NCT07159685尚未招募不适用
Sex-Based Differences of Left Atrium: Impact on Atrial Fibrillation Ablation.
Centro Medico Teknon1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2026年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Efficacy in AF freedom
研究概览
简要总结
The aim of the study is to assess sex-related differences in patients who underwent a first ablation procedure for paroxysmal or persistent AF, guided by the personalized ablation strategy of the BY-LAWT protocol. Specifically, to compare anatomical characteristics, procedural parameters, and clinical outcomes between sexes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 who underwent a first ablation procedure for atrial fibrillation (paroxysmal or persistent).
- •Availability of an adequate pre-procedural cardiac CT scan for LAWT, LAV and inFAT analysis.
- •Availability of complete procedural data, including ablation index (AI) values recorded using the SmartTouch catheter (Biosense Webster).
- •Availability of 12-month follow-up data for efficacy and safety endpoint evaluation.
- •Ablation performed according to the by-LAWT protocol
排除标准
- •Age < 18 years.
- •Previous cardiac ablation (including AF ablation or other arrhythmias).
- •Incomplete data regarding procedural parameters, or follow-up.
- •Poor quality pre-procedural cardiac MDCT
- •Ablation not performed according to the BY-LAWT protocol.
- •Structural heart disease (e.g., dilated cardiomyopathy, valvular heart disease with surgical indication) that could substantially influence atrial dimensions or ablation response.
结局指标
主要结局
Efficacy in AF freedom
时间窗: from the procedure to 12 months later
The primary efficacy endpoint will be freedom from any atrial arrhythmia (AF, atrial tachycardia \[AT\], or atrial flutter \[AFL\]) at the 12-month follow-up. The following definitions apply
次要结局
未报告次要终点
研究者
Antonio Berruezo, MD, PhD
Chief of Electrophysiology Unit
Centro Medico Teknon
研究点 (1)
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