Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LAMBRE device implantation.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ESCALLE : Post-marketing Clinical Study of the LambrE System for Left Auricle Closure
Overview
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.
Detailed description
This is a non-interventional, prospective and retrospective national multicentre study.
Interventions
- Procedure LAMBRE device implantation
LAMBRE device implantation
Primary outcome measures
- To assess the incidence of first cardiovascular event 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 device]
Secondary outcome measures (12)
- To evaluate the effectiveness of the device [Time frame: end of procedure]
- To evaluate the effectiveness of the device [Time frame: at 3 months after implantation]
- To evaluate the effectiveness of the device [Time frame: at 3 months after implantation]
- To evaluate the effectiveness of the device [Time frame: at 3 months after implantation]
- To evaluate the effectiveness of the device [Time frame: at 3 months after implantation]
- To evaluate the effectiveness of the device [Time frame: at 1 year after implantation]
- To evaluate the effectiveness of the device [Time frame: at 1 year after implantation]
- To evaluate the effectiveness of the device [Time frame: at 1 year after implantation]
- To evaluate the effectiveness of the device [Time frame: at 1 year after implantation]
- To evaluate the effectiveness of the device [Time frame: at 1 year after implantation]
- To evaluate the effectiveness of the device [Time frame: at 1 year after implantation]
- To evaluate the tolerance of the procedure and the device [Time frame: at the pre-discharge examination (up to 3 days)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Cardiologique de Haut Lévêque — Pessac
Identifiers
NCT: NCT06465459 · 2024-A00420-47