Real-World Safety and Effectiveness of Catheter Ablation of Paroxysmal Atrial Fibrillation as Initial Rhythm Control Therapy With the THERMOCOOL SMARTTOUCH SF Catheter - A Sub-study of REAL AF Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 344
- 试验地点
- 12
- 主要终点
- Primary safety
研究概览
简要总结
To generate real-world evidence from the parent study, REAL AF registry, on the use of Thermocool SmartTouch SF (STSF) catheter in ablation for the treatment of paroxysmal atrial fibrillation (PAF).
详细描述
The primary objective of this registry is to evaluate effectiveness and safety of Thermocool STSF catheter to support an indication extension of the STSF catheter using real world data from the REAL AF registry. Subjects included in the registry will be those in which the STSF catheter is used for the treatment of symptomatic PAF in antiarrhythmic drug (AAD) naive patients as an initial rhythm control therapy. The registry will involve retrospective analysis of data prospectively collected from the REAL AF registry. The registry will include consecutive, eligible patients from the REAL AF registry, starting from October 2021 who meet the sub-study eligibility criteria until 344 eligible subjects are identified. Eligible patients from all participating centers in the REAL AF registry will be included, except for sites with standard-of-care rhythm monitoring less than 48 hours and those that do not perform 6-12 month follow up as standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Diagnosed with symptomatic PAF
- •First time ablation
- •Ablation performed with the Thermocool STSF catheter
- •Age 18 or over at the time of the index ablation procedure
排除标准
- •Received Class I or III antiarrhythmic drug prior to the index ablation.
- •Did not previously consent for their anonymized data to be used for research purposes.
- •Rhythm monitoring less than 48 hours.
结局指标
主要结局
Primary safety
时间窗: 30 days
Cardiac tamponade/pericardial effusion post index ablation
Primary effectiveness
时间窗: Post 3-month blanking period
Any repeat ablation procedure, use of class I/III AAD, or cardioversion post-blanking for treatment of atrial arrhythmia will be deemed failure of primary effectiveness endpoint.
次要结局
未报告次要终点
