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

NCT04239144 | Completed DMC

• 1 other identifier: 49701215.2.0000.0068
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chagas Cardiomyopathy; Ventricular Arrythmia

Keywords

Ventricular Tachycardia,; Chagas Disease; Catheter Ablation; Bilateral Sympathectomy; Cardiac Sympathetic Denervation

Outcome Measures

Primary Outcomes (2)

• Time to Ventricular Tachycardia Recurrence

  Compare the time to the first documented Ventricular Tachycardia episode between groups

  12 months

• Burden of Ventricular Tachycardia Recurrence

  Compare the number of Ventricular Tachycardia episodes between groups in 12 months

  12 months

Secondary Outcomes (7)

• Ventricular Tachycardia Recurrence Following Sympathectomy Compared to Catheter Ablation.

  12 months

• Mortality and Transplant Rate

  12 months

• Ventricular Ectopic Beats Density

  12 months

• Length of Hospital Stay

  12 months

• Rate of Complications Following Intervention

  12 months

Study Arms (3)

Medical therapy group

NO INTERVENTION

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

ACTIVE COMPARATOR

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).

Procedure: Catheter ablation

Bilateral sympathectomy

EXPERIMENTAL

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.

Procedure: Bilateral sympathectomy

Interventions

Bilateral sympathectomy PROCEDURE

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.

Also known as: Cardiac Sympathetic Denervation

Bilateral sympathectomy

Catheter ablation PROCEDURE

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.

Catheter ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biosense Webster, Inc.: collaborator
• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Chagas Cardiomyopathy; Tachycardia, Ventricular; Chagas Disease

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Paulo M Pego Fernandes, MD, PhD

  Instituto do Coração Faculdade de Medicina da USP - (INCOR-FMUSP)

  PRINCIPAL INVESTIGATOR

• Rodrigo M Kulchetscki, MD

  Instituto do Coração Faculdade de Medicina da USP - (INCOR-FMUSP)

  PRINCIPAL INVESTIGATOR

• Maurício I Scanavacca, MD, PhD

  Instituto do Coração Faculdade de Medicina da USP - (INCOR-FMUSP)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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. 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.

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 23, 2020
• Study Start: November 9, 2018
• Primary Completion: November 18, 2025
• Study Completion: December 12, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 years
• Access Criteria: Upon request.

Locations

BR (1)