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临床试验/NCT04509180
NCT04509180撤回不适用

Comparison of Treatment Outcomes Between Convergent Procedure and Catheter Ablation for Persistent and Longstanding Persistent Atrial Fibrillation

University Medical Centre Ljubljana2 个研究点 分布在 1 个国家开始时间: 2021年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Noninferiority of catheter ablation

研究概览

简要总结

In the last 20 years, atrial fibrillation has become one of the leading healthcare burden in Europe and other developed countries. With an ever-increasing prevalence and incidence, atrial fibrillation is expected to remain a significant problem in the near future. Due to numerous detrimental effects atrial fibrillation has on the patient's health, having an efficient and safe treatment is crucial for managing the problem.

The gold standard for an atrial fibrillation treatment is a catheter ablation. In typical catheter ablation procedure, triggers in pulmonary veins are addressed with a pulmonary vein isolation- offering a high long-term success rate in patients with paroxysmal atrial fibrillation. However, the same cannot be said for persistent and longstanding persistent atrial fibrillation. Studies have shown that efficiency of catheter ablation for persistent and longstanding persistent atrial fibrillation, including multiple procedures per patient, ranges around 50 %. It is postulated that extrapulmonary vein triggers, such as foci located in the posterior wall of the left atrium, play an important role in initiating and maintaining persistent and longstanding persistent atrial fibrillation. In the past, to address this issue, a convergent procedure was developed. In convergent procedure an epicardial ablation of posterior wall is performed through a subxyphoid window. Next, an endocardial ablation with an ablation catheter is performed to isolate pulmonary veins. Because the epicardial lesions are applied in the opposite direction and not towards the esophagus, ablation of posterior wall can safely be performed. The procedure offers a high long-term success rate (85%) in patients with persistent and longstanding persistent atrial fibrillation. However, due to higher associated invasiveness, the convergent procedure carries a higher risk of complications compared with catheter ablation (4 % vs 9 %).

With advancements in ablation catheter technology, such as continuous force measurement at the tip of the catheter, the depth and volume of the lesion can be estimated. This information greatly increases the reliability of lesion formation. The operator can thus effectively apply lesions to the posterior wall of the left atrium more safely in regards to the collateral damage to the esophagus.

The objectives of the study are:

  • To compare procedural, safety and efficiency profile of convergent procedure with catheter ablation procedure, both targeting pulmonary veins triggers and triggers located in the posterior wall of the left atrium.
  • To compare long-term success rate of convergent procedure with catheter ablation procedure, both targeting pulmonary veins triggers and triggers located in the posterior wall of the left atrium.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed persistent and/or long-term
  • Failed medical therapy with antiarrhythmic drug therapy

排除标准

  • Expected life expectancy of less than one year
  • Previous heart operation
  • Previous ablation procedure
  • Left ventricular ejection fraction below 30 %
  • Severe valvular heart disease
  • Acute coronary syndrome
  • Diminished functional capacity due to non-cardiac co-morbidities
  • Pregnancy

结局指标

主要结局

Noninferiority of catheter ablation

时间窗: 1 year

arrhythmia-free survival registered with an implantable loop recorder

次要结局

  • Differences in AF burden(1 year)
  • Differences in acute success rate of posterior wall isolation(1 month)
  • Differences in complication rate(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matevz Jan

MD

University Medical Centre Ljubljana

研究点 (2)

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