Investigating the effects of catheter ablation in patients with Brugada syndrome
Invasive and Clinical Features in Patients With Brugada Syndrome Undergoing Catheter Ablation: a Prospective, Single-centre, Randomized, Sham-controlled, and Masked Pilot Study
This study is testing whether a heart procedure called catheter ablation can improve the health of people with Brugada syndrome compared to those who don't receive the treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT05685134 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on understanding the electrophysiological and clinical impacts of radiofrequency catheter ablation in patients diagnosed with Brugada syndrome. It aims to compare the outcomes of patients undergoing ablation versus a control group over a one-year follow-up period. The study will assess immediate effects on cardiac electrophysiology and explore the relationship between invasive and clinical features of the condition. A total of 20 patients will be randomized into either the ablation or control group for this prospective, single-centre, randomized, sham-controlled pilot study.
Who should consider this trial
Good fit: Ideal candidates include patients with a type 1 Brugada ECG pattern who are clinically stable and able to commit to follow-up visits.
Not a fit: Patients with structural heart disease or those who have previously undergone right ventricular outflow tract ablation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into a potentially curative treatment for patients with Brugada syndrome, improving their long-term outcomes.
How similar studies have performed: While catheter ablation has shown promise in treating arrhythmias, this specific approach in Brugada syndrome is still being explored and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
São Paulo
- Instituto do Coração - InCor - HC/FMUSP — São Paulo, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.