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Clinical Trials in France / NCT06465459
Recruiting Observational

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

NCT06465459 · tracked via the Priya Life Science France tracker
Sponsor
French Cardiology Society
Phase
Observational
Started
2024-06-10
Last updated
2026-03-02

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

LAMBRE device implantation

LAMBRE device implantation: LAMBRE device implantation

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Cardiologique de Haut Lévêque Pessac France Recruiting

More French Cardiology Society trials in France

MULTIVALVE : A Prospective Multicentre Study of Multiple and Mixed Valvular Heart Disease Recruiting
French Hypertrophic Cardiomyopathy Observatory Recruiting
Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery Recruiting
French Registry of Acute ST-elevation or Non-ST-elevation Myocardial Infarction 2015 Active, not recruiting
Assessment of the Association Between Sleep Disorders Detected by a Simplified Questionnaire and Cardiovascular Diseases Recruiting

Other trials for the same condition

CHAMPION-AF Clinical Trial Active, not recruiting
PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation Recruiting
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation Active, not recruiting
Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal Atrial Fibrillation (AF) Ablation Recruiting
Modified Left Atrial Maze Procedure for Concomitant AF Ablation Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06465459 on ClinicalTrials.gov ↗ ← All trials in France