NCT04945746进行中（未招募）不适用
Study Evaluating the Prioritization of Ablation Zones According to the Stability of the Dispersion
Hospital St. Joseph, Marseille, France2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年8月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- AF termination rate after ablation of the most stable regions (levels 3 and 2)
研究概览
简要总结
To assess the acute efficacy of ablation of the most stable VX1 areas (levels 2 and 3) in terms of the rate of acute AF termination.
Identify the spatial distribution of dispersion stability levels based on VX1. Document the rate of adverse events. To assess the long-term efficacy of ablation of the most stable VX1 areas in terms of the absence of documented arrhythmias during a 12-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients 18 years of age or older candidates with Persistent or long-standing persistent AF with documentation of (ECG, Holter, physician's letter):
- •AF duration of ≥ 3 months and ≤ 5 years or
- •1 effective cardioversion followed by AF recurrence lasting ≥ 3 months
- •Continuous anticoagulation with warfarin (INR 2-3) or NOAC for > 4 weeks prior to ablation
- •Patients must be able and willing to provide written informed consent to participate in the clinical trial
- •Maximum of 50% of patients (13 patients) in persistent AF < 12 months (>30% of long-standing persistent AF ≥ 12 months)
- •Being affiliated to a social security scheme or beneficiary of such a scheme
排除标准
- •Paroxysmal and short-standing persistent AF < 3 months
- •Severe obesity (BMI > 45)
- •LA thrombus on Transesophageal Echocardiography (TEE) prior to procedure
- •Contraindications to anticoagulation (heparin, warfarin or NOAC)
- •Patients who are or may potentially be pregnant
- •Any cardiac surgery within the past 2 months (60 days) (includes PCI)
- •Myocardial infarction within the past 2 months (60 days)
- •History of blood clotting or bleeding abnormalities
- •Documented thromboembolic event (including TIA) within the past 12 months (365 days)
- •Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
- •Unstable angina within the past month
- •Acute illness or active systemic infection or sepsis (including COVID 19)
- •Enrollment in an investigational study evaluating another device, biologic, or drug
- •Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
- •Life expectancy or other disease processes likely to limit survival to less than 12 monthsLife expectancy or other disease processes likely to limit survival to less than 12 months
- •Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)
- •Patient protected (guardianship or curatorship), or deprived of liberty by a judicial or administrative decision;
- •Person subject to a safeguard measure.
结局指标
主要结局
AF termination rate after ablation of the most stable regions (levels 3 and 2)
时间窗: at the end of the procedure
sinus rhythm at the end of the procedure
次要结局
未报告次要终点
研究者
研究点 (2)
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