Ablation treatment for patients with Brugada syndrome to prevent sudden death
Epicardial Ablation in Brugada Syndrome in the Prevention of Sudden Cardiac Death. A Randomized Prospective Follow-up Study.
This study is testing if a new heart procedure called ablation can help people with Brugada syndrome who have had dangerous heart rhythms live longer and healthier when combined with a heart device.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (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 | NCT03294278 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of epicardial catheter ablation in patients with Brugada syndrome who have experienced ventricular arrhythmias. A total of 150 patients will be randomized in a 2:1 ratio to receive either ablation combined with implanted cardioverter defibrillator (ICD) therapy or ICD therapy alone. The primary endpoint is survival from any recurrence of ventricular arrhythmia. The study seeks to provide evidence-based treatment options to improve patient outcomes in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with Brugada syndrome who have experienced at least one appropriate ICD shock and have documented ventricular arrhythmias.
Not a fit: Patients who are pregnant, have contraindications to anesthesia or ablation, or have a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of sudden cardiac death in patients with Brugada syndrome.
How similar studies have performed: Previous non-randomized pilot studies have suggested potential benefits of epicardial ablation, but this trial represents a more rigorous randomized approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients affected by Brugada Syndrome diagnosed according to 2013 HRS/EHRA/APHRS * Consensus document criteria * The patient received at least 1 appropriate ICD shock. * Documentation of any previous ventricular arrhythmia (VA) in the form of VT, non-sustained VT, non-sustained VF, RVOT PVC with a daily burden \>10000; * Age ≥ 18; * Willingness to attend follow-up examinations; * Written informed consent for participation in the trial. Exclusion Criteria: * A patient who does not meet inclusion criteria; * Pregnancy or breast-feeding (which would exclude an ablation procedure); * Contraindications to general anesthesia or epicardial ablation; * Life expectancy \< 12 months
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, Italy
- 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.