NCT02641431: BRUGADA_I

Epicardial Ablation in Brugada Syndrome

Completed NA Last updated 17 January 2018

What this trial tests

NA trial testing mapping/ablation in Brugada Syndrome in 135 participants. Completed in 30 December 2016.

Timeline

16 November 2015

Primary endpoint
21 December 2016

30 December 2016

Quick facts

Lead sponsor	IRCCS Policlinico S. Donato
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	135
Start date	16 November 2015
Primary completion	21 December 2016
Estimated completion	30 December 2016
Sites	1 location across Italy

Drugs / interventions tested

• mapping/ablation
• Ajmaline (AJMALINE) — full drug profile →
• ablation
• mapping

Conditions studied

• Brugada Syndrome — all drugs for Brugada Syndrome →

Sponsor

IRCCS Policlinico S. Donato

Who can join

18 and older, any sex, with Brugada Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Electrical Substrate Elimination in 135 Consecutive Patients With Brugada Syndrome.
   Pappone C, Brugada J, Vicedomini G, Ciconte G, et al · · 2017 · cited 183× · PMID 28500178 · DOI 10.1161/circep.117.005053
2. Brugada syndrome genetics is associated with phenotype severity.
   Ciconte G, Monasky MM, Santinelli V, Micaglio E, et al · · 2021 · cited 83× · PMID 33221895 · DOI 10.1093/eurheartj/ehaa942
3. Assessing the Malignant Ventricular Arrhythmic Substrate in Patients With Brugada Syndrome.
   Pappone C, Ciconte G, Manguso F, Vicedomini G, et al · · 2018 · cited 68× · PMID 29650119 · DOI 10.1016/j.jacc.2018.02.022
4. Non-invasive assessment of the arrhythmogenic substrate in Brugada syndrome using signal-averaged electrocardiogram: clinical implications from a prospective clinical trial.
   Ciconte G, Santinelli V, Vicedomini G, Borrelli V, et al · · 2019 · cited 21× · PMID 31647530 · DOI 10.1093/europace/euz295
5. Risk Stratification in Brugada Syndrome: Current Status and Emerging Approaches.
   Honarbakhsh S, Providencia R, Lambiase PD. · · 2018 · cited 18× · PMID 29967678 · DOI 10.15420/aer.2018.2.2
6. Challenges in Brugada Syndrome Stratification: Investigating <i>SCN5A</i> Mutation Localization and Clinical Phenotypes.
   Tarantino A, Ciconte G, Ghiroldi A, Mastrocinque F, et al · · 2023 · cited 4× · PMID 38068978 · DOI 10.3390/ijms242316658
7. Electrocardiographic temporo-spatial assessment of depolarization and repolarization changes after epicardial arrhythmogenic substrate ablation in Brugada syndrome.
   Locati ET, Van Dam PM, Ciconte G, Heilbron F, et al · · 2023 · cited 1× · PMID 38045442 · DOI 10.1093/ehjdh/ztad050