NCT03564327已完成不适用
Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation and Interest of the Isochron Map
Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 175 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
- 175
- 试验地点
- 4
- 主要终点
- Atrial fibrillation relapse in non-reducible or non-inducible patients
研究概览
简要总结
Identify the parameters of the predictive isochronous map for the clinical outcome of radiofrequency ablation in terms of absence of documented atrial fibrillation recurrence at 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 is available for 18 month follow-up
- •The patient has paroxysmal or persistent atrial fibrillation
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 Early Study Exit Criteria: Patient does not have paroxysmal or persistent AF at the time of inclusion
结局指标
主要结局
Atrial fibrillation relapse in non-reducible or non-inducible patients
时间窗: Month 18
Atrial fibrillation detected by routine or event-associated Holter examination
次要结局
- Wave front rotation in the same anatomic region in non-inducible patients(Day 0)
- Total time of radiofrequency in non-inducible patients(Day 0)
- Total procedure time in non-inducible patients(Day 0)
- Comparison of lesion volume in non-inducible patients(Day 0)
- Number and size of treated zones by guided versus conventional ablation in non-inducible patients(Day 0)
- List locations most frequently treated(Day 0)
- Survival without relapse of patients treated using the Carto- vs Rhythmia-guided ablation approaches in non-reducible or non-inducible patients(Month 18)
- Atrial fibrillation relapse in non-reducible or non-inducible patients(Month 12)
- Arrhythmia occurrence in non-reducible or non-inducible patients(Month 18)
- Identification of zones of low voltage on voltage maps in non-inducible patients(Day 0)
- Identification of zones of anisochronic zones on voltage maps in non-inducible patients(Day 0)
- Maximum variation of conduction speed in the same anatomic region in non-inducible patients(Day 0)
- Decreasing velocities in the same anatomic region in non-inducible patients(Day 0)
- Atrial fibrillation relapse in non-reducible or non-inducible patients(Month 12)
- Arrhythmia occurrence in non-reducible or non-inducible patients(Month 18)
- Identification of zones of low voltage on voltage maps in non-inducible patients(Day 0)
- Identification of zones of anisochronic zones on voltage maps in non-inducible patients(Day 0)
- Maximum variation of conduction speed in the same anatomic region in non-inducible patients(Day 0)
- Decreasing velocities in the same anatomic region in non-inducible patients(Day 0)
- Wave front rotation in the same anatomic region in non-inducible patients(Day 0)
- Total time of radiofrequency in non-inducible patients(Day 0)
- Total procedure time in non-inducible patients(Day 0)
- Comparison of lesion volume in non-inducible patients(Day 0)
- Number and size of treated zones by guided versus conventional ablation in non-inducible patients(Day 0)
- List locations most frequently treated(Day 0)
- Survival without relapse of patients treated using the Carto- vs Rhythmia-guided ablation approaches in non-reducible or non-inducible patients(Month 18)
研究者
研究点 (4)
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