NCT01260220已完成不适用
Randomized Trial of Segmental Versus Circumferential Antral Ablation in Paroxysmal Atrial Fibrillation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Freedom from atrial fibrillation
研究概览
简要总结
An isolation-limited segmental antral approach to pulmonary vein isolation is as effective in achieving long-term freedom from atrial fibrillation as the standard anatomic, circumferential antral ablation.
详细描述
This is a randomized controlled non-inferiority designed trial.
Follow up:
Patients will stop their anti-arrhythmic drugs 2 months post procedure. Follow-ups will involve clinical assessment, holter and/or loop recorders at 3, 6, 9, and 12 month intervals.
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
- •Paroxysmal Atrial Fibrillation (PAF) for at least 6 months with at least 1 symptomatic episode during the previous 6 moths
- •Patient must be felt to be candidates for Atrial Fibrillation (AF) ablation based on AF that is symptomatic and refractory or intolerant to at least one class 1 or 3 anti-arrhythmic agent
- •Documentation of at least one episode of AF on 12 lead ECG, TTM or Holter monitor within 12 months of randomization in the trial
- •Patient must be on continuous anti-coagulation with warfarin (INR 2-3) or fractionated subcutaneous heparin for >4 weeks prior to the ablation or they have undergone a recent (less than 48 hours before planned ablation) transoesphageal echocardiogram to exclude left atrial thrombus.
- •Patient must provide written informed consent to participate in the clinical trial
排除标准
- •Contraindications to oral anticoagulants
- •History of any previous ablation for AF
- •Intracardiac thrombus
- •AF due to reversible causes
- •Pregnancy
- •atriotomy scar (typically, MV or TV repair/replacement, ASD surgery, transplants)(CABG are okay)
研究组 & 干预措施
Circumferential
Active Comparator
Completing a complete circle of RF lesions around the left and right pulmonary veins
干预措施: Circumferential Antral Ablation (Procedure)
Segmental
Experimental
Isolating the left and right pulmonary veins through RF lesions with a segmental antral approach.
干预措施: Segmental Antral ablation (Procedure)
结局指标
主要结局
Freedom from atrial fibrillation
时间窗: six months
Symptomatic atrial fibrillation recurrence (without anti-arrhythmic med's)
次要结局
- Procedure time((4-6) hours From the time patient is draped to the time electrophysiology catheters are removed from the body (same day in the electrophysiology lab))
- Ablation Time((4-6 hours) Measured during the procedure.)
- Fluoroscopy Time((4-6 Hours) Measured during the procedure.)
- complications(6 months)
研究者
研究点 (2)
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Continuing versus stopping heart rhythm medication after an operation restoring your normal heart rhythm in patients with a heart rhythm disorder: a study across multiple hospitals.Symptomatic persistent atrial fibrillation: atrial fibrillation, that lasts longer than 7 days, including episodes that are terminated by cardioversion, either with drugs or by direct current cardioversion, after 7 days or more. Episodes of atrial fibrillation have to be accompanied by symptoms.MedDRA version: 20.0Level: LLTClassification code 10071667Term: Persistent atrial fibrillationSystem Organ Class: 100000004849EUCTR2018-002103-33-DKAZ Sint-Jan Brugge-Oostende AV220
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进行中（未招募）
1 期
Continuing versus stopping heart rhythm medication after an operation restoring your normal heart rhythm in patients with a heart rhythm disorder: a study across multiple hospitals.Symptomatic persistent atrial fibrillation: atrial fibrillation, that lasts longer than 7 days, including episodes that are terminated by cardioversion, either with drugs or by direct current cardioversion, after 7 days or more. Episodes of atrial fibrillation have to be accompanied by symptoms.MedDRA version: 20.0 Level: LLT Classification code 10071667 Term: Persistent atrial fibrillation System Organ Class: 100000004849EUCTR2018-002103-33-FRAZ Sint-Jan Brugge-Oostende AV220