Actively Recruiting
Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure
Led by French Cardiology Society · Updated on 2026-03-02
220
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
Sponsors
F
French Cardiology Society
Lead Sponsor
L
Lifetech Scientific (Shenzhen) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Minor patient
- Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or safeguard of justice)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Cardiologique de Haut Lévêque
Pessac, France, 33600
Actively Recruiting
Research Team
D
Dr Xavier IRIART
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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