"Right Ventricular Outflow Tract Posterior Septum Pacing" in Predicting Ventricular Outflow Tract Ventricular Tachycardia Origin: a Single-center, Prospective, Single Blind, Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Rate of Immediate Ablation Success
研究概览
简要总结
The goal of this clinical trial is to make clear that a new method, right ventricular outflow tract (RVOT) posterior septum pacing, has a greater accuracy in predicting the origin of ventricular outflow tract (VOT) ventricular arrhythmias (VAs) compared to the previous electrocardiographic standards for the identification of the origin of ventricular outflow tract. The secondary aim is to investigate, by using the new method, if it can optimize the procedure of radiofrequency catheter ablation.
Researches will break the method of this investigation into two steps:
First step have enrolled 100 patients. This step would be used to compare the results predicted by right ventricular outflow tract posterior septum pacing, with the previously used electrocardiographic criteria and actual target site.
The second step will enroll another 100 patients. In this step, patients will be divided into two groups, one being the new protocol group and the other being the convention group. Patients will also be followed up, for 1 month and 3 months at outpatient clinic post procedure. Procedure time, success rate, fluoroscopy exposure time and complications, are compared between RVOT posterior septum pacing group and convention group.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent form
- •Age more than 18 years old
- •Able to understand the purpose of the experiment, voluntarily participate, willing to complete follow-up according to the requirement of the experimental protocol.
排除标准
- •Severe cardiopulmonary, liver and kidney dysfunction, and inability to tolerate surgery due to coagulation dysfunction
- •Viral myocarditis, myocardial infarction or stroke with a course of less than six months
- •Simultaneously accompanied by malignant tumours, with an expected lifespan of less than or equal to 1 year
- •Severe thoracic deformity
- •Advanced age (more than 90 years old)
- •Other situations that the researcher deems unsuitable for participation in the study
研究组 & 干预措施
Right Ventricular Outflow Tract (RVOT) Posterior Septum Pacing Group
干预措施: Right Ventricular Outflow Tract Posterior Septum Pacing (Procedure)
Convention Group
干预措施: systemic mapping and ablation (Procedure)
结局指标
主要结局
Rate of Immediate Ablation Success
时间窗: At the end of the first procedure
Immediate Ablation Success is determined by the disappearance of ventricular arrhythmia after ablation, that cannot be induced by electrical stimulation and intravenous infusion of isoproterenol.
Accuracy of RVOT posterior septal pacing protocol
时间窗: At the end of the first procedure
Target site predicted by RVOT posterior septal pacing protocol compared with actual target site and previous ecg criteria
Rate of Ablation Complication
时间窗: At the end of the first procedure
Complications like cardiac tamponade, artery damage
次要结局
- Incidence of Complication(3 months after first procedure)
- Incidence of Complications Post-operative(period of post-operative to hospital discharge, within 7 days)
- Rate of Recurrence during Follow up(3 months after first procedure)
- Incidence of Complication(1 months after first procedure)
- Rate of Recurrence during Follow up(1 months after first procedure)