Comparison of Different Electroporation Systems in the Ablation Treatment of Atrial Fibrillation
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
- 4
- 主要终点
- Effectiveness and durability of the ablation procedure.
研究概览
简要总结
The participant is invited to participate in a clinical study comparing three different techniques for treating atrial fibrillation (AF) called electroporation systems. Atrial fibrillation is an irregular heartbeat that can cause complications if left untreated. The goal of this study is to determine which electroporation system is the most effective and safest for treating AF. These systems work by using electrical energy to disrupt abnormal heart tissue, helping to restore a normal heart rhythm.
详细描述
The investigators are testing three different electroporation systems: Farapulse, PulseSelect, and Varipulse. Each of these systems uses a similar approach to treat AF, but they may work slightly differently. The investigators want to find out which one is best at permanently stopping the irregular heart rhythm, while also being the safest for patients.
What will happen during the study?
The patient will have two procedures:
First procedure: This is the initial ablation, where the doctors will use one of the three electroporation systems to treat the atrial fibrillation. During this procedure, the investigators will map the heart using a special tool to see exactly where the irregular rhythm is happening.
Second procedure: After about 3 months, the participant will return for a re-mapping procedure. This will allow the doctors to check if the treatment was successful and if any abnormal rhythms have come back. If necessary, the investigator will perform another ablation to correct any remaining problems.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with symptomatic paroxysmal or persistent atrial fibrillation. Eligible for catheter ablation as per current guidelines. Willing to undergo both an initial ablation procedure and a repeat mapping/ablation if required.
排除标准
- •Patients with prior ablation procedures. Contraindications for AF ablation (e.g., severe coagulopathy, left atrial appendage thrombus).
- •Significant comorbidities impacting study outcomes.
结局指标
主要结局
Effectiveness and durability of the ablation procedure.
时间窗: Three months
The percentage of patients who achieve complete and durable pulmonary vein isolation without reconnection, confirmed during the re-mapping procedure performed approximately 12-14 weeks after the initial ablation.
次要结局
未报告次要终点
研究者
Ana Jordan
Principal Investigator
University Hospital Dubrava