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临床试验/NCT06183619
NCT06183619进行中(未招募)不适用

Superior Vena Cava Isolation Plus Pulmonary Vein Isolation for Paroxysmal Atrial: a Multi-center Retrospective Study

Chinese Academy of Medical Sciences, Fuwai Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年2月1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
400
试验地点
1
主要终点
AT/AF recurrence

研究概览

简要总结

Pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) has limited success. The superior vena cava (SVC) has been identified as one of the most common non-pulmonary vein triggers for PAF. It is estimated that SVC isolation (SVCI) could improve the clinical results of patients with PAF. However, results from previous studies about SVCI remain controversial. Safety concerns for SVCI may outweigh its benefits and lead to inadequate ablation. To address this issue, the introduction of a quantitative ablation index (AI) for SVCI may provide a solution. Therefore, the investigators sought to initiate a retrospective, multi-center study, to explore the efficacy and safety of quantitative SVCI in addition to PVI in PAF.

详细描述

Catheter ablation has emerged as an effective treatment for drug-refractory PAF and is recommended as first-line therapy by current guidelines. PVI is considered the cornerstone of catheter ablation for atrial fibrillation (AF). However, despite persistent PVI, a subgroup of patients may experience recurrent AF due to focal ectopic discharges originating outside the pulmonary veins. Among the non-pulmonary vein triggers, the SVC stands out as a common culprit, making it a promising ablation target for maintaining sinus rhythm. Nevertheless, results from previous studies that evaluated the efficacy of SVCI showed conflicting results. One possible explanation is that SVC is adjacent to critical anatomical structures (such as the sinus node and the phrenic nerve), which raises safety concerns and often leads to inadequate ablation.

Therefore, it is necessary to establish a standardized ablation procedure for SVCI, ensuring both safety and efficacy. To address this issue, the investigators proposed the concept of "quantitative ablation for SVCI." By introducing AI as a quantitative measure, it is possible to achieve precise catheter ablation while minimizing the risk of procedure-related complications.

This study aimed to investigate the safety and feasibility of quantitative AI-guided SVCI in addition to PVI. Participants with PAF who required catheter ablation will be consecutively enrolled in three hospitals in China.

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

入选标准

  • Symptomatic paroxysmal AF that are unresponsive to antiarrhythmic drugs (one or more than one).
  • Willing to undergo catheter ablation for AF.

排除标准

  • History of any type of catheter ablation for cardiac arrhythmias.
  • Sinus node dysfunction that requires permanent pacemaker implantation.

结局指标

主要结局

AT/AF recurrence

时间窗: 12 months

atrial fibrillation, atrial flutter, atrial tachycardia over 30s

次要结局

未报告次要终点

研究者

发起方
Chinese Academy of Medical Sciences, Fuwai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun Liu,MD

Attending doctor

Chinese Academy of Medical Sciences, Fuwai Hospital

研究点 (1)

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