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Studies

Observational Recruiting

NCT06465459 on ClinicalTrials.gov

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

Official title: ESCALLE : Post-marketing Clinical Study of the LambrE System for Left Auricle Closure

  • Sponsor: Société Française de Cardiologie
  • Collaborators: Lifetech Scientific (Shenzhen) Co., Ltd.
  • Enrollment: 220 (Estimated)
  • Study start: 2024-06-10 (Actual)
  • Primary completion: 2027-12-01 (Estimated)
  • Study completion: 2027-12-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

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

  • Atrial Fibrillation

Intervention / Treatment

  • Procedure: LAMBRE device implantation

Primary Outcome Measures

  • To assess the incidence of first cardiovascular event in patients implanted with a left atrial closure device. (during procedure and a follow-up lasting 12 months in a population having had a installation of an Lambre device)
    the occurrence of one of the following events: ischaemic stroke, systemic embolism, rate of device migration and death of cardiovascular or unexplained origin occurring in patients implanted with a left atrial closure device.

Countries

France

Locations and Investigators

  • Hôpital Cardiologique de Haut Lévêque, Pessac, France (Recruiting)
    • Xavier IRIART

Study Officials

  • Xavier IRIART (Principal Investigator) — Hôpital Cardiologique de Haut Lévêque