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Brugada SyndromeBRUGADA_INCT02641431

Epicardial Ablation in Brugada Syndrome

A study testing mapping/ablation, Ajmaline and ablation in people with Brugada Syndrome, run by IRCCS Policlinico S. Donato at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brugada Syndrome
What is being tested?
mapping/ablation, Ajmaline and ablation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
1 siteItaly
Study dates
16 Nov 2015to 30 Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS Policlinico S. Donato

    San Donato Milanese, Milano, 20097

Other trials in Italy

About this study

Official title: Electrical Substrate Elimination in Brugada Syndrome. Results in 135 Consecutive Patients

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.

Read the 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.

Being tested
mapping/ablation, Ajmaline, ablation, mapping
Keywords
radiofrequency ablation, mapping, sudden death, syncope
Medical subject headings
Brugada Syndrome, Death, Sudden, Syncope

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mapping/ablationProcedure or surgery

    Also called voltage, activation and duration maps

    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

  • AjmalineDrug

    Also called Pharmacological testing

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

  • ablationProcedure or surgery

    Also called RFA

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

  • mappingProcedure or surgery

    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.

Study groups in NCT02641431
Study groupRoleWhat they receive
mapping/ablationExperimentalEpicardial 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.
Receives: Procedure: mapping/ablation; Drug: Ajmaline; Procedure: ablation; Procedure: mapping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absence of the ECG Br pattern

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

    Measured: 1 day

Secondary outcomes (5)

  1. 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

    Measured: 3 months after procedure

  2. 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.

    Measured: 6 months after procedure

  3. 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.

    Measured: 12 months after procedure

  4. Complications

    Acute complications during and after the procedure will be evaluated clinically. Potential pericardial damage will be evaluated clinically and by Echocardiography.

    Measured: 1 day

  5. Long-term complications

    Long-term complications will be evaluated 3 months after the procedure clinically and by echocardiography

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2015 (estimated)
  2. Study start16 Nov 2015
  3. Primary completion21 Dec 2016
  4. Study completion30 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02641431
Sponsor's protocol ID
AR-01-2015
Acronym
BRUGADA_I
Status last verified
Nov 2017
First submitted
11 Nov 2015
Last updated
17 Jan 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 1309182

  • 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.

    PubMed 26291334

  • 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.

    PubMed 21403098

  • 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.

    PubMed 31647530

  • 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.

    PubMed 29650119

  • 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.

    PubMed 28500178

Questions about this trial

What is this clinical trial studying?

A study testing mapping/ablation, Ajmaline and ablation in people with Brugada Syndrome, run by IRCCS Policlinico S. Donato at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absence of the ECG Br pattern (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02641431, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.

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