Invasive and Clinical Features in Patients With Brugada Syndrome Undergoing Catheter Ablation

NCT ID: NCT05685134

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-03
• Study Completion Date: 2025-06-30

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.

Conditions

Brugada Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ablation

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

Group Type: EXPERIMENTAL

Radiofrequency catheter ablation

Intervention Type: DEVICE

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

Control

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

Group Type: SHAM_COMPARATOR

Sham procedure

Intervention Type: DEVICE

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

Interventions

Radiofrequency catheter ablation

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

Intervention Type: DEVICE

Sham procedure

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mauricio Ibrahim Scanavacca

Director of the Cardiac Arrhythmias Unit; MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto do Coração - InCor - HC/FMUSP

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Mauricio Ibrahim Scanavacca, MD; PhD

Role: primary

mauricio.scanavacca@incor.usp.br

+551126615312

Mirella Esmanhotto Facin, MD

Role: backup

mirellafacin@gmail.com

+5511970272217

References

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.

Reference Type: BACKGROUND

PMID: 28500178 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28948234 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35451610 (View on PubMed)

Other Identifiers

IIS-470

Identifier Type: -

Identifier Source: org_study_id