Feasibility, Safety and Mid-term Efficacy of Pulmonary Vein Isolation by High-power Short-duration Radiofrequency Application: the POWER FAST Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- 1-year efficacy
研究概览
简要总结
The POWER FAST I pilot study is a unicentric, observational, non-randomized controlled clinical study. In the control group pulmonary veins isolation was performded in consecutive patients with irrigated radiofrequency cateters without contact force-sensing capabilities and using conventional low-power and long-duration radiofrequency parameters (20-30 W, 30-60 s) under continuous intracardiac-echo image and esophageal temperature monitoring. The study group consist of consecutive patients distributed in three succesive subgroups. In the study group radiofrequency ablation was performed using a point-by-point technique with contact-force catheters with different high-power and short-duration parameters:
- Subgroup 50W: power 50 W, application duration ≤ 30 s, target lesion index: LSI ≥ 5 or Ablation Index ≥ 350 (posterior wall) or ≥400 (anterior wall).
- Subgroup 60W: power 60 W, application duration 7-10 s, contact force ≥5 g.
- Subgroup 70W: power 70 W, application duration 9 s, contact force ≥5 g.
The safety endpoint was evaluated with systematic esophageal endoscopy performed <72 h after the index procedure. The efficacy endpoint was evaluated:
- during the ablation procedure: acute procedural efficacy, firts-pass isolation of ipsilateral pulmonary veins, total radiofrequency and procedural time, acute reconnections and dormant conduction,
- during the follow-up: any atrial tachycardias documented and longer than 30 s were considered recurrences.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal or persistent AF.
- •Informed consent.
排除标准
- •Previous surgical or catheter-based PVI.
- •Stroke or acute coronary syndrome <6 months before ablation.
- •Terminal comorbidities.
- •Frailty, or clinical instability.
- •Absolute contraindication for oral anticoagulation.
结局指标
主要结局
1-year efficacy
时间窗: One year
Recurrence of atrial arrhythmias \>30 seconds
Clinical feasibility (systematic use of the high-power and short-duration technique)
时间窗: Intraprocedural.
Feasibility of the high-power and short-duration radiofrequency technique.
Incidence of complications
时间窗: < 72 hours after ablation.
Incidence of esophageal thermal lesiones.
Acute efficacy
时间窗: Intraprocedural
Acute pulmonary veins isolation, first-pass isolation, acute reconnections and dormant conduction.
次要结局
- Total radiofrequency time(Intraprocedural)
研究者
Dr. Sergio Castrejón-Castrejón
Electrophysiologist, co-PI (togheter with Dr. José Luis Merino, main principal investigator)
Hospital Universitario La Paz
