Epicardial Ablation in Brugada Syndrome. An Extension Study of 500 BrS.Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ablation Radiofrequency epicardial ablation |
Procedure: Ablation
Epicardial Radiofrequency ablation
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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
- Absence of VA episodes [6 months]
ICD interrogation
- Absence of VA episodes [12 months]
ICD interrogation and ajmaline test
- Absence of Br Pattern at ajmaline test [12 months]
Normalization of 12-lead ECG recording and echo parameters at baseline and after ajmaline test
- Absence of Br Pattern at ajmaline test [18 months]
Normalization of 12-lead ECG recording at baseline and after ajmaline test
- Absence of VA episodes [24 months]
ICD interrogation
- 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 [36 months]
ICD interrogation
- Absence of Br Pattern at ajmaline test [36 months]
Normalization of 12-lead ECG recording at baseline and after ajmaline test
- Absence of Br Pattern at ajmaline test [48 months]
Normalization of 12-lead ECG recording at baseline and after ajmaline test
- Absence of VA episodes at EP study [48 months up to 120 months]
ICD interrogation
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Policlinico S. Donato | San Donato Milanese | Milano | Italy | 20097 |
Sponsors and Collaborators
- IRCCS Policlinico S. Donato
Investigators
- Principal Investigator: Carlo Pappone, MD, IRCCS Policlinico San Donato, Milan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRCCSDonato