Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure
NCT Number: NCT06465459
Acronym: ESCALLE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation
Interventions: PROCEDURE: LAMBRE device implantation
Sponsor: French Cardiology Society
Collaborators: Lifetech Scientific (Shenzhen) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-10
Completion Date: 2027-06-10
Locations: Hôpital Cardiologique de Haut Lévêque, Pessac, 33600, France

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.

Primary Outcome Measures: To assess the incidence of first cardiovascular event in patients implanted with a left atrial closure 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., during procedure and a follow-up lasting 12 months in a population having had a installation of an Lambre device
Secondary Outcome Measures: To evaluate the effectiveness of the device, The success rate of the procedure at the end of implantation, end of procedure|To evaluate the effectiveness of the device, the results of the scanner and/or transesophageal ultrasound concerning the rate of occlusion of the left auricle, at 3 months after implantation|To evaluate the effectiveness of the device, the positioning of the prosthesis, at 3 months after implantation|To evaluate the effectiveness of the device, the rate of periprosthetic shunts on the atrial side of the prosthesis, at 3 months after implantation|To evaluate the effectiveness of the device, the rate of periprosthetic thrombus on the atrial side of the prosthesis, at 3 months after implantation|To evaluate the effectiveness of the device, The rate of ischemic stroke, at 1 year after implantation|To evaluate the effectiveness of the device, The rate of TIA, at 1 year after implantation|To evaluate the effectiveness of the device, The rate of systemic embolism, at 1 year after implantation|To evaluate the effectiveness of the device, The rate of death of cardiovascular or unexplained origin, at 1 year after implantation|To evaluate the effectiveness of the device, The rate of death, at 1 year after implantation|To evaluate the effectiveness of the device, The comparison of the frequency of ischemic cerebral or systemic accidents to the theoretical predicted value, at 1 year after implantation|To evaluate the tolerance of the procedure and the device, Complications linked or potentially linked to the implantation procedure or the device, percentage of device migration or pericardial effusion by trans-thoracic or trans-esophageal ultrasound, at the pre-discharge examination (up to 3 days)|To evaluate the tolerance of the procedure and the device, percentage of thrombosis on prosthesis or migration of the prosthesis by scanner and/or in the absence of trans-esophageal ultrasound, at 3 months|To evaluate the tolerance of the procedure and the device, Percentage of major and/or life-threatening bleeding complications and total percentage of complications related or potentially related to the procedure or device, at 1 year|Description of bleeding complications not related to the device or procedure, Percentage of patients who experienced at least one bleeding complication unrelated to the device or procedure during the entire study, during procedure and a follow-up lasting 12 months in a population having had a inmplantation of an Lambre device|Description of the population and centers, demographic and clinical characteristics of patients, at baseline|Description of antithrombotic treatments prescribed following implantation of the device, Percentage of patients on injectable or oral anticoagulants and on antiplatelet agents at the different follow-up times, Percentage of patients on injectable or oral anticoagulants at different follow-up times, Percentage of patients on antiplatelet agents in mono or dual therapy at the different follow-up times, Average duration of anticoagulant and antiplatelet treatments., at inclusion, at the pre-discharge examination (up to 3 days), at 30 days, 3 months and 12 months after implantation