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Epicardial Ablation in Brugada Syndrome (BRUGADA_I)

Primary Purpose

Brugada Syndrome

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
mapping/ablation
Ajmaline
ablation
mapping
Sponsored by
IRCCS Policlinico S. Donato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brugada Syndrome focused on measuring radiofrequency ablation, mapping, sudden death, syncope

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • IRCCS Policlinico S. Donato

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mapping/ablation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Absence of episodes of ventricular arrhythmias
Absence of ECG Br pattern and arrhythmic episodes as documented by ICD interrogation, particularly in patients with worst clinical presentation and frequent ICD discharges
Absence of episodes of ventricular arrhythmias
Absence of ECG BR pattern and arrhythmic episodes as documented by ICD particularly in patients with worst clinical presentation and frequent ICD discharges.
Absence of episodes of ventricular arrhythmias
Absence of ECG Br pattern and arrhythmic episodes will be evaluated clinically as documented by ICD particularly in patients with worst clinical presentation and frequent ICD discharges.
Complications
Acute complications during and after the procedure will be evaluated clinically. Potential pericardial damage will be evaluated clinically and by Echocardiography.
Long-term complications
Long-term complications will be evaluated 3 months after the procedure clinically and by echocardiography

Full Information

First Posted
November 11, 2015
Last Updated
January 13, 2018
Sponsor
IRCCS Policlinico S. Donato
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1. Study Identification

Unique Protocol Identification Number
NCT02641431
Brief Title
Epicardial Ablation in Brugada Syndrome
Acronym
BRUGADA_I
Official Title
Electrical Substrate Elimination in Brugada Syndrome. Results in 135 Consecutive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 16, 2015 (Actual)
Primary Completion Date
December 21, 2016 (Actual)
Study Completion Date
December 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Donato

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The present Registry is designed as a prospective, monocentric study. All patients referred to the Arrhythmology Department of IRCCS Policlinico San Donato Milanese, University- Hospital, for the management of BrS and fulfilling the selection criteria will be invited to participate in the study and will be asked their written consent to the participation in the trial. Mapping and RFA procedure will be performed following a standardized procedure in hospital settings. Patients will be monitored for at least 3 days after procedure. Before hospital discharge, echocardiography and 12-lead ECG will be performed in all patients. An ajmaline test will be systematically performed after the procedure and thereafter at 3, 6, and 12 months after ablation. Patients will be followed up clinically after procedure as per normal clinical practice. Follow-up visits will be scheduled at 3, 6, and 12 months. 12-lead ECG and ICD interrogation will be performed at each follow-up visits. Patients will be instructed to immediately contact the center in case of symptoms suggestive of ventricular arrhythmias. Documentation for intercurrent events will be requested and collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brugada Syndrome
Keywords
radiofrequency ablation, mapping, sudden death, syncope

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mapping/ablation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
mapping/ablation
Other Intervention Name(s)
voltage, activation and duration maps
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ajmaline
Other Intervention Name(s)
Pharmacological testing
Intervention Description
Epicardial mapping will be performed before and after ajmaline (1mg/Kg in 5 minutes).
Intervention Type
Procedure
Intervention Name(s)
ablation
Other Intervention Name(s)
RFA
Intervention Description
Radiofrequency will be delivered on areas of the abnormal electrograms using an externally irrigated 3.5-mm tip ablation catheter.
Intervention Type
Procedure
Intervention Name(s)
mapping
Intervention Description
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.
Primary Outcome Measure Information:
Title
Absence of the ECG Br pattern
Description
Disappearance of the BrS-ECG pattern before and after ajmaline immediately after epicardial ablation and at discharge.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Absence of episodes of ventricular arrhythmias
Description
Absence of ECG Br pattern and arrhythmic episodes as documented by ICD interrogation, particularly in patients with worst clinical presentation and frequent ICD discharges
Time Frame
3 months after procedure
Title
Absence of episodes of ventricular arrhythmias
Description
Absence of ECG BR pattern and arrhythmic episodes as documented by ICD particularly in patients with worst clinical presentation and frequent ICD discharges.
Time Frame
6 months after procedure
Title
Absence of episodes of ventricular arrhythmias
Description
Absence of ECG Br pattern and arrhythmic episodes will be evaluated clinically as documented by ICD particularly in patients with worst clinical presentation and frequent ICD discharges.
Time Frame
12 months after procedure
Title
Complications
Description
Acute complications during and after the procedure will be evaluated clinically. Potential pericardial damage will be evaluated clinically and by Echocardiography.
Time Frame
1 day
Title
Long-term complications
Description
Long-term complications will be evaluated 3 months after the procedure clinically and by echocardiography
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Pregnancy or breast-feeding Patients with low arrhythmic risk (Brugada pattern III) Life expectancy < 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Pappone, MD
Organizational Affiliation
IRCCS Policlinico S. Donato
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Policlinico S. Donato
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
1309182
Citation
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.
Results Reference
result
PubMed Identifier
26291334
Citation
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.
Results Reference
result
PubMed Identifier
21403098
Citation
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.
Results Reference
result
PubMed Identifier
31647530
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.
Results Reference
derived
PubMed Identifier
29650119
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.
Results Reference
derived
PubMed Identifier
28500178
Citation
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.
Results Reference
derived

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Epicardial Ablation in Brugada Syndrome

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