Electroporation vs. Radiofrequency Ablation Guided by 3D Imaging in Repeat Procedures for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Freedom from atrial arrythmia in 12 month observation period
研究概览
简要总结
This is a prospective, randomized clinical trial evaluating the efficacy and safety of two techniques for repeat catheter ablation in patients with recurrent atrial fibrillation (AF): thermal energy ablation (radiofrequency) and non-thermal electroporation (pulsed field ablation), both guided by 3D imaging systems.
Patients undergoing repeat AF ablation will be randomly assigned to receive either thermal or electroporation ablation, performed according to standard hospital protocols. No additional invasive procedures are required. Following the ablation, participants will attend follow-up visits at 3, 6, and 12 months, including medical history review, physical examination, 12-lead ECG, and 24-hour Holter monitoring. Unscheduled ECG assessments will also be available if arrhythmia symptoms occur.
All study-related procedures are non-invasive and align with routine post-ablation care. Risks are limited to those typically associated with standard AF ablation procedures.
The main benefit of participation is close, structured follow-up by experienced electrophysiologists, allowing for early detection of arrhythmia recurrence and timely medical intervention when necessary.
Participant confidentiality and data protection will be ensured in accordance with GDPR regulations.
详细描述
Background Atrial fibrillation (AF) is one of the most common cardiac arrhythmias, with a lifetime risk of approximately 30% in individuals over 55 years of age. A primary treatment option for AF is pulmonary vein isolation (PVI), which targets the anatomical substrate of the arrhythmia. PVI can be achieved using thermal energy-either radiofrequency (RF) ablation or cryoablation-or with the newer, non-thermal method of pulsed field ablation (PFA). PFA delivers sequences of electrical pulses that cause selective electroporation of cardiomyocyte membranes, resulting in cell death while sparing adjacent non-cardiac tissues.
Despite these therapies, AF recurs in 30-50% of patients within the first year after ablation, regardless of the energy source used. The standard management for recurrence involves repeat ablation (re-PVI), targeting pulmonary vein reconnections and atrial substrate identified by electroanatomical mapping.
Randomized controlled trials comparing thermal modalities (RF vs. cryoablation) in first-time PVI have demonstrated similar safety and efficacy. Registry data and a single randomized trial suggest that PFA offers improved safety and comparable efficacy in initial PVI. However, no prospective randomized trial has evaluated the role of PFA in re-PVI.
Re-PVI procedures are technically more complex than index PVI, requiring high-resolution electroanatomical mapping of the left atrium to identify reconnection sites, followed by targeted ablation. While RF remains the established standard, growing evidence suggests that PFA may offer advantages due to its distinct mechanism of action, potentially overcoming thermal resistance from prior ablation. Retrospective data from our institution indicate that PFA may reduce procedure times and improve long-term success compared with RF, though these findings require confirmation in a controlled trial.
Study Overview This dual-center, prospective, randomized trial will compare the feasibility, safety, and efficacy of PFA versus RF ablation for re-PVI in patients with recurrent AF.
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
- 否
入选标准
- •Documented recurrence of AF or atypical atrial flutter after prior PVI Eligibility for re-PVI
排除标准
- •Left ventricular ejection fraction < 30% Left atrial volume index (LAVI) > 72 mL/m² Untreated hyperthyroidism Hypertrophic cardiomyopathy Severe valvular heart disease
研究组 & 干预措施
PFA group
Patients in this arm will undergo 3D-mpping guided re-ablation with the PFA catheter
干预措施: Pulsed field ablation of reccurent atrial arrythmia (Procedure)
RFA group
Patients in this arm will undergo 3D-mpping guided re-ablation with RFA catheter
干预措施: Radiofrequency ablation of reccurent atrial arrythmia (standard of care) (Procedure)
结局指标
主要结局
Freedom from atrial arrythmia in 12 month observation period
时间窗: 12 months observation
PFA is non-inferior to RFA in achieving freedom from documented atrial arrhythmia (AF, atrial flutter, or atrial tachycardia) lasting ≥30 seconds at 12 months after the index ablation procedure, as assessed by 12-lead ECG, 24-hour Holter monitoring, or symptomatic ECG recordings.
次要结局
- Comparison of skin-to-skin time between PFA and RFA group(Data recorded during the procedure)
- Comparison of total fluoroscopy time between PFA and RFA group(Data recorded during the procedure)
- Comparison of total ablation time between PFA and RFA group(Data recorded during the procedure)
- Comparison of total radiation dose between PFA and RFA group(Data recorded during the procedure)
- Safety endpoint(Adverse events during the index procedure and within following 90 days)
研究者
Stanisław Tubek
MD, PhD
Wroclaw Medical University