Clinical Trial: Epicardial Ablation in Brugada Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Electrical Substrate Elimination in Brugada Syndrome. Results in 135 Consecutive Patients

Brief Summary: This prospective study evaluates the methodology and results of epicardial mapping/ablation in a large series of consecutive selected BrS patients and to verify if RFA could normalize the consequences of a genetic disease.

Detailed Summary:

The present Registry is designed as a prospective, monocentric study. All patients referred to the Arrhythmology Department of IRCCS Policlinico San Donato Milanese, University- Hospital, for the management of BrS and fulfilling the selection criteria will be invited to participate in the study and will be asked their written consent to the participation in the trial.

Mapping and RFA procedure will be performed following a standardized procedure in hospital settings. Patients will be monitored for at least 3 days after procedure.

Before hospital discharge, echocardiography and 12-lead ECG will be performed in all patients. An ajmaline test will be systematically performed after the procedure and thereafter at 3, 6, and 12 months after ablation.

Patients will be followed up clinically after procedure as per normal clinical practice. Follow-up visits will be scheduled at 3, 6, and 12 months. 12-lead ECG and ICD interrogation will be performed at each follow-up visits. Patients will be instructed to immediately contact the center in case of symptoms suggestive of ventricular arrhythmias. Documentation for intercurrent events will be requested and collected.


Sponsor: IRCCS Policlinico S. Donato

Current Primary Outcome: Absence of the ECG Br pattern [ Time Frame: 1 day ]

Disappearance of the BrS-ECG pattern before and after ajmaline immediately after epicardial ablation and at discharge.


Original Primary Outcome: Absence of the ECG Br pattern [ Time Frame: Day 1, after procedure ]

the disappearance of the ECG Br pattern both spontaneously and under drug test after radiofrequency ablation.


Current Secondary Outcome:

  • Absence of episodes of ventricular arrhythmias [ Time Frame: 3 months after procedure ]
    Absence of ECG Br pattern and arrhythmic episodes as documented by ICD interrogation, particularly in patients with worst clinical presentation and frequent ICD discharges
  • Absence of episodes of ventricular arrhythmias [ Time Frame: 6 months after procedure ]
    Absence of ECG BR pattern and arrhythmic episodes as documented by ICD particularly in patients with worst clinical presentation and frequent ICD discharges.
  • Absence of episodes of ventricular arrhythmias [ Time Frame: 12 months after procedure ]
    Absence of ECG Br pattern and arrhythmic episodes will be evaluated clinically as documented by ICD particularly in patients with worst clinical presentation and frequent ICD discharges.
  • Complications [ Time Frame: 1 day ]
    Acute complications during and after the procedure will be evaluated clinically. Potential pericardial damage will be evaluated clinically and by Echocardiography.
  • Long-term complications [ Time Frame: 3 months ]
    Long-term complications will be evaluated 3 months after the procedure clinically and by echocardiography


Original Secondary Outcome:

  • Absence of the type I-II Brugada ECG pattern at follow-up both spontaneously and under drug test [ Time Frame: Up to 24 months after procedure ]
  • Absence of episodes of ventricular arrhythmias [ Time Frame: 3 months after procedure ]
    Absence of arrhythmic episodes as documented by ICD interrogation
  • Absence of episodes of ventricular arrhythmias [ Time Frame: 6 months after procedure ]
    Absence of arrhythmic episodes as documented by ICD interrogation
  • Absence of episodes of ventricular arrhythmias [ Time Frame: 12 months after procedure ]
    Absence of arrhythmic episodes as documented by ICD interrogation
  • Absence of episodes of ventricular arrhythmias [ Time Frame: 18 months after procedure ]
    Absence of arrhythmic episodes as documented by ICD interrogation
  • Absence of episodes of ventricular arrhythmias [ Time Frame: 24 months after procedure ]
    Absence of arrhythmic episodes as documented by ICD interrogation
  • Absence of clinical symptoms indicative of ventricular arrhythmias [ Time Frame: up to 24 months afte procedure ]


Information By: IRCCS Policlinico S. Donato

Dates:
Date Received: November 11, 2015
Date Started: November 2015
Date Completion:
Last Updated: December 29, 2016
Last Verified: December 2016