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

NCT06465459 | Recruiting

• 1 other identifier: 2024-A00420-47
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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

Keywords

non-valvular atrial fibrillation; atrial fibrillation; LAMBRE system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• To evaluate the effectiveness of the device

  end of procedure

• To evaluate the effectiveness of the device

  at 3 months after implantation

• To evaluate the effectiveness of the device

  at 3 months after implantation

• To evaluate the effectiveness of the device

  at 3 months after implantation

• To evaluate the effectiveness of the device

  at 3 months after implantation

Study Arms (1)

Patients scheduled for percutaneous left atrial closure with Lambre device implantation.

Procedure: LAMBRE device implantation

Interventions

LAMBRE device implantation PROCEDURE

LAMBRE device implantation

Patients scheduled for percutaneous left atrial closure with Lambre device implantation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18 years
• Patient has been informed of the nature of the study and agrees to participate

You may not qualify if:

• Minor patient
• Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or safeguard of justice)

Sponsors & Collaborators

• French Cardiology Society: lead
• Lifetech Scientific (Shenzhen) Co., Ltd.: collaborator

Study Sites (1)

Hôpital Cardiologique de Haut Lévêque

Pessac, 33600, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xavier IRIART

  Hôpital Cardiologique de Haut Lévêque

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Xavier IRIART

CONTACT

(+33) 1 44 90 70 29; escalle@sfcardio.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 18, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

FR (1)