Sympathetic Denervation by Video-assisted Thoracoscopy in Control of Cardiac Arrhythmias in Patients With Chagas Disease

NARecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

November 9, 2018

Primary Completion Date

March 9, 2025

Study Completion Date

March 9, 2026

Conditions
Chagas CardiomyopathyVentricular Arrythmia
Interventions
PROCEDURE

Bilateral sympathectomy

Bilateral sympathectomy will be performed using video assisted thoracoscopy using the Ethicon Ultracision device. The denervation consisted of left 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 was preserved to avoid Horner's syndrome and the electrocautery use was also avoided due to the same reason. The nerve was blocked using Ultracision device to avoid thermic lesion of the stellate ganglion. Hemodynamic and echocardiographic behaviors were continuously monitored during these surgical maneuvers.

PROCEDURE

Catheter ablation

Catheter ablation - patients allocated to this group will undergone 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 aim of the ablation is to eliminate the clinical VT additionally to substrate modification. The result of ablation will be defined as (1) complete success; (2) partial success and (3) failure.

Trial Locations (1)

05403-900

RECRUITING

Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo

All Listed Sponsors
collaborator

Biosense Webster, Inc.

INDUSTRY

lead

University of Sao Paulo General Hospital

OTHER