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临床试验/NCT06124690
NCT06124690进行中(未招募)不适用

Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas: a Prospective Randomized Trial

Robert Bosch Medical Center2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年9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
150
试验地点
2
主要终点
Number of participants with atrial arrhythmia recurrence after 12 months follow-up

研究概览

简要总结

An effective therapy of persistent atrial fibrillation beyond pulmonary vein isolation remains unsatisfactory. Targeting endocardial low-voltage areas represents an approach of substrate modification.

This prospective, randomized study investigated the efficacy of ablation of low-voltage areas versus PVI and additional linear ablations in patients with persistent atrial fibrillation in terms of single-procedure arrhythmia-free outcome and safety.

详细描述

Pulmonary vein isolation has become the cornerstone of the interventional treatment of paroxysmal atrial fibrillation. For the treatment of persistent atrial fibrillation the data remains unclear. All different approaches remain unsatisfactory for the treatment of persistent atrial fibrillation, including single pulmonary vein isolation, targeting endocardial areas of low-voltage, identifying areas with complex fractionated atrial electrograms (CFAE), ablating linear lines such as an anterior line, a roof-line or mitral isthmus line. Recurrence rates are still higher as compared to paroxysmal atrial fibrillation ablation. Several studies showed a good correlation between the volume of low-voltage areas (LVA) and the burden of atrial fibrillation. Earlier studies that investigated ablation therapy using a substrate-guided ablation as compared to circumferential pulmonary vein isolation (CPVI) alone, mostly showed no significant difference in recurrence rates between both approaches. In contrast, some other studies showed better outcomes when targeting low-voltage areas. However, there was significant heterogeneity in patient selection, mapping and ablation strategies and therefore, comparisons are hard to make.

The patients are randomized into three different treatment arms (Group 1: PVI alone if no low voltage areas are detected, Group 2: PVI alone if low voltage areas are detected, Group 3: PVI plus ablation of low voltage areas.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persistent atrial fibrillation according to the current guidelines
  • Age > 18 years
  • Patient information

排除标准

  • 未提供

结局指标

主要结局

Number of participants with atrial arrhythmia recurrence after 12 months follow-up

时间窗: 12 months

Number of participants with atrial arrhythmia recurrence after 12 months follow-up

次要结局

  • Number of procedural complications(12 months)

研究者

发起方
Robert Bosch Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cathrin Theis

Principal Invetsigator, Head of Electrophysiology

Robert Bosch Medical Center

研究点 (2)

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