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

French Cardiology Society220 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

220

Conditions

Atrial Fibrillation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

To assess the incidence of first cardiovascular event in patients implanted with a left atrial closure device.

the occurrence of one of the following events: ischaemic stroke, systemic embolism, rate of device migration and death of cardiovascular or unexplained origin occurring in patients implanted with a left atrial closure device.

Time frame: during procedure and a follow-up lasting 12 months in a population having had a installation of an Lambre device