UnknownNot Applicable

Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death

Italy150 participantsStarted 2017-09-10

Plain-language summary

A total of 150 patients will be randomized to perform catheter ablation or not in a 2:1 fashion in selected patients with Brugada-related symptoms (Ablation+ICD arm 105 patients vs ICD only 45 patients).

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Survival from any VA recurrence will be considered as primary endpoint

Timeframe: 2 years after ablation

Trial details

NCT IDNCT03294278

SponsorIRCCS Policlinico S. Donato

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-28

Contact for this trial

Carlo Pappone, MD

+39 02 52774260 carlo.pappone@af-ablation.org

View on ClinicalTrials.gov More Ventricular Arrhythmias and Cardiac Arrest trials