National Registry of Cardioneuroablation in Recurrent Reflex Syncope
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 14
- 主要终点
- Recurrence of vasovagal syncope
研究概览
简要总结
This registry aims to collect patient data on cardioneuroablation for vasovagal syncope from multiple centers in France. The aim is to evaluate success rates, compare techniques and help institutions set up their own cardioneuroablation program
详细描述
Cardioneuroablation is an emerging technique used to treat patients with vagally-mediated extrinsic bradycardia. It seems particularly efficient in patients with recurrent vasovagal syncope due to a strong cardioinhibitory effect. The procedure consists in using radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias. Key questions concerning this procedure still remain unanswered: 1) What is the success rate of the procedure 2) Which patients will benefit from this technique? 3) Which fat pads should be targeted during the procedure? 4) What is the best way of identifying the location of these fat pads? 5) What are the long-term effects of this procedure? A multicenter registry seems ideal to try to answer these questions at minimal cost
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 or more
- •Recurrent vasovagal syncope (≥2 episodes during the last year) with an asystolic component (≥3 second pause) recorded during a spontaneous episode. The asystole can be related to sinus arrest or paroxysmal AV block.
- •Scheduled cardioneuroablation procedure
- •Estimated residual battery life ≥ 1 year.
- •Patient affiliated to or beneficiary of national health security scheme.
- •Patient who have received an information notice and has not objected to the use of their data in the registry.
排除标准
- •Contraindication to anticoagulation therapy: major bleeding, risk of major bleeding, severe hepatic disease
- •Contraindication to cardiac CT: contrast medium allergies
- •Intracardiac thrombus
- •Patient detained by judicial or administrative decision.
结局指标
主要结局
Recurrence of vasovagal syncope
时间窗: 12 months
Number of patients with recurrence
次要结局
- Recurrence of vasovagal syncope in different subgroups(12 months)
- Efficacy of cardioneuroablation procedure(12 months)
- prevalence of post-ablation pre-syncopal events(12 months)
- correlation between ablation sites and epicardial fat pads(12 months)
- Quality of life of post-ablated patients (Score 1)(12 months)
- Quality of life of post-ablated patients (Score 2)(12 months)
- Assessment of technical learning curve by centre(12 months)