ESCALLE : Post-marketing Clinical Study of the LambrE System for Left Auricle Closure
概览
- 阶段
- 不适用
- 干预措施
- LAMBRE device implantation
- 疾病 / 适应症
- Atrial Fibrillation
- 发起方
- French Cardiology Society
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- To assess the incidence of first cardiovascular event in patients implanted with a left atrial closure device.
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
This is a non-interventional, prospective and retrospective national multicentre study.
研究者
入排标准
入选标准
- •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
排除标准
- •Minor patient
- •Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or safeguard of justice)
研究组 & 干预措施
Patients scheduled for percutaneous left atrial closure with Lambre device implantation.
干预措施: LAMBRE device implantation
结局指标
主要结局
To assess the incidence of first cardiovascular event in patients implanted with a left atrial closure device.
时间窗: 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.
次要结局
- 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)
- Description of the population and centers(at baseline)
- To evaluate the tolerance of the procedure and the device(at 1 year)
- 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)
- To evaluate the effectiveness of the device(end of procedure)
- To evaluate the effectiveness of the device(at 1 year after implantation)
- To evaluate the effectiveness of the device(at 3 months after implantation)
- To evaluate the tolerance of the procedure and the device(at the pre-discharge examination (up to 3 days))
- To evaluate the tolerance of the procedure and the device(at 3 months)