NCT06465459

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

ESCALLE : Post-marketing Clinical Study of the LambrE System for Left Auricle Closure

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: French Cardiology Society · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	LAMBRE device implantation	LAMBRE device implantation

Timeline

• Start date: 2024-06-10
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-06-18
• Last updated: 2026-03-02

Locations

1 site across 1 country: France