Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death

Not Applicable

Recruiting

• Conditions: Ventricular Arrhythmias and Cardiac Arrest
• Interventions: Other: ablation plus ICD

• Registration Number: NCT03294278
• Lead Sponsor: IRCCS Policlinico S. Donato

Brief 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).

Detailed Description

The main purpose of this trial is to develop evidence-based curative treatment with optimal net benefit for patients with Brugada syndrome. As recent non-randomized pilot studies and scarce case reports documented the potential benefit of epicardial ablation, patients in this trial will be randomized to epicardial catheter ablation of the regions exhibiting abnormally prolonged and fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (ablation arm) or continued implanted cardioverter defibrillator therapy (control arm).

Survival from any ventricular arrhythmia (VA) recurrence will be considered as primary endpoint.

A projected 150 patients will be enrolled and randomized to receive ablation or not in a 2:1 fashion (Ablation+ICD arm 105 patients vs ICD only 45 patients).

Study Timeline

• Study Start: 2017-09-10
• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-27
• Status Verified: 2023-09
• Primary Completion: 2023-09-28
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ablation plus ICD	ablation plus ICD	Epicardial ablation by radio-frequency
ICD alone	ablation plus ICD	Implantation of ICD

Primary Outcome Measures

Name	Time	Method
Survival from any VA recurrence will be considered as primary endpoint	2 years after ablation	NO ventricular arrhythmia recurrence

Trial Locations

Locations (1)

IRCCS Policlinico S. Donato; 🇮🇹 San Donato Milanese, Milano, Italy