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

Recruitingn/aAges 18 Years - anyAllFrench Cardiology Society
NCT06465459 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-VA

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📋 Eligibility rules (as published)
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)
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What it tests

  • LAMBRE device implantation
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Where

1 site
Hôpital Cardiologique de Haut Lévêque
Pessac, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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