Individualised MApping-Guided Ablation to Improve Outcomes in pErsistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 212
- 主要终点
- Freedom from atrial arrhythmia
研究概览
简要总结
A clinical randomised trial to compare strategies for ablation in persistent and long-standing persistent atrial fibrillation comprising of two arms: pulmonary veins isolation (PVI) only and PVI + individualised mapping-guided ablation (Cartofinder, Biosense Webster Inc.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Signed informed consent.
- •Scheduled to undergo a clinically indicated, first-time catheter ablation procedure for the treatment of persistent atrial fibrillation.
- •In atrial fibrillation at the time of the index procedure.
排除标准
- •Paroxysmal atrial fibrillation.
- •Previous ablation procedure for atrial fibrillation.
- •Left ventricular ejection fraction < 45%
- •Obesity with BMI > 35 kg/m2
- •Congenital heart disease.
- •Previous cardiac surgery with atriotomy.
- •Previous left atrial appendage closure/ligation.
- •Contraindications to systemic anticoagulation, catheter ablation, and/or general anaesthesia.
- •Current enrolment in a study evaluating another device or drug.
研究组 & 干预措施
PVI only
Patients in this arm will undergo only standard pulmonary veins isolation with radiofrequency (RF) energy to treat their AF.
干预措施: Pulmonary veins isolation (Procedure)
PVI + IM
Patients in this arm will undergo standard wide area circumferential pulmonary veins isolation along with radiofrequency energy and additional RF ablation guided by individualised mapping with Cartofinder to treat their AF.
干预措施: Pulmonary veins isolation + Cartofinder-guided ablation (Procedure)
结局指标
主要结局
Freedom from atrial arrhythmia
时间窗: 12 monts
Freedom from any atrial arrhythmia without the use of antiarrhythmic drugs
次要结局
- Freedom from atrial fibrillation(12 months)
- Atrial fibrillation burden reduction(12 months)
- Absolute atrial fibrillation burden(12 months)