Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death

  • STATUS
    Recruiting
  • End date
    Dec 27, 2022
  • participants needed
    150
  • sponsor
    IRCCS Policlinico S. Donato
Updated on 27 May 2021

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).

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).

Details
Condition Ventricular Arrhythmias and Cardiac Arrest
Treatment ablation plus ICD
Clinical Study IdentifierNCT03294278
SponsorIRCCS Policlinico S. Donato
Last Modified on27 May 2021

Eligibility

Yes No Not Sure

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

Pregnancy or breast-feeding (which would exclude an ablation procedure)
Contraindications to general anesthesia or epicardial ablation
Life expectancy < 12 months
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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