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

University of Sao Paulo General Hospital

Status: Enrolling

Conditions: Brugada Syndrome

Treatments: Device: Radiofrequency catheter ablation; Device: Sham procedure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05685134

IIS-470

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups

Ablation

Experimental group

Description:

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

Treatment:

Device: Radiofrequency catheter ablation

Control

Sham Comparator group

Description:

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

Treatment:

Device: Sham procedure