NCT03564951已完成不适用
Comparison of Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones in Addition to Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation
Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年2月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- Atrial fibrillation relapse between groups
研究概览
简要总结
Using isochronous maps during radiofrequency ablation procedures may identify the driver zones responsible for atrial fibrillation maintenance with greater accuracy compared to a conventional procedure (simple antral isolation of the associated pulmonary veins or, if necessary, combined with removal of spatio-temporal dispersal zones) that do not use isochronous maps, and thus improve the efficiency and safety of atrial fibrillation treatment by radiofrequency treatment.
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
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •The patient is at least 18 years old
- •The patient has paroxysmal or persistent atrial fibrillation
- •The patient is available for 18 month follow-up
排除标准
- •The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •The patient is pregnant or breastfeeding
- •Sinus rhythm has not been able to be determined using external electric cardioversion
- •Patient not susceptible to atrial fibrillation following wide antrum circle ablation
- •The subject has already been included in the study (patients cannot be included more than once)
结局指标
主要结局
Atrial fibrillation relapse between groups
时间窗: Month 18
Atrial fibrillation detected by routine or event-associated Holter examination
次要结局
- Atrial fibrillation relapse between groups(Month 12)
- Concordance of isochrone and voltage maps(Day 0)
- Comparison of the decreasing velocities between healthy zones and anisochronic zones in the same anatomic region(Day 0)
- Size of treated zones between groups(Day 0)
- Arrhythmia occurrence between groups(Month 18)
- Maximum variation of conduction speed between variation healthy zones with anisochronic zones in the same anatomic region(Day 0)
- Comparison of wave front rotation between healthy zones and anisochronic zones in the same anatomic region(Day 0)
- Number of treated zones between groups(Day 0)
- Survival without relapse of the subgroups paroxysmal versus persistent atrial fibrillation.(Month 18)
- Total time of radiofrequency between groups(Day 0)
- Total procedure time between groups(Day 0)
- List locations most frequently treated(Day 0)
- Comparison of lesion volume between groups(Day 0)
- Survival without relapse of the subgroups treated using the Carto- vs Rhythmia-guided ablation approaches.(Month 18)
研究者
研究点 (4)
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