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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation | Experimental | Radiofrequency epicardial ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation | Procedure | Epicardial Radiofrequency ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Type 1 BrS-ECG pattern elimination by epicardial ablation before and after ajmaline test. | Normalization of ECG pattern after elimination by radio-frequency ablation of all abnormal epicardial potentials | 1 day after ablation |
| VT/VF inducibility | 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. | immediately after mapping and ablation |
| Absence of VT/VF | Absence of VT/VF by ICD interrogation | 1,3,6,12,18,24,36,48,60,72,84,96,108,120 months after ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Br Pattern and RV mechanical abnormalities using echo and cardiac deformation analysis before and after ajmaline test | Abolition of typical BrS-ECG pattern and RV mechanical abnormalities before and after ajmaline. | 3 months |
| Absence of VA episodes at EP study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlo Pappone, MD | Contact | +39 02 52774260 | carlo.pappone@af-ablation.org |
| Name | Affiliation | Role |
|---|---|---|
| Carlo Pappone, MD | IRCCS Policlinico San Donato, Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico S. Donato | Recruiting | San Donato Milanese | Milano | 20097 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31647530 | Derived | Ciconte G, Santinelli V, Vicedomini G, Borrelli V, Monasky MM, Micaglio E, Giannelli L, Negro G, Giordano F, Mecarocci V, Mazza BC, Locati E, Anastasia L, Calovic Z, Pappone C. Non-invasive assessment of the arrhythmogenic substrate in Brugada syndrome using signal-averaged electrocardiogram: clinical implications from a prospective clinical trial. Europace. 2019 Dec 1;21(12):1900-1910. doi: 10.1093/europace/euz295. | |
| 30067493 |
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| ID | Term |
|---|---|
| D053840 | Brugada Syndrome |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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Non-inducibility of VT/VT at programmed electrophysiological study |
| 3 months |
| Absence of Br Pattern at ajmaline test | Normalization of 12-lead ECG recording and echo parameters at baseline and after ajmaline test | 6 months |
| Absence of VA episodes | ICD interrogation | 6 months |
| Absence of VA episodes | ICD interrogation and ajmaline test | 12 months |
| Absence of Br Pattern at ajmaline test | Normalization of 12-lead ECG recording and echo parameters at baseline and after ajmaline test | 12 months |
| Absence of Br Pattern at ajmaline test | Normalization of 12-lead ECG recording at baseline and after ajmaline test | 18 months |
| Absence of VA episodes | ICD interrogation | 24 months |
| Absence of Br ECG pattern after ajmaline test | Normalization of 12-lead ECG recording at baseline and after ajmaline test | 24 months |
| Absence of VA episodes at EP study | ICD interrogation | 36 months |
| Absence of Br Pattern at ajmaline test | Normalization of 12-lead ECG recording at baseline and after ajmaline test | 36 months |
| Absence of Br Pattern at ajmaline test | Normalization of 12-lead ECG recording at baseline and after ajmaline test | 48 months |
| Absence of VA episodes at EP study | ICD interrogation | 48 months up to 120 months |
| Derived |
| Ciconte G, Santinelli V, Brugada J, Vicedomini G, Conti M, Monasky MM, Borrelli V, Castracane W, Aloisio T, Giannelli L, Di Dedda U, Pozzi P, Ranucci M, Pappone C. General Anesthesia Attenuates Brugada Syndrome Phenotype Expression: Clinical Implications From a Prospective Clinical Trial. JACC Clin Electrophysiol. 2018 Apr;4(4):518-530. doi: 10.1016/j.jacep.2017.11.013. Epub 2018 Feb 13. |
| 29650119 | Derived | Pappone C, Ciconte G, Manguso F, Vicedomini G, Mecarocci V, Conti M, Giannelli L, Pozzi P, Borrelli V, Menicanti L, Calovic Z, Della Ratta G, Brugada J, Santinelli V. Assessing the Malignant Ventricular Arrhythmic Substrate in Patients With Brugada Syndrome. J Am Coll Cardiol. 2018 Apr 17;71(15):1631-1646. doi: 10.1016/j.jacc.2018.02.022. |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |