search
Back to results

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

Primary Purpose

Chagas Cardiomyopathy, Ventricular Arrythmia

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Bilateral sympathectomy
Catheter ablation
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chagas Cardiomyopathy focused on measuring Ventricular Tachycardia,, Chagas Disease, Catheter Ablation, Bilateral Sympathectomy, Cardiac Sympathetic Denervation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Medical therapy group

Catheter ablation

Bilateral sympathectomy

Arm Description

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.

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).

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.

Outcomes

Primary Outcome Measures

Time to Ventricular Tachycardia Recurrence
Compare the time to the first documented Ventricular Tachycardia episode between groups
Burden of Ventricular Tachycardia Recurrence
Compare the number of Ventricular Tachycardia episodes between groups in 12 months

Secondary Outcome Measures

Ventricular Tachycardia Recurrence Following Sympathectomy Compared to Catheter Ablation.
Time to first VT episode after sympathectomy compared to Catheter ablation
Mortality and Transplant Rate
To compare between groups the number of patients who died or received a cardiac transplant at the end of the follow-up
Ventricular Ectopic Beats Density
To evaluate the density of ventricular premature beats in the 24-hour Holter in the follow-up, for each group.
Length of Hospital Stay
Compare the number of in-hospital days according to the type of intervention.
Rate of Complications Following Intervention
Compare the rate of clinical complications according to the type of intervention.
Impact on Left Ventricular Ejection Fraction
To evaluate the variations of the Left Ventricular Ejection Fraction in each group.
Autonomic Measures
To compare the RR variability measures in the 24h-Holter between groups

Full Information

First Posted
January 23, 2019
Last Updated
May 5, 2023
Sponsor
University of Sao Paulo General Hospital
Collaborators
Biosense Webster, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04239144
Brief Title
Sympathetic Denervation by Video-assisted Thoracoscopy in Control of Cardiac Arrhythmias in Patients With Chagas Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
March 9, 2025 (Anticipated)
Study Completion Date
March 9, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Biosense Webster, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chagas Cardiomyopathy, Ventricular Arrythmia
Keywords
Ventricular Tachycardia,, Chagas Disease, Catheter Ablation, Bilateral Sympathectomy, Cardiac Sympathetic Denervation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medical therapy group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Catheter ablation
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Bilateral sympathectomy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bilateral sympathectomy
Other Intervention Name(s)
Cardiac Sympathetic Denervation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Ventricular Tachycardia Recurrence
Description
Compare the time to the first documented Ventricular Tachycardia episode between groups
Time Frame
12 months
Title
Burden of Ventricular Tachycardia Recurrence
Description
Compare the number of Ventricular Tachycardia episodes between groups in 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Ventricular Tachycardia Recurrence Following Sympathectomy Compared to Catheter Ablation.
Description
Time to first VT episode after sympathectomy compared to Catheter ablation
Time Frame
12 months
Title
Mortality and Transplant Rate
Description
To compare between groups the number of patients who died or received a cardiac transplant at the end of the follow-up
Time Frame
12 months
Title
Ventricular Ectopic Beats Density
Description
To evaluate the density of ventricular premature beats in the 24-hour Holter in the follow-up, for each group.
Time Frame
12 months
Title
Length of Hospital Stay
Description
Compare the number of in-hospital days according to the type of intervention.
Time Frame
12 months
Title
Rate of Complications Following Intervention
Description
Compare the rate of clinical complications according to the type of intervention.
Time Frame
12 months
Title
Impact on Left Ventricular Ejection Fraction
Description
To evaluate the variations of the Left Ventricular Ejection Fraction in each group.
Time Frame
12 months
Title
Autonomic Measures
Description
To compare the RR variability measures in the 24h-Holter between groups
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paulo M Pego Fernandes, PhD
Phone
+551126615921
Email
paulo.fernandes@incor.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo M Kulchetscki, MD
Phone
+551198246-8680‬
Email
r.kulchetscki@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo M Pego Fernandes, MD, PhD
Organizational Affiliation
Instituto do Coração Faculdade de Medicina da USP - (INCOR-FMUSP)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rodrigo M Kulchetscki, MD
Organizational Affiliation
Instituto do Coração Faculdade de Medicina da USP - (INCOR-FMUSP)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maurício I Scanavacca, MD, PhD
Organizational Affiliation
Instituto do Coração Faculdade de Medicina da USP - (INCOR-FMUSP)
Official's Role
Study Director
Facility Information:
Facility Name
Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo M Kulchetscki, MD
Phone
+5511982468680
Email
r.kulchetscki@gmail.com
First Name & Middle Initial & Last Name & Degree
Gabriela Faria, Assistant
Phone
+551126615921
Email
gabriela.faria@incor.usp.br
First Name & Middle Initial & Last Name & Degree
Rodrigo M Kulchetscki, MD
First Name & Middle Initial & Last Name & Degree
Cristiano F Pisani, MD, PhD
First Name & Middle Initial & Last Name & Degree
Muhieddine O Chokr, MD, PhD
First Name & Middle Initial & Last Name & Degree
Lucas G Moura, MD
First Name & Middle Initial & Last Name & Degree
Gabriela Faria, DNP
First Name & Middle Initial & Last Name & Degree
Sergio F Siqueira, ENG
First Name & Middle Initial & Last Name & Degree
Martino Martinelli Filho, MD, PhD
First Name & Middle Initial & Last Name & Degree
Paulo Manoel Pego Fernandes, MD, PhD
First Name & Middle Initial & Last Name & Degree
Mauricio I Scanavacca, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be shared with other investigators upon request.
IPD Sharing Time Frame
2 years
IPD Sharing Access Criteria
Upon request.

Learn more about this trial

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

We'll reach out to this number within 24 hrs