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临床试验/NCT04162249
NCT04162249已完成不适用

Feasibility, Safety and Mid-term Efficacy of Pulmonary Vein Isolation by High-power Short-duration Radiofrequency Application: the POWER FAST Pilot Study.

Hospital Universitario La Paz1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2017年9月15日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Sergio Castrejón-Castrejón

Electrophysiologist, co-PI (togheter with Dr. José Luis Merino, main principal investigator)

Hospital Universitario La Paz

研究点 (1)

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