Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death

San Donato Group (GSD)

Status: Enrolling

Conditions: Ventricular Arrhythmias and Cardiac Arrest

Treatments: Other: ablation plus ICD

Study type: Interventional

Funder types: Other

Identifiers

NCT03294278

IRCCSDonato Brugada-randomized

Details and patient eligibility

About

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).

Full 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).

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Ablation plus ICD

Active Comparator group

Description:

Epicardial ablation by radio-frequency

Treatment:

Other: ablation plus ICD

ICD alone

Active Comparator group

Description:

Implantation of ICD

Treatment:

Other: ablation plus ICD