Atrial Fibrillation
Conditions
Keywords
non-valvular atrial fibrillation, atrial fibrillation, LAMBRE system
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.
Detailed description
This is a non-interventional, prospective and retrospective national multicentre study.
Interventions
PROCEDURELAMBRE device implantation
LAMBRE device implantation
Sponsors
French Cardiology Society
Lifetech Scientific (Shenzhen) Co., Ltd.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the incidence of first cardiovascular event 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effectiveness of the device | end of procedure | The success rate of the procedure at the end of implantation |
| To evaluate the tolerance of the procedure and the device | at the pre-discharge examination (up to 3 days) | 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 |
| Description of bleeding complications not related to the device or procedure | during procedure and a follow-up lasting 12 months in a population having had a inmplantation of an Lambre device | Percentage of patients who experienced at least one bleeding complication unrelated to the device or procedure during the entire study |
| Description of the population and centers | at baseline | demographic and clinical characteristics of patients |
| Description of antithrombotic treatments prescribed following implantation of the device | at inclusion, at the pre-discharge examination (up to 3 days), at 30 days, 3 months and 12 months after implantation | 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. |
Countries
France
Contacts
CONTACTDr Xavier IRIART
PRINCIPAL_INVESTIGATORXavier IRIART
Hôpital Cardiologique de Haut Lévêque
Outcome results
None listed