Endocardial-Epicardial Radiofrequency Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Freedom from documented VT episodes
研究概览
简要总结
This is a prospective multicenter randomized open-label study aiming to assess whether endocardial or endocardial-epicardial ablation is superior to the standard approach (i.e., Antiarrhythmic drugs) in achievement of long-term ventricular tachycardia (VT) treatment success.
详细描述
Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy (EPI VT) is a prospective multicenter randomized controlled study that is planned as a pilot study to include 100 patients. The aim of our study is to assess whether endocardial or endocardial-epicardial ablation is superior to the standard approach (i.e., Antiarrhythmic drugs) in the achievement of long-term ventricular tachycardia (VT) treatment success. Patients will be stratified into two groups depending on the history of taking antiarrhythmic medications (AAD) and each group will be further randomized 1:1 for endocardial and epicardial ablation vs endocardial only ablation in group who failed AAD. And in the group who didn't fail AADs patients will be randomized 1:1:1 into 3 groups: endocardial and epicardial ablation, endocardial only ablation or antiarrhythmic medications. Follow up planned at 3, 6 and 12 months, if VT recurrence is noted, repeated procedure (according to initially allocated group) or adjustment of medications (if AAD group) will be performed. Follow up at 3, 6 and 12 months is also planned after a repeat procedure/ medications adjustment.
Primary endpoints include freedom from documented VT episodes (> 30 seconds) at 12 months after the first ablation procedure or on antiarrhythmic medication and freedom from documented VT episodes (>30 seconds) at 12 months after the second ablation procedure or on two antiarrhythmics combined.
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 (Outcomes Assessor)
盲法说明
Due to the nature of the ablation procedures and medications treatment assignment, physicians and patients cannot be blinded to the randomization.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18 or greater
- •Patient with ≥ 1 episode of VT (i.e., Sustained VT more than 30 seconds or VT with any ICD therapy)
- •Patients with ischemic cardiomyopathy, EF less than 50%, documented history of CAD
排除标准
- •Patients with ventricular fibrillation.
- •Reversible causes of VT.
- •Patients with contraindications to systemic anticoagulation with heparin or coumadin, direct thrombin inhibitor or factor Xa inhibitors.
- •Patients with prior procedure involving opening the pericardium or entering the pericardial space (e.g., CABG, heart transplantation, valve surgery) were adhesions are suspected
- •Any prior ablation for the ventricles or any prior epicardial ablation
- •Documented history of myocardial infarction within 1 month prior to the planned study intervention
- •Documented symptomatic carotid disease defined as > 70% stenosis or > 50% stenosis with symptoms
- •Any history of thoracic radiation with the exception of localized radiation treatment for breast cancer
- •Active pericarditis
- •Active endocarditis\Any documented history or autoimmune disease associated with pericarditis
- •Thrombocytopenia (platelet count < 100 x 109/L)
- •Body Mass Index (BMI > 45)
- •Patients who are pregnant.
- •Pregnancy will be assessed by urine pregnancy testing prior to the ablation procedure
研究组 & 干预措施
Patients who didn't fail AAD
This group of patients will be randomized to 3 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation; 3) Antiarrhythmic medications
干预措施: Endocardial ablation (Procedure)
Patients who didn't fail AAD
This group of patients will be randomized to 3 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation; 3) Antiarrhythmic medications
干预措施: Endocardial- Epicardial ablation (Procedure)
Patients who didn't fail AAD
This group of patients will be randomized to 3 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation; 3) Antiarrhythmic medications
干预措施: Antiarrhythmic medications (Drug)
Patients who failed AAD
This group of patients will be randomized to 2 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation
干预措施: Endocardial ablation (Procedure)
Patients who failed AAD
This group of patients will be randomized to 2 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation
干预措施: Endocardial- Epicardial ablation (Procedure)
结局指标
主要结局
Freedom from documented VT episodes
时间窗: 12 months
Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the first ablation procedure or on antiarrhythmic medication.
Freedom from documented VT episodes after second intervention
时间窗: 12 months after second intervention
Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the second ablation procedure or on two antiarrhythmics combined.
次要结局
- Number of repeat procedures(12, 24 months)
- Cost-effectiveness analysis(12 months)
- Long-term follow-up to evaluate freedom of documented VT episodes(24 and 60 months)
- Incidence of peri-procedural and 12-month post procedural complications,(12 months)
- Procedure duration and fluoroscopy time(Up to 4 hours (During ablation procedure))