Epicardial Ablation in Brugada Syndrome. An Extension Study of 500 BrS.Patients
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- STATUS
- Recruiting
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- End date
- Jun 30, 2023
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- participants needed
- 300
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- sponsor
- IRCCS Policlinico S. Donato
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 500 consecutive BrS patients.
Description
According to previous protocol (NCT02641431), 300 additional consecutive selected patients having an ICD implantation will be enrolled up to a total of 500 BrS patients. Echocardiography with cardiac deformation analysis, 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 and potential wall motion abnormalities. 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 10 years after ablation by sequential 12-lead ECG and Holter recording, Echocardiography, ICD interrogation, VT/VF inducibility patterns before and after ajmaline test.
Details
| Condition | ECG Brugada Pattern |
|---|---|
| Treatment | ablation |
| Clinical Study Identifier | NCT03106701 |
| Sponsor | IRCCS Policlinico S. Donato |
| Last Modified on | 25 February 2022 |
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