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

French Cardiology Society

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Procedure: LAMBRE device implantation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06465459

2024-A00420-47

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient requiring a left atrial exclusion procedure according to the recommendations by 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 criteria

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

Trial design

220 participants in 1 patient group

Patients scheduled for percutaneous left atrial closure with Lambre device implantation.

Treatment:

Procedure: LAMBRE device implantation

Sponsors of this trial

Lead Sponsor

French Cardiology Society

Collaborating Sponsor

LifeTech Scientific