Role of Sympathetic Denervation by Video-assisted Thoracoscopy in Control of Cardiac Arrhythmias in Patients With Chagas Disease - Pilot Study Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Time to Ventricular Tachycardia Recurrence
研究概览
简要总结
Ventricular tachycardia (VT) is the main cause of sudden death in patients with structural heart diseases. The use of ICD (implantable cardio-defibrillator) could prevent sudden death, however, the occurrence of repetitive shock decreases significantly the quality of life and could increase the mortality rate. Chagas disease in our environment is the most common heart disease and often associated with the occurrence appropriate ICD therapies.
The chronic treatment of VT aims to prevent recurrences with the use of antiarrhythmic drugs and catheter ablation, but in many cases, these treatments are insufficient to control the VT. Cardiac Sympathetic Denervation by bilateral sympathectomy has been described as an alternative treatment of VT refractory to medical treatment and radiofrequency ablation, especially in patients with channelopathies. This treatment could have a role in patients with structural heart disease.
The objective of this study is to evaluate the efficacy of the bilateral sympathectomy in the reduction of ventricular tachycardia in patients with Chagas cardiomyopathy. In this pilot study, the investigators will select 45 patients with Chagas cardiomyopathy with ICD who presented at least four ICD therapies in the prior six months. These patients will be randomly assigned to three groups, 15 patients in medical therapy group, 15 in catheter ablation and 15 in bilateral sympathectomy.
详细描述
OBJECTIVE
Primary
• Evaluate the efficacy of bilateral sympathectomy in the reduction of VT episodes in patients with Chagas cardiomyopathy.
Secondary
- To compare the efficacy of bilateral sympathectomy against VT ablation and against optimal medical therapy.
- To evaluate the density of ventricular premature beats 24-hour Holter and monitor the events recorded by the ICD and the impact of the treatment performed.
- To evaluate the length of the hospital stay according to the type of intervention.
- To evaluate the rate of clinical complications according to the type of intervention.
- To evaluate the impact of treatment on left ventricular function.
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 with Chagas Disease Cardiomyopathy having an ICD
- •At least four appropriate ICD therapies in the past six months, documented by device interrogation or medical records;
- •Use of amiodarone and beta blockers in an optimized fashion;
- •Life expectancy of more than one year
- •Conditions for following the plan of clinical follow-up of the study.
排除标准
- •Presence of an absolute contraindication to receive any of the possible treatments of the study;
- •Pregnant Woman;
- •Less than 18 years-old;
- •Renal insufficiency with creatinine >2.5 mg/dL (221 umol/L);
- •Mobile thrombus in the left ventricle;
- •Left Ventricle Ejection fraction < 10%;
- •Unstable angina;
- •Severe aortic stenosis
- •Primary severe mitral insufficiency;
- •New York Heart Association (NYHA) functional class IV;
- •Previous cardiac surgery or scheduled.
研究组 & 干预措施
Medical therapy group
Arm 1 - 15 patients allocated to this group will receive conventional antiarrhythmic medical treatment according the guidelines with additional impregnation of amiodarone, incremental dose of beta-blocker and if possible ICD reprograming.
Catheter ablation
Intervention Arm 2 -15 patients allocated to this group will undergo epicardial and endocardial catheter ablation with the use of irrigated contact sensor tip catheter. Voltage electroanatomical mapping using Carto System will be performed in all cases and if hemodynamically stable VT is induced, activation mapping will also be performed. The result of ablation will be defined as (1) complete success (all VTs non-inducible); (2) partial success (clinical VT non inducible, but other morphologies still inducible) and (3) failure (clinical VT still inducible).
干预措施: Catheter ablation (Procedure)
Bilateral sympathectomy
Interventional Arm 3 - 15 patients allocated to this group will undergo bilateral sympathectomy, which will be performed using video assisted thoracoscopy using the Ethicon Ultracision device. The denervation consists of lower 1/3 stellate ganglion and T3- T4 thoracic interspinal space videothoracoscopic cutting, isolating the whole sympathetic chain between these two points using ultracision device on the nerve branches. The cephalic portion of the stellate ganglion will be preserved to avoid Horner's syndrome and the electrocautery use will also be avoided for the same reason. Hemodynamic and echocardiographic behaviors will be continuously monitored during these surgical maneuvers.
干预措施: Bilateral sympathectomy (Procedure)
结局指标
主要结局
Time to Ventricular Tachycardia Recurrence
时间窗: 12 months
Compare the time to the first documented Ventricular Tachycardia episode between groups
Burden of Ventricular Tachycardia Recurrence
时间窗: 12 months
Compare the number of Ventricular Tachycardia episodes between groups in 12 months
次要结局
- Mortality and Transplant Rate(12 months)
- Length of Hospital Stay(12 months)
- Ventricular Tachycardia Recurrence Following Sympathectomy Compared to Catheter Ablation.(12 months)
- Autonomic Measures(12 months)
- Ventricular Ectopic Beats Density(12 months)
- Rate of Complications Following Intervention(12 months)
- Impact on Left Ventricular Ejection Fraction(12 months)
研究者
Paulo Manuel Pêgo Fernandes
Professor
University of Sao Paulo General Hospital