跳至主要内容
临床试验/NCT07109141
NCT07109141招募中不适用

Registry of Atrial Arrhythmia Ablation Procedures Using Pulsed Field Ablation in Poland

Wroclaw Medical University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Recurrence of supraventricular arrhythmia

研究概览

简要总结

The aim of the described project is to establish a multicenter, nationwide registry of atrial arrhythmia ablation procedures using the Pulsed Field Ablation (PFA) method. These procedures have only recently begun to be performed in several centers across Poland. With proper coordination of the registry, this will enable the consolidation of clinical data and the expansion of knowledge regarding the efficacy and safety of these procedures.

详细描述

Background A relatively recent innovation in cardiac ablation is Pulsed Field Ablation (PFA), a technique based on the phenomenon of irreversible electroporation. This method is tissue-selective, affecting only myocardial cells. Clinical studies have confirmed the efficacy and safety of PFA in the treatment of paroxysmal atrial fibrillation (AF).

Although the catheters currently used for PFA are designed primarily for pulmonary vein isolation (PVI) in AF ablation, there are growing numbers of reports describing their successful application in the ablation of other arrhythmias-such as atrial flutter, atrial tachycardia, and even ventricular tachycardia. However, the efficacy of such procedures has not yet been systematically evaluated in experimental or clinical settings.

We believe that establishing a national registry documenting PFA procedures for atrial arrhythmias will provide valuable insights into the clinical efficacy, safety, and procedural techniques of this emerging treatment strategy. Furthermore, it will support the planning and design of future randomized clinical trials in this area.

Objectives The aim of the project is to establish a multicenter, nationwide registry of PFA-based ablation procedures for arrhythmias other than atrial fibrillation.

Study Design and Planned Procedures The project involves the collection of clinically relevant data from patients undergoing PFA procedures targeting arrhythmias outside the pulmonary veins.

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
否

入选标准

  • •Informed consent obtained from the participant
  • •Subject is undergoing ablation of an atrial arrhythmia using the PFA

排除标准

  • 未提供

结局指标

主要结局

Recurrence of supraventricular arrhythmia

时间窗: 12 months

Recurrence of any supraventricular arrhythmia recorded in the ECG and provided by the participant.

次要结局

未报告次要终点

研究者

发起方
Wroclaw Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stanisław Tubek

MD, PhD

Wroclaw Medical University

研究点 (1)

Loading locations...

相似试验