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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: LAMBRE device implantation

Detailed Description

This is a non-interventional, prospective and retrospective national multicentre study.

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

• Study Contact: Name: Dr Xavier IRIART; Phone Number: (+33) 1 44 90 70 29; Email: escalle@sfcardio.fr

Study Locations

• France
  • Pessac, France, 33600
    • Recruiting
    • Hôpital Cardiologique de Haut Lévêque
    • Contact: Xavier IRIART; Phone Number: (+33)1 44 90 70 29; Email: escalle@sfcardio.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients scheduled for percutaneous left atrial closure with Lambre device implantation.	Procedure: LAMBRE device implantation; LAMBRE device implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: French Cardiology Society
• Collaborators: Lifetech Scientific (Shenzhen) Co., Ltd.
• Investigators: Principal Investigator: Xavier IRIART, Hôpital Cardiologique de Haut Lévêque

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: atrial fibrillation; non-valvular atrial fibrillation; LAMBRE system
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: 2024-A00420-47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No