31, 2027

Study Description

This is a non-interventional, prospective and retrospective national multicentre study.

Connect with a study center

  • Hôpital Cardiologique de Haut Lévêque

    Pessac, 33600
    France

    Site Not Available

  • Hôpital Cardiologique de Haut Lévêque

    Pessac 2987805, 33600
    France

    Active - Recruiting

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