High-power Short-duration Radiofrequency Application for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Total radiofrequency time
研究概览
简要总结
Multicenter 1:1 randomized study. Two atrial fibrillation ablation strategies are compared: 1) conventional ablation using point-by-point radiofrequency applications with power 40 W guided by LSI > 6 or AI > 500 on the anterior aspect of pulmonary veins and power 25 W guided by LSI >5 or AI >350 on the posterior wall near the esophagus; 2) point-by-point RF applications with power set at 70 W and duration 9-10 s. The main objective of the trial is the incidence of esophageal lesions evaluated with systematic endoscopy and clinical efficacy evaluated with daily ECG transtelephonic transmissions during 1-year follow-up. Secondary objectives include total RF time and parameters of acute PV isolation efficacy (first-pass isolation, acute reconnections and dormant conduction).
详细描述
Multicenter 1:1 randomized study: Hospital Universitario La Paz, Madrid; Hospital Clínico Universitario San Carlos, Madrid; Hospital Clínico y Provincial de Barcelona, Barcelona; Complejo Hospitalario de Navarra, Pamplona; Hospital Clínico Universitario de Valladolid; Hospital Clínico Universitario de Albacete; Hospital Clínico Universitario de Alicante; Hospital Universitario Virgen de las Nieves, Granada; Hospital La Fe, Valencia; Hospital Clínico de Valencia; Hospital Universitario Juan Ramón Jiménez, Huelva; Hospital de la Ribera, Alzira, Valencia. España. Spain.
Two atrial fibrillation ablation strategies are compared: 1) conventional ablation using point-by-point radiofrequency applications with power 40 W guided by LSI > 6 or AI > 500 on the anterior aspect of pulmonary veins and power 25-40 W guided by LSI >5 or AI >350 on the posterior wall near the esophagus; 2) point-by-point RF applications with power set at 70 W and duration 9-10 s.
The main objective of the trial is the incidence of esophageal lesions evaluated with systematic endoscopy and clinical efficacy evaluated with daily ECG transtelephonic transmissions during 1-year follow-up. Secondary objectives include total RF time and parameters of acute PV isolation efficacy (first-pass isolation, acute reconnections and dormant conduction).
Subestudy: asymptomatic cerebral lesions detected by 1,5 T MRI <72 h after ablation. Not all centers participate in the subestydy. However, if the center participates, all patients in both ablation groups will be included in the subestudy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal or persistent atrial fibrillation.
- •Currently accepted class I or II indication for ablation according to practice guidelines: symptomatic arrhythmia, failure of at least 1 antiarrhythmic drug or patient's manifest preference of ablation instead of drugs.
- •Age > 18 years.
- •Acceptance of informed consent.
排除标准
- •Previous pulmonary veins ablation of any type.
- •Permanent atrial fibrillation or long-standing persistent AF (>1 year).
- •Heart surgery <3 months before ablation.
- •Coronary revascularization of any type <3 months before ablation.
- •Myocardial infarction or acute coronary syndrome < 3 months before ablation.
- •Stroke or transient cerebral ischaemic attack < 3 months before ablation.
- •Persistent left atrial thrombus.
- •Contraindication for anticoagulation.
- •Absolute indication of double antiplatelet drugs.
- •Complex congenital heart disease, corrected or not.
- •Any clinical situation absolutely precluding an interventional procedure.
结局指标
主要结局
Total radiofrequency time
时间窗: during ablation procedure
Total radiofrequency time required for complete pulmonary veins isolation (included acute intraprocedural reconnections and dormant conduction).
Safety: incidence of esophageal thermal lesions
时间窗: 24 hours after ablation (permissible up to 72 hours after ablation)
Incidence of thermal esophageal lesions evaluated by endoscopy
Efficacy: recurrence of atrial arrhythmias
时间窗: 1 year
Recurrences of any atrial arrhythmias \>30 seconds during 1-year follow-up evaluated by daily transtelephonic ECG transmissions (at least 1 ECG/day and additional transmissions whenever the patient perceives arrhythmia-related symptoms).
次要结局
未报告次要终点
研究者
Dr. Sergio Castrejón-Castrejón
Electrophysiologist, Principal investigator (together with Dr. José Luis Merino)
Hospital Universitario La Paz