Safety and Efficacy of Cryotherapy Versus Radiofrequency Ablation for Treatment of Para-hisian Accessory Pathways: a Randomized Comparative Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- One-year recurrence rate
研究概览
简要总结
A randomized pilot study to evaluate safety and efficacy endpoints for treatment of para-hisian accessory pathways according to two different strategies of lesion formation.
These patients will be divided into 2 groups with different strategies of treatment: group 1 treated with radiofrequency (RF) ablation, group 2 with cryotherapy (CRYO).
The primary outcome will be the recurrence rate of accessory pathway conduction after one year of follow-up. Secondary endpoints will be immediate success and rate of permanent atrioventricular (AV) block.
详细描述
This is a randomized study on the safety and efficacy for percutaneous ablation of para-hisian accessory pathways according to two different modalities: radiofrequency (RF) or cryotherapy.
Thirty patients with symptomatic or high-risk para-hisian accessory pathways, documented by previous electrophysiological study (EPS), referred to percutaneous catheter ablation, will be enrolled in this trial.
After informed consent, these patients will be randomized in 2 groups with different current established strategies of invasive treatment. Group I: electrophysiological mapping and ablation with radiofrequency (RF) focal lesion formation.
Group II: electrophysiological mapping and ablation with cryotherapy (CRYO) focal lesion formation.
The primary outcome will be the recurrence rate of accessory pathway conduction after one year of follow-up. Secondary endpoints will be immediate success and rate of permanent atrioventricular (AV) block.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with para-hisian accessory pathways, diagnosed by electrophysiological study (EPS), with indication of invasive treatment according to current guidelines. Patients should be willing and able to sign an informed consent form, and to undergo all procedures described in both the study protocol and the consent form.
排除标准
- •Previous cryotherapy ablation;
- •Previous extensive radiofrequency ablation (including aortic cusp mapping);
- •Age below twelve years;
- •Severe coagulation disorder;
- •Pregnancy;
- •Refusal to participate in the study.
结局指标
主要结局
One-year recurrence rate
时间窗: One year
Recurrence rate of accessory pathway conduction, as assessed by follow-up Clinical recording and event monitoring external device (Holter/Looper).
次要结局
- Rate of atrioventricular block(up to 24 hours)
- Immediate success rate(Time span between vein puncture (start of procedure) and sheath removal (end of procedure), comparing with baseline rhythm)
研究者
Mauricio Ibrahim Scanavacca
Arrhythmia Unit Director - Heart Institute (InCor), MD, PhD
University of Sao Paulo General Hospital