NCT03026413已完成不适用
The Comparison Between the Pulmonary Vein Antrum Modification by SmartTouch Ablation Catheter With Contact Force Monitoring and Circumferential Pulmonary Vein Isolation by That Without Contact Force Monitoring Plus Lasso Catheter for the Patients of Paroxysmal Atrial Fibrillation: a Randomized Controlled Trial
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
- 180
- 主要终点
- any recorded atrial arrhythmias proved by 7-day holter
研究概览
简要总结
To compare the efficacy and safety of circumferential pulmonary vein isolation without contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial fibrillation.
详细描述
This is a single centre, prospective control study. The study will enroll 180 patients with 2:1 grouped.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with paroxysmal atrial fibrillation refractory to drugs
- •with consent
排除标准
- •LVEF<50%
- •history of cardiac surgery
- •valvular heart disease
- •abnormal thyroid function
- •left atrial thrombus
研究组 & 干预措施
PVAM
Experimental
pulomonary vein antrum modification with contact force monitoring for AF
干预措施: pulmonary vein antrum modification (Procedure)
Control arm
Active Comparator
pulmonary vein isolation without contact force
干预措施: pulmonary vein antrum modification (Procedure)
结局指标
主要结局
any recorded atrial arrhythmias proved by 7-day holter
时间窗: at least 18 months follow up
sustained at least 30s
次要结局
- procedure time(time during patient enrollment)
- x ray time(time during patient enrollment)
- adverse event(at least 18 months follow up)
研究者
Minglong Chen
Professor and Director of Cardiac EP Vice Director of Dept. of Cardiology
The First Affiliated Hospital with Nanjing Medical University
相似试验
Unknown
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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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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-ESAZ Sint-Jan Brugge-Oostende AV220
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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: 20.0 Level: LLT Classification code 10071667 Term: Persistent atrial fibrillation System Organ Class: 100000004849EUCTR2018-002103-33-FRAZ Sint-Jan Brugge-Oostende AV220
进行中（未招募）
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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: 20.0 Level: LLT Classification code 10071667 Term: Persistent atrial fibrillation System Organ Class: 100000004849EUCTR2018-002103-33-ATAZ Sint-Jan Brugge-Oostende AV220