跳至主要内容
临床试验/NCT05883722
NCT05883722尚未招募不适用

Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation With Right Atrial Enlargement

Xu Liu0 个研究点目标入组 200 人开始时间: 2023年6月30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
200
主要终点
Atrial fibrillation recurrence

研究概览

简要总结

Persistent atrial fibrillation (PerAF) can induce right atrial (RA) enlargement. Our previous study demonstrated patients with PerAF and RA enlargment may benefit from adjunctive RA ablation. Therefore, we conduct this multicenter, prospective, randomized study to confirm the value of adjunctive RA ablation.

详细描述

Long-term persistent atrial fibrillation (PerAF) may induce right atrial (RA) enlargement and subsequently atrial functional tricuspid regurgitation (AF-TR) at the absence of structural valvular lesion, abnormal right ventricular geometry and function. Enlarged RA and significant AF-TR may aggravate atrial remodeling and contribute to AF sustaining. Previous studies showed that RA enlargement was closely related to the recurrence of AF after catheter ablation. However, unlike the left atrium, the RA mechanism has been poorly studied and generally excluded from the therapeutic target. In an animal model of right heart disease, the RA enlargement associated with re-entrant activity serves as the prominent mechanism of AF genesis. Using sophisticated mapping techniques, recent study has confirmed that up to one-third of AF drivers are located in the right atrium. Furthermore, our previous case report also showed that the majority of patients with right atrial appendage-driven AF have concomitant RA enlargement. Therefore, it is plausible to hypothesize that the presence of RA enlargement represents the necessity of adjunctive RA ablation. Currently, the value and timing of RA intervention are still under debate. Therefore, the purpose of the present study was to testify whether patients with PerAF and RA enlargement may benefit from adjunctive RA ablation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed as persistent atrial fibrillation according to the latest clinical guidelines;
  • Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment.

排除标准

  • Uncontrolled congestive heart failure;
  • History of severe valve disease and/or prosthetic valve replacement;
  • Myocardial infarction or stroke within 6 months;
  • Severe congenital heart disease;
  • EF <40%;
  • Contrast agent allergy;
  • The use of anticoagulant drugs is contraindicated;
  • Severe lung disease;
  • Left atrial thrombus confirmed by preoperative esophageal ultrasound;
  • Contraindications for cardiac catheterization;
  • Atrial fibrillation ablation;
  • Have performed any cardiac surgery within 2 months;
  • Poor general health;
  • Life expectancy < 6 months.

结局指标

主要结局

Atrial fibrillation recurrence

时间窗: 12 months

any AF episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs at 12 months after a single procedure.

次要结局

  • Atrial fibrillation/atrial tachycardia recurrence(12 months)

研究者

发起方
Xu Liu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xu Liu

Prof

Shanghai Chest Hospital

相似试验