Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04239144
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Paulo Manuel Pêgo Fernandes, University of Sao Paulo General Hospital

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

Show Show detailed description

Layout table for study information
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


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.




Primary Outcome Measures :
  1. Ventricular Tachycardia Recurrence Following sympathectomy [ Time Frame: 12 months ]
    Time to first Ventricular tachycardia episode after sympathectomy

  2. Ventricular Tachycardia Recurrence Following sympathectomy - Burden [ Time Frame: 12 months ]
    Number of Ventricular Tachycardia episodes after sympathectomy


Secondary Outcome Measures :
  1. Ventricular Tachycardia Recurrence Following sympathectomy compared to catheter ablation. [ Time Frame: 12 months ]
    Time to first VT episode after sympathectomy compared to Catheter ablation

  2. 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.

  3. 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.

  4. Rate of complications following intervention [ Time Frame: 12 months ]
    The rate of clinical complications according to the type of intervention.

  5. Impact of treatment on left ventricular function - 6 months [ Time Frame: 6 months ]
    Left Ventricular Ejection Fraction will be measured 6 months after inclusion

  6. Impact of treatment on left ventricular function - 12 months [ Time Frame: 12 months ]
    Left Ventricular Ejection Fraction will be measured 6 months after inclusion

  7. Mortality [ Time Frame: 12 months ]
    The number of patients who died at the end of the follow-up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

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

Locations
Layout table for location information
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
Layout table for investigator information
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)

Layout table for additonal information
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

Layout table for additional information
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:
Layout table for MeSH terms
Chagas Disease
Chagas Cardiomyopathy
Cardiomyopathies
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases