Sympathetic Denervation by Video-assisted Thoracoscopy in Control of Cardiac Arrhythmias in Patients With Chagas Disease
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A vizsgálat adatai
- Ki végzi
- University of Sao Paulo General Hospital
- Azonosító
- NCT04239144
- A regiszteradat frissítve
- 2026. február 10.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Role of Sympathetic Denervation by Video-assisted Thoracoscopy in Control of Cardiac Arrhythmias in Patients With Chagas Disease - Pilot Study Randomized Controlled Trial
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.
Bevonási feltételek: 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.
Kizáró feltételek: Previous cardiac surgery or scheduled; Unstable angina; Primary severe mitral insufficiency; New York Heart Association (NYHA) functional class IV; Renal insufficiency with creatinine >2.5 mg/dL (221 umol/L); Left Ventricle Ejection fraction < 10%; Presence of an absolute contraindication to receive any of the possible treatments of the study; Pregnant Woman; Less than 18 years-old; Mobile thrombus in the left ventricle; Severe aortic stenosis.