Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Number of radiofrequency applications
研究概览
简要总结
The aim of this single-center prospective randomized controlled trial is to assess the superiority of contact-force-(CF)-sensing-based approach compared to conventional (non-CF-sensing) approach in the catheter ablation of PSVTs, and to investigate the safety of open-irrigated, contact-force-sensing ablation catheters (used in a "non-irrigated" mode) in these procedures.
详细描述
Rationale:
Multiple studies have demonstrated the importance of adequate catheter-tissue contact in the creation of effective lesions during radiofrequency catheter ablation. The development of contact-force(CF)-sensing catheters have contributed significantly to improve clinical outcomes in atrial fibrillation 3-18. However CF-sensing technology is not used in the ablation of paroxysmal supraventricular tachycardia. Although PSVT ablation with the conventional approach (non-irrigated, non-CF-sensing catheters) is considered a relatively low-risk procedure with fairly high success rate (short-and long-term) 1,2,19, we hypothesize that contact-force sensing can further improve the outcomes of these procedures. Based on the results of studies on atrial fibrillation ablation (mentioned above) we believe that CF-sensing could similarly improve such important parameters as radiofrequency (RF) application number/time, total procedure time, and fluoroscopy time in cases of PSVT ablations, as well. In addition CF-sensing could also further improve acute success/recurrence rates of PSVT ablation, and might also be capable to further diminish complication risk.
Primary Objective:
The primary objective of the present study is to demonstrate the superiority of contact-force-sensing in the ablation of AVNRT and WPW-AVRT as assessed by the improvement in the number and duration of radiofrequency applications compared with the conventional ablation approach.
Secondary Objective:
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
- •Referral for electrophysiology study because of pre-excitation on 12-lead surface ECG and/or documented (or suspected) symptomatic PSVT
- •Identification of AVNRT or WPW-AVRT (with manifest or concealed accessory pathway) during standard EP study
- •Verbal consent to continue with ablation therapy
- •Informed written consent to be included in the study
排除标准
- •evidence of structural heart disease and/or myocardial ischemia
- •pregnancy (and lack of exclusion of potential pregnancy)
- •age below 18 years
结局指标
主要结局
Number of radiofrequency applications
时间窗: From the beginning till the end of the ablation procedure
The number of radiofrequency applications during the ablation procedures of AVNRT and WPW-AVRT
次要结局
- (Serious) Adverse Events(Till 12 months)
- Overall duration of radiofrequency applications(From the beginning till the end of the ablation procedure)
- Long-term procedural success(At 12 months)
- Fluoroscopy time(From the beginning till the end of the ablation procedure)
- Acute procedural success/failure(at the end of the ablation procedure)
- Total duration of procedure(From the beginning till the end of the ablation procedure)
- Time to recurrence of AVNRT/WPW-AVRT(up till 12 months)
研究者
Tamás Géczy
Cardiologist
Erasmus Medical Center