NCT06465459Recruiting
Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure
ESCALLE : Post-marketing Clinical Study of the LambrE System for Left Auricle Closure
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 220 (estimated)
- First submitted
- 29 May 2024
- Start date
- 10 Jun 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- French Cardiology Society
- Diseases
- Atrial fibrillation
- NCT number
- NCT06465459
What you commit to
- Study type: Observational
- Planned participants: 220
- From 10 Jun 2024 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Minor patient
- Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or safeguard of justice)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Cardiologique de Haut Lévêque Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.