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

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ClinicalTrials.gov Identifier: NCT04239144

Recruitment Status : Recruiting

First Posted : January 23, 2020

Last Update Posted : January 23, 2020

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Sponsor:

Collaborator:

Biosense Webster, Inc.

Information provided by (Responsible Party):

Paulo Manuel Pêgo Fernandes, University of Sao Paulo General Hospital

Study Description

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. Left trunk sympathectomy has been described as an additive treatment of ventricular tachycardia 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 left trunk sympathectomy in the reduction of ventricular tachycardia in patients with Chagas cardiomyopathy. In this pilot study, the investigators will select 30 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, 10 patients in medical therapy group, 10 in catheter ablation and 10 in left sympathectomy.

Condition or disease	Intervention/treatment	Phase
Chagas Cardiomyopathy Ventricular Arrythmia	Procedure: Left trunk sympathectomy Procedure: Catheter ablation	Not Applicable

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Detailed Description:

OBJECTIVE Primary The purpose of this investigation is to evaluate the efficacy of the sympathectomy in the reduction of VT episodes in patients with Chagas cardiomyopathy.

Secondary

To compare the efficacy of sympathectomy with ablation of VT and with the optimal drug 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;
Time of hospitalization per type of intervention;
Rate of inappropriate therapies by ICD;
Assessment of LV function;

METHODS This is a single-centre, pilot, randomized study in patients with Chagas disease and multiple appropriate ICD therapies.

This study consists of three groups: (1) medical treatment, (2) catheter ablation and (3) left sympathectomy, being included 10 patients in each group.

Inclusion Criteria: Patients with chronic Chagas' with at least four appropriate ICD therapies in the last six months; use of amiodarone and beta blockers optimized or maximum tolerated dose treatment; life expectancy of more than one year; Conditions for following the plan of clinical follow-up of the study.

Exclusion criteria: Pregnant Woman; less than 18 years-old; renal insufficiency with creatinine >2.5; mobile thrombus in the left ventricle; ejection fraction of the left ventricle <10%; unstable angina; aortic stenosis, mitral insufficiency with rupture of the package leaflet; functional class of heart failure 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 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.

Group 3 - Left trunk sympathectomy - left truck 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. After the application, 10 ml of 0.25% bupivacaine solution was injected along the site of the pleural dissection for postoperative analgesia. The lung was reinflated under direct vision and a small tube was inserted to remove the air through the upper incision, which was removed at the end of the operation. The two port sites were 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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	In this pilot study, the investigators will select 30 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, 10 patients in medical therapy group, 10 in catheter ablation and 10 in left sympathectomy. The objective of this study is to evaluate the efficacy of the left trunk sympathectomy in the reduction of ventricular tachycardia in patients with Chagas cardiomyopathy.
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Role of Sympathetic Denervation by Video-assisted Thoracoscopy in Control of Cardiac Arrhythmias in Patients With Chagas Disease - Pilot Study Randomized Controlled Trial
Actual Study Start Date :	November 9, 2018
Estimated Primary Completion Date :	December 9, 2020
Estimated Study Completion Date :	December 9, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia Chagas Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Medical therapy group Arm 1 Medical Treatment Control - 10 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 -10 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.	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: Left trunk sympathectomy Interventional arm 3 - In 10 patients, left truck 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.	Procedure: Left trunk sympathectomy left truck 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.

Outcome Measures

Primary Outcome Measures :

Ventricular Tachycardia Recurrence Following sympathectomy [ Time Frame: 12 months ]
Time to first Ventricular tachycardia episode after sympathectomy
Ventricular Tachycardia Recurrence Following sympathectomy - Burden [ Time Frame: 12 months ]
Number of Ventricular Tachycardia episodes after sympathectomy

Secondary Outcome Measures :

Ventricular Tachycardia Recurrence Following sympathectomy compared to catheter ablation. [ Time Frame: 12 months ]
Time to first VT episode after sympathectomy compared to Catheter ablation
Ventricular Ectopy Density [ Time Frame: 12 months ]
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.
Length of Hospital Stay [ Time Frame: Number of days to hospital discharge ]
To evaluate the length of the hospital stay according to the type of intervention.
Rate of complications following intervention [ Time Frame: 12 months ]
The rate of clinical complications according to the type of intervention.
Impact of treatment on left ventricular function - 6 months [ Time Frame: 6 months ]
Left Ventricular Ejection Fraction will be measured 6 months after inclusion
Impact of treatment on left ventricular function - 12 months [ Time Frame: 12 months ]
Left Ventricular Ejection Fraction will be measured 6 months after inclusion
Mortality [ Time Frame: 12 months ]
The number of patients who died at the end of the follow-up

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with chronic Chagas' with at least four appropriate ICD therapies in the last six months;
Use of amiodarone and beta blockers optimized or maximum tolerated dose treatment;
Life expectancy of more than one year;
Conditions for following the plan of clinical follow-up of the study
Signed consent form.

Exclusion Criteria:

Pregnant Woman;
less than 18 years-old;
renal insufficiency with creatinine >2.5;
mobile thrombus in the left ventricle;
ejection fraction of the left ventricle <10%;
unstable angina;
aortic stenosis,
mitral insufficiency with rupture of the package leaflet;
functional class of heart failure IV;
previous cardiac surgery or scheduled.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239144

Contacts

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Contact: Paulo M Pego Fernandes, PhD	+551126615921	paulo.fernandes@incor.usp.br
Contact: Rodrigo G Kulchetscki, MD	+551198246-8680‬	r.kulchetscki@gmail.com

Locations

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Brazil
Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	Recruiting
Sao Paulo, Brazil, 05403-900
Contact: Gabriela Faria, Assistant +551126615921 gabriela.faria@incor.usp.br
Contact: Rodrigo M Kulchetscki, MD +5511 98246-8680‬ r.kulchetscki@gmail.com
Sub-Investigator: Lucas G de Moura, MD
Sub-Investigator: Cristiano F Pisani, MD, PhD
Sub-Investigator: Gabriela F Faria, DNP
Sub-Investigator: Martino M Martinelli, PhD
Sub-Investigator: Sergio Siqueira, ENG
Principal Investigator: Mauricio I Scanavacca, MD, PhD
Principal Investigator: Paulo Manuel P Fernandes, MD, PhD
Sub-Investigator: Lucas Moura, MD

Sponsors and Collaborators

University of Sao Paulo General Hospital

Biosense Webster, Inc.

Investigators

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Principal Investigator:	Paulo M Pego Fernandes, MD, PhD	Instituto do Coração Faculdade de Medicina da USP - (INCOR-FMUSP)
Study Director:	Mauricio I Scanavacca, MD, PhD	Instituto do Coração Faculdade de Medicina da USP - (INCOR-FMUSP)

More Information

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Responsible Party:	Paulo Manuel Pêgo Fernandes, Professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:	NCT04239144
Other Study ID Numbers:	49701215.2.0000.0068
First Posted:	January 23, 2020 Key Record Dates
Last Update Posted:	January 23, 2020
Last Verified:	January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP)
Time Frame:	3, 6 and 12 months

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Paulo Manuel Pêgo Fernandes, University of Sao Paulo General Hospital:


Ventricular Tachycardia, Chagas Disease Catheter Ablation Left Sympathectomy

Additional relevant MeSH terms:

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Chagas Disease Chagas Cardiomyopathy Cardiomyopathies Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases	Pathologic Processes Trypanosomiasis Euglenozoa Infections Protozoan Infections Parasitic Diseases

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