Epicardial ablation for patients with Brugada syndrome
Epicardial Ablation in 500 Consecutive Brugada Syndrome Patients
This study is testing if a procedure called epicardial ablation can help people with Brugada syndrome by improving their heart rhythms and preventing dangerous heart issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milano) |
| Trial ID | NCT03106701 on ClinicalTrials.gov |
What this trial studies
This study is an extension of previous research focusing on the effects of epicardial ablation in patients with Brugada syndrome (BrS). It aims to enroll a total of 500 patients who have undergone ICD implantation, assessing the acute and long-term benefits of the procedure. The methodology includes advanced echocardiography and electroanatomical mapping to identify and eliminate arrhythmogenic substrates, with follow-up assessments over a decade. The primary goal is to normalize ECG patterns and prevent ventricular tachycardia or fibrillation.
Who should consider this trial
Good fit: Ideal candidates are symptomatic BrS patients with a history of cardiac arrest, syncope, or other related symptoms who have received an ICD.
Not a fit: Patients under 18 years old, those with prior epicardial ablation, or significant co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of life-threatening arrhythmias in patients with Brugada syndrome.
How similar studies have performed: Previous studies have shown promising results with epicardial ablation in Brugada syndrome, indicating potential for success in this extension study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptomatic BrS patients with typical BrS-related symptoms (cardiac arrest or syncope) or without typical BrS-related symptoms (dizziness, palpitations, presyncope, dyspnea) ICD implantation, spontaneous or ajmaline-induced type 1 Br pattern. Exclusion Criteria: * Age \< 18 years, prior epicardial ablation, pregnancy, co-morbidities.
Where this trial is running
San Donato Milanese, Milano
- IRCCS Policlinico S. Donato — San Donato Milanese, Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Carlo Pappone, MD — IRCCS Policlinico San Donato, Milan
- Study coordinator: Carlo Pappone, MD
- Email: carlo.pappone@af-ablation.org
- Phone: +39 02 52774260
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.