Clinical trial NCT05685134: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Brugada Syndrome
Keywords: Brugada syndrome
Radiofrequency catheter ablation
Electroanatomic mapping
Invasive electrophysiological study
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2023-01-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Area of abnormal potentials
timeFrame: first 30 minutes after the intervention
measure: Induction of sustained ventricular arrhythmias by programmed electrical stimulation
timeFrame: first 30 minutes after the intervention
measure: Maximum potential duration
timeFrame: first 30 minutes after the intervention
measure: Local activation time
timeFrame: first 30 minutes after the intervention
measure: Activation recovery interval
timeFrame: first 30 minutes after the intervention
Secondary outcomes:
measure: Spontaneous type 1 Brugada electrocardiographic pattern in standard12 lead and superior leads electrocardiogram
timeFrame: up to one year after the procedure
measure: Spontaneous type 1 Brugada electrocardiographic pattern in 12 lead 24 hour Holter monitoring
timeFrame: up to one year after the procedure
measure: Spontaneous type 1 Brugada electrocardiographic pattern during treadmill test
timeFrame: up to one year after the procedure
measure: Occurrence of life threatening arrhythmic events
timeFrame: up to one year after the procedure
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração - InCor - HC/FMUSP
Study officials:
References:
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.
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.
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. 2023 Dec;112(12):1715-1726. doi: 10.1007/s00392-022-02020-3. Epub 2022 Apr 22.