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

February 5, 2026 updated by: Paulo Manuel Pêgo Fernandes, University of Sao Paulo General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Follow up

Outcomes Assessment in six months and one year

  • Recurrence rate of appropriate therapies;
  • Density of ventricular ectopies;
  • Complication rates per type of intervention;
  • Number of in-hospital days per type of intervention;
  • Assessment of LV function;

METHODS

This is a pilot, single-centre, open-label, randomized trial in patients with Chagas disease and multiple appropriate ICD therapies. This study consists of three groups: (1) medical treatment, (2) catheter ablation and (3) bilateral sympathectomy, being included 15 patients in each group.

Inclusion Criteria:

  • 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.

Exclusion criteria:

  • 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.

The patients will be recruited consecutively in the outpatient clinic of Cardiac Pacing Unit, or in outpatient clinic of Arrhythmias Clinical Unit or in the Emergency Clinical Unit.

Group 1 - Medical Treatment: patients allocated to this group will receive amiodarone reimpregnation, incremental dose of beta-blocker and if possible ICD reprogramming.

Group 2 - Catheter ablation: patients allocated to this group will undergo epicardial and endocardial catheter ablation with the use of an 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 (all VTs non-inducible); (2) partial success (clinical VT non inducible, but other morphologies still inducible) and (3) failure (clinical VT still inducible).

Group 3 - Bilateral sympathectomy - bilateral sympathectomy 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. After the application, 10 ml of 0.25% bupivacaine solution will be injected along the site of the pleural dissection for postoperative analgesia. The lung will be reinflated under direct vision and a small tube will be inserted to remove the air through the upper incision, which will be removed at the end of the operation if possible. The two port sites will be closed primarily with absorbable stitches.

The study conformed to the principles outlined in the Declaration of Helsinki and was approved by the ethics committee and institutional review board of our hospital. All patients will provide written informed consent before randomization.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403-900
        • Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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.
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.
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.
Other Names:
  • Cardiac Sympathetic Denervation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Ventricular Tachycardia Recurrence
Time Frame: 12 months
Compare the time to the first documented Ventricular Tachycardia episode between groups
12 months
Burden of Ventricular Tachycardia Recurrence
Time Frame: 12 months
Compare the number of Ventricular Tachycardia episodes between groups in 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ventricular Tachycardia Recurrence Following Sympathectomy Compared to Catheter Ablation.
Time Frame: 12 months
Time to first VT episode after sympathectomy compared to Catheter ablation
12 months
Mortality and Transplant Rate
Time Frame: 12 months
To compare between groups the number of patients who died or received a cardiac transplant at the end of the follow-up
12 months
Ventricular Ectopic Beats Density
Time Frame: 12 months
To evaluate the density of ventricular premature beats in the 24-hour Holter in the follow-up, for each group.
12 months
Length of Hospital Stay
Time Frame: 12 months
Compare the number of in-hospital days according to the type of intervention.
12 months
Rate of Complications Following Intervention
Time Frame: 12 months
Compare the rate of clinical complications according to the type of intervention.
12 months
Impact on Left Ventricular Ejection Fraction
Time Frame: 12 months
To evaluate the variations of the Left Ventricular Ejection Fraction in each group.
12 months
Autonomic Measures
Time Frame: 12 months
To compare the RR variability measures in the 24h-Holter between groups
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biosense Webster, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paulo M Pego Fernandes, MD, PhD, Instituto do Coração Faculdade de Medicina da USP - (INCOR-FMUSP)
  • Study Director: Maurício I Scanavacca, 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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 49701215.2.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be shared with other investigators upon request.

IPD Sharing Time Frame

2 years

IPD Sharing Access Criteria

Upon request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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