NCT05065112尚未招募不适用
Individualised MApping-Guided Ablation to Improve Outcomes in pErsistent Atrial Fibrillation
适应症
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.
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)
研究者
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Unknown
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终止
不适用
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