Back to resultsInvasive and Clinical Features in Patients With Brugada Syndrome Undergoing Catheter Ablation
Primary Purpose
Brugada Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Radiofrequency catheter ablation
Sham procedure
Sponsored by
About this trial
This is an interventional treatment trial for Brugada Syndrome focused on measuring Brugada syndrome, Radiofrequency catheter ablation, Electroanatomic mapping, Invasive electrophysiological study
Eligibility Criteria
Inclusion Criteria: Patients with a type 1 Brugada ECG pattern, as characterized by ST-segment elevation (≥2mm) with upward concavity associated with T-wave inversion, in at least one of the right precordial leads, positioned at the second, third or fourth intercostal space, either spontaneously or induced by a provocative test with Class I anti-arrhythmic drugs according to Vaughan Williams Patients clinically stable for at least six months before the enrollment Able to cope with follow-up visits up to one year after the intervention Patients who have signed the written informed consent Exclusion Criteria: Pregnant women Patients with structural heart disease Patients with a known cardiac or systemic autonomic disorder Patients with a history of previous right ventricular outflow tract ablation
Sites / Locations
- Instituto do Coração - InCor - HC/FMUSPRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Ablation
Control
Arm Description
Radiofrequency catheter ablation of the abnormal - prolonged and fragmented - electrophysiologic substrate of Brugada syndrome
Femoral venous punctions, catheter insertion, programmed electrical stimulation and electroanatomic mapping, with a similar duration to the ablation procedure
Outcomes
Primary Outcome Measures
Area of abnormal potentials
Electroanatomic duration map
Induction of sustained ventricular arrhythmias by programmed electrical stimulation
Programmed electrical stimulation (PES) performed on two sites (right ventricular apex and right ventricular outflow tract, unless the patient had inducible ventricular tachycardia at the first location), with energy of twice the diastolic threshold, using two drive cycles (S1: 600 and 430 ms) up to 3 extra stimuli (S2 to S4) with 200 ms as the shortest coupling time. The PVS result is considered positive if sustained ventricular fibrillation or polymorphic ventricular tachycardia is induced.
Maximum potential duration
Maximum length of ventricular signs on bipolar electrogram
Local activation time
Measured by unipolar catheters placed in the epicardial and endocardial ventricular surfaces
Activation recovery interval
Surrogate marker of the action potential duration, measured by unipolar catheters placed in the epicardial and endocardial ventricular surfaces
Secondary Outcome Measures
Spontaneous type 1 Brugada electrocardiographic pattern in standard12 lead and superior leads electrocardiogram
Upward ST segment elevation ST-segment elevation ≥2 mm followed by a negative T wave (type 1 Brugada electrocardiographic pattern) in one or more right precordial leads V1 and/or V2 positioned in the second, third, or fourth intercostal spaces.
Spontaneous type 1 Brugada electrocardiographic pattern in 12 lead 24 hour Holter monitoring
Upward ST segment elevation ST-segment elevation ≥2 mm followed by a negative T wave (type 1 Brugada electrocardiographic pattern) in one or more right precordial leads V1 and/or V2 positioned in the second, third, or fourth intercostal spaces during 12 lead 24h Holter ECG Monitoring
Spontaneous type 1 Brugada electrocardiographic pattern during treadmill test
Upward ST segment elevation ST-segment elevation ≥2 mm followed by a negative T wave (type 1 Brugada electrocardiographic pattern) in one or more right precordial leads V1 and/or V2 positioned in the second, third, or fourth intercostal spaces, during treadmill test.
Occurrence of life threatening arrhythmic events
Occurrence of at least one of the following: arrhythmic syncope, documented sustained ventricular tachycardia or ventricular fibrillation, sudden cardiac death or appropriate implantable cardiac defibrillator therapy
Full Information
NCT ID
NCT05685134
First Posted
December 21, 2022
Last Updated
January 6, 2023
Sponsor
University of Sao Paulo General Hospital
Collaborators
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05685134
Brief Title
Invasive and Clinical Features in Patients With Brugada Syndrome Undergoing Catheter Ablation
Official Title
Invasive and Clinical Features in Patients With Brugada Syndrome Undergoing Catheter Ablation: a Prospective, Single-centre, Randomized, Sham-controlled, and Masked Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical trial aims to learn about the electrophysiological and clinical effects of radiofrequency catheter ablation in patients with Brugada syndrome. The main questions it seeks to answer are:
What are the immediate effects of catheter radiofrequency ablation in cardiac electrophysiology?
What is the relation between invasive and clinical features in patients with Brugada syndrome undergoing ablation? Researchers will compare ablation and control groups to see if there is a difference in clinical and invasive markers of the disease in one year of follow-up.
Detailed Description
Brugada syndrome (BS) is an electric cardiac disorder characterized by a typical electrocardiographic pattern and an increased risk of cardiac arrhythmias and sudden death. Most arrhythmic events occur during rest, fever or under circumstances of increased vagal activity. In the last decade, catheter ablation has emerged as a valuable and potentially curative therapy for patients with BS. However, little is known about its mechanisms or long-term effects on clinical and invasive markers. This prospective, single-centre, randomized, sham-controlled, and masked pilot study will investigate the impact of catheter ablation in 20 patients with Brugada syndrome, who will be randomized to ablation or control group, with a 1:1 allocation ratio and clinically followed for 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brugada Syndrome
Keywords
Brugada syndrome, Radiofrequency catheter ablation, Electroanatomic mapping, Invasive electrophysiological study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, single-centre, randomized, sham-controlled, and masked pilot study with two parallel arms, with a 1:1 allocation ratio to ablation or control group.
Masking
ParticipantOutcomes Assessor
Masking Description
Randomization will occur during the electrophysiology procedure, and its automatic computerized process will ensure allocation concealment. The study protocol, for obvious reasons, precludes masking the principal investigator (electrophysiology specialist). Participants randomized to the control group will undergo a sham procedure consisting of femoral venous punctions, catheter insertion, programmed electrical stimulation and electroanatomic mapping, with a similar duration to the ablation procedure. Medical follow-up will be standardized with the same protocol for both treatment groups. All medical documents will be unidentified before being evaluated. Outcome raters and statisticians will also be blinded.
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ablation
Arm Type
Experimental
Arm Description
Radiofrequency catheter ablation of the abnormal - prolonged and fragmented - electrophysiologic substrate of Brugada syndrome
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Femoral venous punctions, catheter insertion, programmed electrical stimulation and electroanatomic mapping, with a similar duration to the ablation procedure
Intervention Type
Device
Intervention Name(s)
Radiofrequency catheter ablation
Intervention Description
Radiofrequency application via catheter to burn the electroanatomic substrate implicated in Brugada syndrome
Intervention Type
Device
Intervention Name(s)
Sham procedure
Intervention Description
Venous and epicardial punctions, catheter insertions, programmed electrical stimulation and electroanatomical mapping
Primary Outcome Measure Information:
Title
Area of abnormal potentials
Description
Electroanatomic duration map
Time Frame
first 30 minutes after the intervention
Title
Induction of sustained ventricular arrhythmias by programmed electrical stimulation
Description
Programmed electrical stimulation (PES) performed on two sites (right ventricular apex and right ventricular outflow tract, unless the patient had inducible ventricular tachycardia at the first location), with energy of twice the diastolic threshold, using two drive cycles (S1: 600 and 430 ms) up to 3 extra stimuli (S2 to S4) with 200 ms as the shortest coupling time. The PVS result is considered positive if sustained ventricular fibrillation or polymorphic ventricular tachycardia is induced.
Time Frame
first 30 minutes after the intervention
Title
Maximum potential duration
Description
Maximum length of ventricular signs on bipolar electrogram
Time Frame
first 30 minutes after the intervention
Title
Local activation time
Description
Measured by unipolar catheters placed in the epicardial and endocardial ventricular surfaces
Time Frame
first 30 minutes after the intervention
Title
Activation recovery interval
Description
Surrogate marker of the action potential duration, measured by unipolar catheters placed in the epicardial and endocardial ventricular surfaces
Time Frame
first 30 minutes after the intervention
Secondary Outcome Measure Information:
Title
Spontaneous type 1 Brugada electrocardiographic pattern in standard12 lead and superior leads electrocardiogram
Description
Upward ST segment elevation ST-segment elevation ≥2 mm followed by a negative T wave (type 1 Brugada electrocardiographic pattern) in one or more right precordial leads V1 and/or V2 positioned in the second, third, or fourth intercostal spaces.
Time Frame
up to one year after the procedure
Title
Spontaneous type 1 Brugada electrocardiographic pattern in 12 lead 24 hour Holter monitoring
Description
Upward ST segment elevation ST-segment elevation ≥2 mm followed by a negative T wave (type 1 Brugada electrocardiographic pattern) in one or more right precordial leads V1 and/or V2 positioned in the second, third, or fourth intercostal spaces during 12 lead 24h Holter ECG Monitoring
Time Frame
up to one year after the procedure
Title
Spontaneous type 1 Brugada electrocardiographic pattern during treadmill test
Description
Upward ST segment elevation ST-segment elevation ≥2 mm followed by a negative T wave (type 1 Brugada electrocardiographic pattern) in one or more right precordial leads V1 and/or V2 positioned in the second, third, or fourth intercostal spaces, during treadmill test.
Time Frame
up to one year after the procedure
Title
Occurrence of life threatening arrhythmic events
Description
Occurrence of at least one of the following: arrhythmic syncope, documented sustained ventricular tachycardia or ventricular fibrillation, sudden cardiac death or appropriate implantable cardiac defibrillator therapy
Time Frame
up to one year after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a type 1 Brugada ECG pattern, as characterized by ST-segment elevation (≥2mm) with upward concavity associated with T-wave inversion, in at least one of the right precordial leads, positioned at the second, third or fourth intercostal space, either spontaneously or induced by a provocative test with Class I anti-arrhythmic drugs according to Vaughan Williams
Patients clinically stable for at least six months before the enrollment
Able to cope with follow-up visits up to one year after the intervention
Patients who have signed the written informed consent
Exclusion Criteria:
Pregnant women
Patients with structural heart disease
Patients with a known cardiac or systemic autonomic disorder
Patients with a history of previous right ventricular outflow tract ablation
Facility Information:
Facility Name
Instituto do Coração - InCor - HC/FMUSP
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauricio Ibrahim Scanavacca, MD; PhD
Phone
+551126615312
Email
mauricio.scanavacca@incor.usp.br
First Name & Middle Initial & Last Name & Degree
Mirella Esmanhotto Facin, MD
Phone
+5511970272217
Email
mirellafacin@gmail.com
First Name & Middle Initial & Last Name & Degree
Cristiano Pisani, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sharing will be provided under proper request to the principal investigator
IPD Sharing Time Frame
After the article's publication
IPD Sharing Access Criteria
Under request
Citations:
PubMed Identifier
28500178
Citation
Pappone C, Brugada J, Vicedomini G, Ciconte G, Manguso F, Saviano M, Vitale R, Cuko A, Giannelli L, Calovic Z, Conti M, Pozzi P, Natalizia A, Crisa S, Borrelli V, Brugada R, Sarquella-Brugada G, Guazzi M, Frigiola A, Menicanti L, Santinelli V. Electrical Substrate Elimination in 135 Consecutive Patients With Brugada Syndrome. Circ Arrhythm Electrophysiol. 2017 May;10(5):e005053. doi: 10.1161/CIRCEP.117.005053.
Results Reference
background
PubMed Identifier
28948234
Citation
Patocskai B, Yoon N, Antzelevitch C. Mechanisms Underlying Epicardial Radiofrequency Ablation to Suppress Arrhythmogenesis in Experimental Models of Brugada Syndrome. JACC Clin Electrophysiol. 2017 Apr;3(4):353-363. doi: 10.1016/j.jacep.2016.10.011. Epub 2016 Dec 21.
Results Reference
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PubMed Identifier
35451610
Citation
Kotake Y, Barua S, Kazi S, Virk S, Bhaskaran A, Campbell T, Bennett RG, Kumar S. Efficacy and safety of catheter ablation for Brugada syndrome: an updated systematic review. Clin Res Cardiol. 2022 Apr 22. doi: 10.1007/s00392-022-02020-3. Online ahead of print. Erratum In: Clin Res Cardiol. 2023 Jun;112(6):853.
Results Reference
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Invasive and Clinical Features in Patients With Brugada Syndrome Undergoing Catheter Ablation
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