Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death

Launched by IRCCS POLICLINICO S. DONATO · Sep 26, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called epicardial ablation in patients with Brugada Syndrome, a condition that can lead to dangerous heart rhythms and sudden cardiac arrest. The goal of the trial is to see if this procedure can help prevent these serious heart issues. In the study, 150 participants will be randomly assigned to either receive the ablation procedure along with an implantable cardioverter-defibrillator (ICD) or to have only the ICD. The trial is open to adults aged 18 and older who have been diagnosed with Brugada Syndrome and have experienced at least one shock from their ICD due to dangerous heart rhythms.

To participate, candidates must meet specific criteria, such as having documented episodes of abnormal heart rhythms and being willing to attend follow-up appointments. Those who are pregnant, have serious health issues that limit their life expectancy, or cannot undergo general anesthesia will not be eligible. If you qualify and choose to participate, you can expect to be closely monitored throughout the trial and receive care to help manage your condition. This research is essential in understanding how to better prevent complications from Brugada Syndrome and improve patient outcomes.

Gender

ALL

Eligibility 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