Using the LAMBRE device to close the left auricle in patients with atrial fibrillation
ESCALLE : Post-marketing Clinical Study of the LambrE System for Left Auricle Closure
French Cardiology Society · NCT06465459
This study tests whether the LAMBRE device can help people with atrial fibrillation who can’t take blood thinners by closing a part of the heart to prevent strokes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | French Cardiology Society (other) |
| Locations | 1 site (Pessac) |
| Trial ID | NCT06465459 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the use of the LAMBRE system for left atrial appendage closure in patients with non-valvular atrial fibrillation who are at high risk for thromboembolic events and have contraindications to anticoagulation therapy. The study aims to assess the effectiveness of this device in preventing strokes caused by thrombus formation in the left atrium. Participants will be monitored for outcomes related to the closure procedure and any associated complications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with non-valvular atrial fibrillation and a CHA2DS2-VASc score of 4 or higher who cannot take anticoagulants.
Not a fit: Patients who are minors or those who can’t provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer alternative to anticoagulation therapy for patients at high risk of stroke due to atrial fibrillation.
How similar studies have performed: Other studies have shown success with similar left atrial appendage closure devices, indicating a promising approach for this patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Pessac
- Hôpital Cardiologique de Haut Lévêque — Pessac, France (RECRUITING)
Study contacts
- Principal investigator: Xavier IRIART — Hôpital Cardiologique de Haut Lévêque
- Study coordinator: Dr Xavier IRIART
- Email: escalle@sfcardio.fr
- Phone: (+33) 1 44 90 70 29
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, non-valvular atrial fibrillation, atrial fibrillation, LAMBRE system