Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure
ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFrench Cardiology Society
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Minor patient
Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or safeguard of justice)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
LAMBRE device implantation
Procedure/SurgeryLAMBRE device implantation
Treatment groups
220 Participants
are divided into 1 treatment groupGroup A: Patients scheduled for percutaneous left atrial closure with Lambre device implantation.1 intervention
Trial outcomes
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.
Time frame
during procedure and a follow-up lasting 12 months in a population having had a installation of an Lambre deviceSecondary outcomes
1
To evaluate the effectiveness of the device
The success rate of the procedure at the end of implantation
Time frame
end of procedure2
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
Time frame
at 3 months after implantation3
To evaluate the effectiveness of the device
the positioning of the prosthesis
Time frame
at 3 months after implantation4
To evaluate the effectiveness of the device
the rate of periprosthetic shunts on the atrial side of the prosthesis
Time frame
at 3 months after implantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
French Cardiology Society
Lead sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
Collaborator
Source ClinicalTrials.gov