Application of High Power Radio Frequency Energy in the Interventional Treatment of Patients With Ventricular Tachycardia and Structural Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 12
- 主要终点
- The number of episodes of ICD therapy
研究概览
简要总结
Background: Patient's freedom from VT after RFA remains non-optimal and it depends on many factors. One of them is the effective reduction of the myocardium with RF energy during the operation. The standardization of the parameters of RF will help to increase the success of the procedure.
Hypothesis: Radiofrequency ablation of ventricular tachycardias with high power parameters has comparable safety and leads to greater efficacy (absence of ventricular tachycardias and all types of cardioverter-defibrillator therapies) in the long-term compared with ablation with standard parameters in patients with structural heart disease.
Purpose: to evaluate the safety and the efficiency of ablation of ventricular tachycardia in patients with structural heart disease using high power RF energy.
详细描述
Background: Patient's freedom from VT after RFA remains non-optimal and it depends on many factors. One of them is the effective reduction of the myocardium with RF energy during the operation. The standardization of the parameters of RF will help to increase the success of the procedure.
Hypothesis
Radiofrequency ablation of ventricular tachycardias with high power parameters has comparable safety and leads to greater efficacy (absence of ventricular tachycardias and all types of cardioverter-defibrillator therapies) in the long-term compared with ablation with standard parameters in patients with structural heart disease.
Purpose: to evaluate the safety and the efficiency of ablation of ventricular tachycardia in patients with structural heart disease using high power RF energy.
Tasks:
- To analyze the number of intraoperative complications in both groups
- To evaluate the number of recurrent ventricular tachycardias and the number of episodes of CDI therapy in the long-term follow-up period
- To estimate the time of onset of the first episode of VT and the overall burden of VT in the long-term follow-up period
- To compare the total time of surgery, fluoroscopy, the number and total time of RF exposure, as well as the ablation index in relation to the "acute" and separated efficiency of ablation in the study groups
- To estimate all-cause mortality in both groups
- The number of repeated ablation for recurrent VT
- The number of justified and unfounded CDI therapies
- To analyze the long-term burden of antiarrhythmic therapy
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
- •Patients after myocardial infarction (at least 3 months before enrollment in the study)
- •Stable, documented, monomorphic VT, confirmed by ECG and / or CMECG and / or EGM of any implanted device, having appropriate rhythm discrimination algorithms
- •Patients who have signed the informed consent
排除标准
- •Acute myocardial ischemia
- •A reversible cause of VT (e.g. drug arrhythmia), recently(up to 30 days) suffered from acute coronary syndrome, coronary revascularization (<90 days for bypass surgery, <30 days for percutaneous coronary intervention), or having functional class IV angina.
- •Thrombosis of the left ventricle
- •Patients who have been implanted the mechanical prostheses in the aortic and mitral positions.
- •Patients who have been performed the catheter RFA for VT.
- •Renal failure (creatinine clearance <15 ml / min),
- •Patients with NYHA functional class IV heart failure
- •Patients with a medical condition that may limit survival to less than 1 year
- •Patients with myocardial infarction with ST-segment elevation or MI without ST-segment elevation, transferred less than 30 days ago.
- •Patients who haven't signed the informed consent
结局指标
主要结局
The number of episodes of ICD therapy
时间窗: Up to one year
The number of episodes of ICD therapy on one-year follow-up period after single procedure
The inducibility of the clinical VT at the end of ablation procedure
时间窗: Day 1
The number of patients with inducible VT at the end of the ablation procedure
The number of recurrent ventricular tachycardias
时间窗: Up to one year
The number of recurrent ventricular tachycardias on one-year follow-up period after single procedure
The number of intraoperative complications
时间窗: Day 1
The number of intraoperative complications (death, hemopericardium, stroke, heart attack, electrical storm, vascular complications)
次要结局
- Freedom from recurrent VT(3 months)
- The total time of fluoroscopy(Up to one year)
- The total number of RF exposures(Up to one year)
- The number of redo ablation procedures for recurrent VT(Up to one year)
- The number of antiarrhythmic drugs(Up to one year)
- The number of appropriate and unappropriated ICD therapies(Up to one year)
- The total time of ablation procedure(Up to one year)
- The total time of RF exposures(Up to one year)
- All-cause mortality(Up to one year)