Role of Sympathetic Denervation by Video-assisted Thoracoscopy in Control of Cardiac Arrhythmias in Patients With Chagas Disease - Pilot Study Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Paulo M Pego Fernandes, PhD
paulo.fernandes@incor.usp.br
+551126615921
Backup
Rodrigo M Kulchetscki, MD
r.kulchetscki@gmail.com
+551198246-8680‬
Time Frame
Start Date: 2018-11-09
Estimated Completion Date: 2026-03-09
Participants
Target number of participants: 45
Treatments
No_intervention: 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.
Active_comparator: 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).
Experimental: 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.
Authors
Martino M Martinelli, Sergio Siqueira
Sponsors
Leads: University of Sao Paulo General Hospital
Collaborators: Biosense Webster, Inc.

This content was sourced from clinicaltrials.gov

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