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

Brugada Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05685134
• Other study ID #: IIS-470
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2020
• Est. completion date: June 2025

Study information

• Verified date: January 2023
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brugada Syndrome
• Syndrome

Intervention

Device:
• Radiofrequency catheter ablation
Radiofrequency application via catheter to burn the electroanatomic substrate implicated in Brugada syndrome
• Sham procedure
Venous and epicardial punctions, catheter insertions, programmed electrical stimulation and electroanatomical mapping

Locations

Country	Name	City	State
Brazil	Instituto do Coração - InCor - HC/FMUSP	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Biosense Webster, Inc.

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. 2022 Jun 2;: — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area of abnormal potentials	Electroanatomic duration map	first 30 minutes after the intervention
Primary	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.	first 30 minutes after the intervention
Primary	Maximum potential duration	Maximum length of ventricular signs on bipolar electrogram	first 30 minutes after the intervention
Primary	Local activation time	Measured by unipolar catheters placed in the epicardial and endocardial ventricular surfaces	first 30 minutes after the intervention
Primary	Activation recovery interval	Surrogate marker of the action potential duration, measured by unipolar catheters placed in the epicardial and endocardial ventricular surfaces	first 30 minutes after the intervention
Secondary	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.	up to one year after the procedure
Secondary	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	up to one year after the procedure
Secondary	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.	up to one year after the procedure
Secondary	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	up to one year after the procedure