Clinical trial NCT06465459: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: non-valvular atrial fibrillation
atrial fibrillation
LAMBRE system
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: Lifetech Scientific (Shenzhen) Co., Ltd.
First posted: 2024-06-18
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be included in cardiology departments participating in the study. Non-valvular atrial fibrillation patients at high cardio-embolic risk, contraindicated to anticoagulants, scheduled for percutaneous left atrial closure with implantation of the Lambre device will be included in the protocol and monitored as part of their care by the centers that performed the procedure.

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.


Eligibility 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)

Primary outcomes:
measure: To assess the incidence of first cardiovascular event in patients implanted with a left atrial closure device.
timeFrame: during procedure and a follow-up lasting 12 months in a population having had a installation of an Lambre device
Secondary outcomes:
measure: To evaluate the effectiveness of the device
timeFrame: end of procedure
measure: To evaluate the effectiveness of the device
timeFrame: at 3 months after implantation
measure: To evaluate the effectiveness of the device
timeFrame: at 3 months after implantation
measure: To evaluate the effectiveness of the device
timeFrame: at 3 months after implantation
measure: To evaluate the effectiveness of the device
timeFrame: at 3 months after implantation
measure: To evaluate the effectiveness of the device
timeFrame: at 1 year after implantation
measure: To evaluate the effectiveness of the device
timeFrame: at 1 year after implantation
measure: To evaluate the effectiveness of the device
timeFrame: at 1 year after implantation
measure: To evaluate the effectiveness of the device
timeFrame: at 1 year after implantation
measure: To evaluate the effectiveness of the device
timeFrame: at 1 year after implantation
measure: To evaluate the effectiveness of the device
timeFrame: at 1 year after implantation
measure: To evaluate the tolerance of the procedure and the device
timeFrame: at the pre-discharge examination (up to 3 days)
measure: To evaluate the tolerance of the procedure and the device
timeFrame: at 3 months
measure: To evaluate the tolerance of the procedure and the device
timeFrame: at 1 year
measure: Description of bleeding complications not related to the device or procedure
timeFrame: during procedure and a follow-up lasting 12 months in a population having had a inmplantation of an Lambre device
measure: Description of the population and centers
timeFrame: at baseline
measure: Description of antithrombotic treatments prescribed following implantation of the device
timeFrame: at inclusion, at the pre-discharge examination (up to 3 days), at 30 days, 3 months and 12 months after implantation
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hôpital Cardiologique de Haut Lévêque
Study officials:
affiliation: Hôpital Cardiologique de Haut Lévêque
name: Xavier IRIART
role: PRINCIPAL_INVESTIGATOR
References: