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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-10

Study Completion Date

2027-06-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events

NCT04559243

Non-valvular Atrial Fibrillation Embolic Stroke

RECRUITING

Assessing the Safety and Efficacy of the LAmbre™ Plus Device

NCT06465706

Atrial Fibrillation

NOT_YET_RECRUITING NA

Safety and Efficacy Study of LAmbre LAA Closure Device for Treating AF Patients Who Cannot Take Warfarin

NCT02029014

Atrial Fibrillation

UNKNOWN PHASE3

Clinical Investigation of the LAmbre Left Atrial Appendage Closure System

NCT03122028

Atrial Fibrillation

COMPLETED NA

Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF

NCT04684212

Atrial Fibrillation Left Atrial Appendage Thrombosis CVA

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

LAMBRE device implantation

Intervention Type PROCEDURE

LAMBRE device implantation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LAMBRE device implantation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No