跳至主要内容
临床试验/NCT03086902
NCT03086902Unknown不适用

Cryo Ablation vs. Radiofrequency Catheter Ablation for Ventricular Premature Contractions

Sheba Medical Center0 个研究点目标入组 88 人开始时间: 2018年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
88
主要终点
Comparison of successful catheter ablation between both methods.

研究概览

简要总结

Several reports have shown the utility of PVC ablation with cryo catheters. The aim of this study is to compare the outcomes and safety of Cryo vs. RF for PVCs.

详细描述

Background: Radiofrequency (RF) catheter ablation (CA) is an effective therapeutic strategy in eliminating refractory idiopathic ventricular outflow tract (OT) ventricular arrhythmias (VA). However, early and late recurrences occur commonly. RFCA has also been reported to be associated with collateral damage and pain. The use of Cryo ablation as a safer alternative energy source been previously described. In several reports Cryo was reported to successfully treat VA originating from the OT in the absence of ablation related pain and collateral damage to adjacent structures such as the coronaries. When comparing outcomes and complications of catheter ablation of VA from the papillary muscles of the left ventricle with either Cryo or RF, Cryo was found to be associated with significantly higher success rates and lower recurrence rates than RFCA.

Aim: To compare the outcomes and safety of Cryo vs. RF for PVCs. Methods: Patients with PVC VA will be randomized in a 1:1 fashion to RFCA or Cryo ablation. All procedures will be done using a 3-dimensional mapping system (EnSite™ NavX™ system, St. Jude Medical). Ablation will be performed at sites with earliest activation or at least pacemap exhibiting QRS morphology match of >11/12. Endpoint of procedure will be elimination and non inducibility of the clinical VA. All patients will undergo continuous monitoring for at least 12 hours post procedure and 12 lead Holter and exercise testing 1 month post procedure. Successful ablation will be defined as absence of clinical VA or > 50% reduction in arrhythmia burden on Holter in the absence of anti-arrhythmic medications.

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Cryo Ablation

Experimental

PVCs will be mapped and ablated with a Cryo Ablation catheter

干预措施: Cryo Ablation catheter (Device)

Radiofrequency Ablation

Active Comparator

In this arm PVCs will be mapped and ablated with a Radiofrequency Ablation catheter

干预措施: Radiofrequency Ablation Catheter (Device)

结局指标

主要结局

Comparison of successful catheter ablation between both methods.

时间窗: During procedure and 1 month follow up

Successful ablation will be defined as absence of clinical VA or \> 50% reduction in arrhythmia burden on Holter in the absence of anti-arrhythmic medication.

次要结局

  • Comparison of complications such as pericardial effusion/ tamponade, coronary artery damage and post procedure pericardial pain requiring medical management.(During Procedure)
  • Comparison of procedure and fluoroscopy time between both strategies(During Procedure)

研究者

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

Dr. Eyal Nof

Director of Invasive Electrophysiology Service

Sheba Medical Center

相似试验