跳至主要内容
临床试验/NCT07092774
NCT07092774进行中(未招募)不适用

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

Heart Rhythm Clinical and Research Solutions, LLC12 个研究点 分布在 1 个国家目标入组 344 人开始时间: 2024年4月1日最近更新:

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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