Epicardial Ablation in Brugada Syndrome

NCT02641431 | Completed DMC

• 1 other identifier: AR-01-2015
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study evaluates the methodology and results of epicardial mapping/ablation in a large series of consecutive selected BrS patients and to verify if RFA could normalize the consequences of a genetic disease.

Conditions

Brugada Syndrome

Keywords

radiofrequency ablation; mapping; sudden death; syncope

Outcome Measures

Primary Outcomes (1)

• Absence of the ECG Br pattern

  Disappearance of the BrS-ECG pattern before and after ajmaline immediately after epicardial ablation and at discharge.

  1 day

Secondary Outcomes (5)

• Absence of episodes of ventricular arrhythmias

  3 months after procedure

• Absence of episodes of ventricular arrhythmias

  6 months after procedure

• Absence of episodes of ventricular arrhythmias

  12 months after procedure

• Complications

  1 day

• Long-term complications

  3 months

Study Arms (1)

mapping/ablation

EXPERIMENTAL

Epicardial substrate identification consisted in mapping the entire RV epicardial surface under baseline conditions and after ajmaline infusion (1mg/kg in 5 minutes).We obtained 3 groups of RV epicardial maps using CARTO3 system: 1) bipolar/unipolar voltage map, 2) local activation time map (LAT), and 3) potential duration map (PDM), in which abnormal long-duration bipolar electrograms were defined as low-frequency (up to 100 Hz) prolonged duration (\> 200 ms) bipolar signals with delayed activity extending beyond the end of the QRS complex. Epicardial ablation was performed during sinus rhythm using a stepwise strategy in a descending order of abnormal potential duration as displayed on the map and beginning from the longest potentials.

Procedure: mapping/ablation; Drug: Ajmaline; Procedure: ablation; Procedure: mapping

Interventions

mapping/ablation PROCEDURE

Mapping/ablation procedures will be performed under general anesthesia. After femoral venous access and percutaneous epicardial access, a multipolar catheter will be positioned at the right ventricle apex. High-density endocardial and epicardial electroanatomical maps will be performed using the CARTO3 system to define areas of delayed fragmented prolonged potentials during stable sinus rhythm and during spontaneous or ajmaline-induced type 1 BrS ECG pattern. Ajmaline (1mg/Kg in 5 minutes) will be used for the provocative test. Complete endo and epicardial maps will be obtained to ensure reconstruction of a 3-dimensional geometry of the cardiac chambers and to identify areas of abnormal electrograms as characterized by prolonged fragmented ventricular signals

Also known as: voltage, activation and duration maps

mapping/ablation

Ajmaline DRUG

Epicardial mapping will be performed before and after ajmaline (1mg/Kg in 5 minutes).

Also known as: Pharmacological testing

mapping/ablation

ablation PROCEDURE

Radiofrequency will be delivered on areas of the abnormal electrograms using an externally irrigated 3.5-mm tip ablation catheter.

Also known as: RFA

mapping/ablation

mapping PROCEDURE

A re-map focusing on the targeted area will be obtained after ablation. Re-mapping and ajmaline reinfusion will be used to confirm the elimination of all the abnormal electrogram and BrS-ECG pattern disappearance.

mapping/ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients affected by Brugada Syndrome, profiled by genetic testing, with documented spontaneous or drug-induced type I BrS ECG pattern, with symptoms attributable to ventricular arrhythmias and presenting multiple documented arrhythmic episodes
• Patients with an ICD already implanted
• Patients referred to the center for an electrophysiological study and indication to a potential concomitant radio-frequency catheter ablation (RFA) of ventricular arrhythmia or ventricular fibrillation
• Age ≥ 18
• Willingness to attend follow-up examinations
• Written informed consent to the participation in the trial

You may not qualify if:

• Pregnancy or breast-feeding
• Patients with low arrhythmic risk (Brugada pattern III)
• Life expectancy \< 12 months.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico S. Donato

San Donato Milanese, Milano, 20097, Italy

Location

Related Publications (6)

• Brugada P, Brugada J. Right bundle branch block, persistent ST segment elevation and sudden cardiac death: a distinct clinical and electrocardiographic syndrome. A multicenter report. J Am Coll Cardiol. 1992 Nov 15;20(6):1391-6. doi: 10.1016/0735-1097(92)90253-j.

  PMID: 1309182 RESULT

• Brugada J, Pappone C, Berruezo A, Vicedomini G, Manguso F, Ciconte G, Giannelli L, Santinelli V. Brugada Syndrome Phenotype Elimination by Epicardial Substrate Ablation. Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1373-81. doi: 10.1161/CIRCEP.115.003220. Epub 2015 Aug 19.

  PMID: 26291334 RESULT

• Nademanee K, Veerakul G, Chandanamattha P, Chaothawee L, Ariyachaipanich A, Jirasirirojanakorn K, Likittanasombat K, Bhuripanyo K, Ngarmukos T. Prevention of ventricular fibrillation episodes in Brugada syndrome by catheter ablation over the anterior right ventricular outflow tract epicardium. Circulation. 2011 Mar 29;123(12):1270-9. doi: 10.1161/CIRCULATIONAHA.110.972612. Epub 2011 Mar 14.

  PMID: 21403098 RESULT

• 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.

  PMID: 31647530 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.

  PMID: 29650119 DERIVED

• Pappone C, Brugada J, Vicedomini G, Ciconte G, Manguso F, Saviano M, Vitale R, Cuko A, Giannelli L, Calovic Z, Conti M, Pozzi P, Natalizia A, Crisa S, Borrelli V, Brugada R, Sarquella-Brugada G, Guazzi M, Frigiola A, Menicanti L, Santinelli V. Electrical Substrate Elimination in 135 Consecutive Patients With Brugada Syndrome. Circ Arrhythm Electrophysiol. 2017 May;10(5):e005053. doi: 10.1161/CIRCEP.117.005053.

  PMID: 28500178 DERIVED

MeSH Terms

Conditions

Brugada Syndrome; Death, Sudden; Syncope

Interventions

Ajmaline

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Carlo Pappone, MD

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: December 29, 2015
• Study Start: November 16, 2015
• Primary Completion: December 21, 2016
• Study Completion: December 30, 2016
• Last Updated: January 17, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)