Clinical Trial: Epicardial Ablation in Brugada Syndrome. An Extension Study of 200 BrS.Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Epicardial Ablation in 200 Consecutive Brugada Syndrome Patients

Brief Summary: This study represents an extension of a previous study (NCT02641431) on the acute and long-term benefit of epicardial ablation on elimination of both BrS-ECG pattern and VT/VF inducibility in 200 consecutive BrS patients.

Detailed Summary: According to previous protocol (NCT02641431), additional consecutive selected patients having an ICD implantation will be enrolled up to a total of 200 BrS patients. Three-dimensional color-coded voltage, activation and duration electroanatomical maps before and after ajmaline (1mg/kg in 5 minutes) wiil determine the site and the size of the arrhythmogenic substrate as characterized by abnormally prolonged fragmented ventricular potentials. Primary endpoint will be identification and elimination of this electrophysiological substrate by RF applications leading to ECG pattern normalization and VT/VF non-inducibility before and after ajmaline. Patients will be followed up to 48 months after ablation by sequential 12-lead ECG and Holter recording, ICD interrogation, VT/VF inducibility before and after ajmaline test.
Sponsor: IRCCS Policlinico S. Donato

Current Primary Outcome: Type 1 BrS-ECG pattern elimination by epicardial ablation before and after ajmaline test. [ Time Frame: 1 day after ablation ]

Normalization of ECG pattern after elimination by radio-frequency ablation of all abnormal epicardial potentials


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Absence of Br Pattern at ajmaline test [ Time Frame: 3 months ]
    Abolition of all abnormal epicardial electrograms before and after ajmaline.
  • Absence of VA episodes at EP study [ Time Frame: 3 months ]
    Non-inducibility of VT/VT at programmed electrophysiological study
  • Absence of Br Pattern at ajmaline test [ Time Frame: 6 months ]
    Normalization of 12-lead ECG recording at baseline and after ajmaline test
  • Absence of VA episodes [ Time Frame: 6 months ]
    ICD interrogation
  • Absence of VA episodes [ Time Frame: 12 months ]
    ICD interrogation and ajmaline test
  • Absence of Br Pattern at ajmaline test [ Time Frame: 12 months ]
    Normalization of 12-lead ECG recording at baseline and after ajmaline test
  • Absence of Br Pattern at ajmaline test [ Time Frame: 18 months ]
    Normalization of 12-lead ECG recording at baseline and after ajmaline test
  • Absence of VA episodes [ Time Frame: 24 months ]
    ICD interrogation
  • Absence of Br ECG pattern after ajmaline test [ Time Frame: 24 months ]
    Normalization of 12-lead ECG recording at baseline and after ajmaline test
  • Absence of VA episodes at EP study [ Time Frame: 36 months ]
    ICD interrogation
  • Absence of Br Pattern at ajmaline test [ Time Frame: 36 months ]
    Normalization of 12-lead ECG recording at baseline and after ajmaline test
  • Absence of Br Pattern at ajmaline test [ Time Frame: 48 months ]
    Normalization of 12-lead ECG recording at baseline and after ajmaline test
  • Absence of VA episodes at EP study [ Time Frame: 48 months ]
    ICD interrogation


Original Secondary Outcome: Same as current

Information By: IRCCS Policlinico S. Donato

Dates:
Date Received: March 14, 2017
Date Started: March 14, 2017
Date Completion: March 14, 2019
Last Updated: April 10, 2017
Last Verified: April 2017