Renal Denervation In Patient Undergoing VT Ablation:Combined Renal Denervation and VT Ablation vs. Simply VT Ablation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of Patients with adverse events such as recurrens of Ventricular Tachycardias or necessary Intracardiac shocks during 24 months follow up
研究概览
简要总结
Study hypothesis:
With optimal medical therapy and repeated ablations, an additional renal denervation may have protective effects in terms of vegetative intrinsic activity and lead to a significant reduction in VT Burdens.
Study design:
Multicenter, randomized, prospective, single-blind clinical trial.
详细描述
Study protocol:
Catheter ablation of ventricular tachycardia versus combined catheter ablation of ventricular tachycardia and renal denervation.
A total of 50 patients with ventricular tachycardia treated with ICD shocks or ATP will be enrolled in this study. The randomization in the study is done before ablation.
For the ablation, an arterial access is required in both groups. During a 30 minutes waiting time which will apply to both groups, renal denervation will be performed.
In this period of time operators and staff will be blinded for the procedure, thereby they won't know if the patients will receive a renal denervation, in that way the investigators are avoiding a bias of future treatment of the patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Ischemic cardiomyopathy
- •NYHA II-III
- •Recurrent ventricular tachycardia, ICD interventions (shock or ATP)
- •Obtained written informed consent
排除标准
- •Age <18 years
- •Previous VT ablation
- •Cardiopulmonary decompensation within the last 4 weeks
- •Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment
- •History of hemorrhagic diathesis or other coagulopathies
- •Contraindication for oral anticoagulation
- •Hyper- or hypothyroidism
- •Drug or chronic alcohol abuse
- •Has any condition that would make participation not be in the best interest of the subject
- •Incompliance
结局指标
主要结局
Number of Patients with adverse events such as recurrens of Ventricular Tachycardias or necessary Intracardiac shocks during 24 months follow up
时间窗: 24 months
Number of Patients with adverse events such as recurrens of Ventricular
次要结局
- Number of Patients with Ventricular extrasystoles and non-sustained Ventricular Tachycardias compared to the time prior to ablation during 24 months follow up(24 months)
- Number of periprocedural complications(24 months)