Studies the LAMBRE device for closing the left atrial appendage in atrial fibrillation
Studies the LAMBRE device in adults with atrial fibrillation who cannot take blood thinners.
Key facts
- Who runs it
- French Cardiology Society
- Where
- Pessac, FranceSee the site
- Trial code
- Registry title
- Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure
- Status
- Recruiting
- People taking part
- 220 people, planned
- Started
- 10 Jun 2024
- Expected to end
- Dec 2027
- Type of study
- Observational
- Treatments tested
- LAMBRE device implantation
- Record updated
- 2 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with atrial fibrillation who need the left atrial appendage closed with the LAMBRE device, following the French health authority recommendations.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Atrial fibrillation needing closure of the left atrial appendage (the small pouch of the heart's upper chamber) with the LAMBRE device.
Main reasons for not taking part
- Under 18 years old
- Refuses to take part
- Unable to give informed consent, for example a person under guardianship or curatorship
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- Minor patient
- Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or safeguard of justice)
Where in France
- Hôpital Cardiologique de Haut LévêquePessac, FranceContact: Xavier IRIARTTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- Patients scheduled for percutaneous left atrial closure with Lambre device implantation.
Treatment: LAMBRE device implantation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- ESCALLE : Post-marketing Clinical Study of the LambrE System for Left Auricle Closure
- Plain-language title
- Studies the LAMBRE device for closing the left atrial appendage in atrial fibrillationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 2 March 2026