HPvSP-AF Trail: Is High RF Energy Ablation of Atrial Fibrillation Fast, Safe, Less Painful and Effective - a Propensity Score Matched Analysis of 30/25W, 40W and 50W RF Energy Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Procedure time:
研究概览
简要总结
High RF energy ablation of atrial fibrillation is fast, safe, less painful and effective procedure.
详细描述
Atrial fibrillation (AF) ablation is the most commonly performed radiofrequency (RF) ablation and is usually associated with a long procedural time and sensation of pain in conscious patients. Prolonged radiation exposure during the procedure puts the patient and the operator at risk of malignancy and genetic abnormalities. Complications such as asymptomatic cerebral lesions, tamponade, perforation, and also arrhythmia recurrence were associated with longer ablation time.
High-power, shorter-duration radiofrequency ablation (HPSDRFA) appears to be a novel concept for atrial fibrillation (AF) but there are scarce data in conscious patients. The lesion side index (LSI) value has been associated with durability of pulmonary vein isolation (PVI) lesions.
We hypothesised that HPSDRFA applications based on the lesion side index (LSI; its has been associated with durability of pulmonary vein isolation (PVI) lesions) which were not inferior to standard approach regarding safety and effectiveness with shorten procedure time and being less painful for a patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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 patients with non-valvular AF,
- •aged:18-85, first procedure in left atrium,
- •exclusion of thrombus in left atrium and left atrium appendage,
- •left ventricle ejection fraction >55%
排除标准
- •age below 18 or above 85 years,
- •left ventricle ejection fraction<55%,
- •previous procedure in left atrium,
- •valvular AF
结局指标
主要结局
Procedure time:
时间窗: procedure
Total procedure time (needle to needle time).
次要结局
- Voltage mapping time(procedure)
- Total number of RF applications(procedure)
- X-Ray time(procedure)
- Complications(12 months)
- Number of stopped RF applications as a result of pain complained by a patient(procedure)
- Left atrial dwelling time(transeptal access to removal of a catheter and a sheath)
- Total RF time(procedure)
- Follow-up-30s(procedure)
研究者
Maciej Wójcik, MD, PhD
Clinical Professor
Medical University of Lublin