MedTrace Logo

Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome

NCT05685134 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-14

No results posted yet for this study

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

Interventions

DEVICE

Radiofrequency catheter ablation

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

DEVICE

Sham procedure

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

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • University of Sao Paulo General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-03
Primary Completion
2026-04-07
Completion
2026-04-07

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05685134 on ClinicalTrials.gov