Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 5:10 AM
Study NCT ID:
NCT05685134
Status:
UNKNOWN
Last Update Posted:
2023-01-13
First Post:
2022-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Invasive and Clinical Features in Patients With Brugada Syndrome Undergoing Catheter Ablation
Sponsor:
University of Sao Paulo General Hospital
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: