Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome

NCT05685134 | Active Not Recruiting DMC

• 1 other identifier: IIS-470
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, sham-controlled, and blinded clinical trial aims to evaluate the effects of radiofrequency catheter ablation on the phenotypic expression of patients with Brugada syndrome. The main questions it seeks to address are:

• What are the immediate effects of radiofrequency catheter ablation on cardiac electrophysiology?
• Is substrate-directed radiofrequency catheter ablation safe for patients with Brugada syndrome?
• Is substrate-directed epicardial radiofrequency catheter ablation effective in normalizing the electrocardiographic pattern and preventing life-threatening arrhythmic events? Researchers will compare the ablation group with the control group to determine if there are differences in clinical and invasive markers of the disease after one year of follow-up.

Conditions

Brugada Syndrome

Keywords

Brugada syndrome; Radiofrequency catheter ablation; Electroanatomic mapping; Invasive electrophysiological study

Outcome Measures

Primary Outcomes (2)

• Activation recovery interval (ARI)

  The activation recovery interval, which serves as a surrogate marker for the duration of the action potential, will be measured on both the epicardial and endocardial surfaces of the right ventricular outflow tract. This measurement will be taken from the onset of the minimum of the derivative of ventricular activation (dVdT) to the end of ventricular repolarization, following the classic methodology

  First 30 minutes after the intervention

• Area of abnormal electrical potentials measured in square centimeters (cm²)

  Abnormal electrical potentials were defined as low-frequency electrograms (up to 100 Hz) with prolonged duration (\>200 ms), fragmented patterns (more than three deflections), and late components extending beyond the QRS complex

  First 30 minutes after the intervention

Secondary Outcomes (10)

• Local activation time

  First 30 minutes after the intervention

• Maximum potential duration

  First 30 minutes after the intervention

• Induction of sustained ventricular arrhythmias by programmed electrical stimulation

  Immediately (first 30 minutes) after the intervention and again 12 months after

• Acute post-procedure complications

  During the first 72 hours following the intervention

• Spontaneous type 1 Brugada electrocardiographic pattern in standard12 lead and superior leads electrocardiogram

  Up to one year after the procedure

Study Arms (2)

Ablation

EXPERIMENTAL

Radiofrequency catheter ablation of the abnormal - prolonged and fragmented - electrophysiologic substrate of Brugada syndrome

Device: Radiofrequency catheter ablation

Control

SHAM COMPARATOR

Femoral venous punctions, catheter insertion, programmed electrical stimulation and electroanatomic mapping, with a similar duration to the ablation procedure

Device: Sham procedure

Interventions

Radiofrequency catheter ablation DEVICE

Radiofrequency application via catheter to burn the electroanatomic substrate implicated in Brugada syndrome

Ablation

Sham procedure DEVICE

Venous and epicardial punctions, catheter insertions, programmed electrical stimulation and electroanatomical mapping

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

Instituto do Coração - InCor - HC/FMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (3)

• 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.

  PMID: 28500178 BACKGROUND

• 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.

  PMID: 28948234 BACKGROUND

• 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. 2023 Dec;112(12):1715-1726. doi: 10.1007/s00392-022-02020-3. Epub 2022 Apr 22.

  PMID: 35451610 BACKGROUND

MeSH Terms

Conditions

Brugada Syndrome

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomization will occur during the electrophysiology procedure, and the automated process will ensure allocation concealment. Patients randomized to the treatment group will undergo radiofrequency catheter ablation. 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 anonymized before evaluation. The study protocol, for apparent reasons, precludes masking the principal investigator (electrophysiology specialist). Patients, care providers, outcome raters, and statisticians will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Cardiac Arrhythmias Unit; MD, PhD

Model Details: Single-centre, randomized, sham-controlled, and masked pilot study with two parallel arms, with a 1:1 allocation ratio to ablation or control group.

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 13, 2023
• Study Start: November 3, 2020
• Primary Completion: April 7, 2026
• Study Completion: April 7, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the article's publication
• Access Criteria: Under request

Locations

BR (1)