NCT06878924尚未招募不适用
Safety and Efficacy of Pulmonary Vein Isolation Using Pulsed-field Ablation (PFA) Combined with Either PFA-based Left Atrial Posterior Wall Isolation or Vein of Marshall Ethanol Ablation in Patients with Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 162
- 主要终点
- Recurrence of atrial arrhythmia: any episode of AF/AT longer than 30 sec off-AAD, after the 2-month blanking period
研究概览
简要总结
This study is designed to directly compare the safety and efficacy of PFA-based PVI+PWI vs PFA-based PVI+ VoM alcohol ablation in patients with Persistent AF.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Symptomatic persistent AF; 1st or redo ablation with PVI-only in the earlier procedure
- •Willing to provide informed consent
- •Age: 18-85 years
排除标准
- •• Previous PWI or VoM ablation procedure
- •Left ventricular ejection fraction <40%
- •Left atrial thrombus
- •Myocardial infarction within last 60 days
- •Cardiac surgery in the last 6 months
- •Advanced renal failure
- •Life expectancy <1 year
- •Pregnant women
- •Unable or unwilling to provide informed consent
结局指标
主要结局
Recurrence of atrial arrhythmia: any episode of AF/AT longer than 30 sec off-AAD, after the 2-month blanking period
时间窗: 1 year
次要结局
- • Arrhythmia-free on previously ineffective AAD without any dose-escalation(1 year)
研究者
Andrea Natale
Executive Medical Director
Texas Cardiac Arrhythmia Research Foundation
相似试验
Unknown
4 期
Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drug Treatment in Subjects With Recurrent Atrial FibrillationAtrial FibrillationNCT02475642VZW Cardiovascular Research Center Aalst152
终止
不适用
Comparison of PVI Plus Catheter Ablation or PVI Alone for the Treatment of AFib for Patients With Paroxysmal Atrial FibrillationAtrial FibrillationNCT03115554Wake Forest University Health Sciences2
进行中（未招募）
4 期
SINGLE SHOT CHAMPIONParoxysmal Atrial FibrillationNCT05534581Insel Gruppe AG, University Hospital Bern210
进行中（未招募）
不适用
Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AFPersistent Atrial FibrillationNCT04505163Dignity Health Medical Foundation153
终止
不适用
Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial FibrillationAtrial Fibrillation ParoxysmalNCT06364215Jorge Romero198