Clinical trial NCT03106701: Epicardial Ablation in Brugada Syndrome. An Extension Study of 500 BrS.Patients
Official title: Epicardial Ablation in 500 Consecutive Brugada Syndrome Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ECG Brugada Pattern
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Type 1 BrS-ECG pattern elimination by epicardial ablation before and after ajmaline test.
timeFrame: 1 day after ablation
measure: VT/VF inducibility
timeFrame: immediately after mapping and ablation
measure: Absence of VT/VF
timeFrame: 1,3,6,12,18,24,36,48,60,72,84,96,108,120 months after ablation
Secondary outcomes:
measure: Absence of Br Pattern and RV mechanical abnormalities using echo and cardiac deformation analysis before and after ajmaline test
timeFrame: 3 months
measure: Absence of VA episodes at EP study
timeFrame: 3 months
measure: Absence of Br Pattern at ajmaline test
timeFrame: 6 months
measure: Absence of VA episodes
timeFrame: 6 months
measure: Absence of VA episodes
timeFrame: 12 months
measure: Absence of Br Pattern at ajmaline test
timeFrame: 12 months
measure: Absence of Br Pattern at ajmaline test
timeFrame: 18 months
measure: Absence of VA episodes
timeFrame: 24 months
measure: Absence of Br ECG pattern after ajmaline test
timeFrame: 24 months
measure: Absence of VA episodes at EP study
timeFrame: 36 months
measure: Absence of Br Pattern at ajmaline test
timeFrame: 36 months
measure: Absence of Br Pattern at ajmaline test
timeFrame: 48 months
measure: Absence of VA episodes at EP study
timeFrame: 48 months up to 120 months
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico S. Donato
state: Milano
Study officials:
affiliation: IRCCS Policlinico San Donato, Milan
name: Carlo Pappone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.