ECG Brugada Pattern
Conditions
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 500 consecutive BrS patients.
Detailed 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.
Interventions
PROCEDUREAblation
Epicardial Radiofrequency ablation
Sponsors
IRCCS Policlinico S. Donato
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic BrS patients with typical BrS-related symptoms (cardiac arrest or syncope) or without typical BrS-related symptoms (dizziness, palpitations, presyncope, dyspnea) ICD implantation, spontaneous or ajmaline-induced type 1 Br pattern.
Exclusion criteria
* Age \< 18 years, prior epicardial ablation, pregnancy, co-morbidities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type 1 BrS-ECG pattern elimination by epicardial ablation before and after ajmaline test. | 1 day after ablation | Normalization of ECG pattern after elimination by radio-frequency ablation of all abnormal epicardial potentials |
| VT/VF inducibility | immediately after mapping and ablation | Programmed stimulation was achieved at twice the diastolic threshold and randomly performed at RV apex and RV outflow tract using up to 3 drive cycle lengths (from 600 to 350ms) and up to three extrastimuli (S2-S4) delivered from the apex and outflow tract of the right ventricle. |
| Absence of VT/VF | 1,3,6,12,18,24,36,48,60,72,84,96,108,120 months after ablation | Absence of VT/VF by ICD interrogation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absence of VA episodes | 6 months | ICD interrogation |
| Absence of Br Pattern and RV mechanical abnormalities using echo and cardiac deformation analysis before and after ajmaline test | 3 months | Abolition of typical BrS-ECG pattern and RV mechanical abnormalities before and after ajmaline. |
| Absence of Br ECG pattern after ajmaline test | 24 months | Normalization of 12-lead ECG recording at baseline and after ajmaline test |
| Absence of VA episodes at EP study | 3 months | Non-inducibility of VT/VT at programmed electrophysiological study |
| Absence of Br Pattern at ajmaline test | 6 months | Normalization of 12-lead ECG recording and echo parameters at baseline and after ajmaline test |
Countries
Italy
Contacts
Primary ContactCarlo Pappone, MD
Outcome results
None listed