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

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Procedure: LAMBRE device implantation

• Registration Number: NCT06465459
• Lead Sponsor: French Cardiology Society

Brief 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

Not available

Study Timeline

• Study First Submitted: 2024-05-29
• Study Start: 2024-06-10
• Study First Submitted QC: 2024-06-12
• Study First Posted: 2024-06-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2027-06-10
• Study Completion: 2027-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients scheduled for percutaneous left atrial closure with Lambre device implantation.	LAMBRE device implantation	-

Primary Outcome Measures

Name	Time	Method
To assess the incidence of first cardiovascular event in patients implanted with a left atrial closure device.	during procedure and a follow-up lasting 12 months in a population having had a installation of an Lambre 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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of the device	at 1 year after implantation	The comparison of the frequency of ischemic cerebral or systemic accidents to the theoretical predicted value
Description of bleeding complications not related to the device or procedure	during procedure and a follow-up lasting 12 months in a population having had a inmplantation of an Lambre device	Percentage of patients who experienced at least one bleeding complication unrelated to the device or procedure during the entire study
Description of the population and centers	at baseline	demographic and clinical characteristics of patients
To evaluate the tolerance of the procedure and the device	at 1 year	Percentage of major and/or life-threatening bleeding complications and total percentage of complications related or potentially related to the procedure or device
Description of antithrombotic treatments prescribed following implantation of the device	at inclusion, at the pre-discharge examination (up to 3 days), at 30 days, 3 months and 12 months after implantation	Percentage of patients on injectable or oral anticoagulants and on antiplatelet agents at the different follow-up times, Percentage of patients on injectable or oral anticoagulants at different follow-up times, Percentage of patients on antiplatelet agents in mono or dual therapy at the different follow-up times, Average duration of anticoagulant and antiplatelet treatments.

Trial Locations

Locations (1)

Hôpital Cardiologique de Haut Lévêque; 🇫🇷 Pessac, France