Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death

NCT03294278 — Not applicable, Unknown, 150 participants, IRCCS Policlinico S. Donato

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Epicardial Ablation in Brugada Syndrome in the Prevention of Sudden Cardiac Death. A Randomized Prospective Follow-up Study.

Registry	NCT03294278
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	150 (Estimated)
Sponsor	IRCCS Policlinico S. Donato (Other)
Conditions	Ventricular Arrhythmias and Cardiac Arrest
Interventions	ablation plus ICD (Other)
Dates	start 2017-09-10, primary completion 2023-09-28 (estimated), completion 2023-12-30 (estimated), first posted 2017-09-27, last updated 2023-09-29
Locations	1 site in Italy

-Summary

A total of 150 patients will be randomized to perform catheter ablation or not in a 2:1 fashion in selected patients with Brugada-related symptoms (Ablation+ICD arm 105 patients vs ICD only 45 patients).

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+Detailed description

The main purpose of this trial is to develop evidence-based curative treatment with optimal net benefit for patients with Brugada syndrome. As recent non-randomized pilot studies and scarce case reports documented the potential benefit of epicardial ablation, patients in this trial will be randomized to epicardial catheter ablation of the regions exhibiting abnormally prolonged and fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (ablation arm) or continued implanted cardioverter defibrillator therapy (control arm).

Survival from any ventricular arrhythmia (VA) recurrence will be considered as primary endpoint.

A projected 150 patients will be enrolled and randomized to receive ablation or not in a 2:1 fashion (Ablation+ICD arm 105 patients vs ICD only 45 patients).

+Arms and interventions

Arm	Type	Interventions	Description
Ablation plus ICD	Active comparator	Other: ablation plus ICD	Epicardial ablation by radio-frequency
ICD alone	Active comparator	Other: ablation plus ICD	Implantation of ICD

ablation plus ICD (Other): Defibrillator, radio-frequency catheter ablation

+Outcome measures

Primary outcomes

Survival from any VA recurrence will be considered as primary endpoint [2 years after ablation]: NO ventricular arrhythmia recurrence

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

* Patients affected by Brugada Syndrome diagnosed according to 2013 HRS/EHRA/APHRS
* Consensus document criteria
* The patient received at least 1 appropriate ICD shock.
* Documentation of any previous ventricular arrhythmia (VA) in the form of VT, non-sustained VT, non-sustained VF, RVOT PVC with a daily burden >10000;
* Age ≥ 18;
* Willingness to attend follow-up examinations;
* Written informed consent for participation in the trial.

Exclusion Criteria:

* A patient who does not meet inclusion criteria;
* Pregnancy or breast-feeding (which would exclude an ablation procedure);
* Contraindications to general anesthesia or epicardial ablation;
* Life expectancy < 12 months

+Locations (1)

Facility	City	Country	Status
IRCCS Policlinico S. Donato	San Donato Milanese, Milano	Italy	Recruiting

+Publications

Results publication: Pappone C, Ciconte G, Vicedomini G, Micaglio E, Boccellino A, Negro G, Giannelli L, Rondine R, Creo P, Tarantino A, Ballarotto M, Maiolo V, Ciaccio C, Manuello R, Locati ET, Mazza BC, Vecchi M, Calovic Z, Anastasia L. Epicardial ablation in high-risk Brugada syndrome to prevent ventricular fibrillation: results from a randomized clinical trial. Europace. 2025 May 7;27(5):euaf097. doi: 10.1093/europace/euaf097. PMID 40401314

+Investigators

Carlo Pappone, MD, Principal investigator, IRCCS Policlinico San Donato Milan, Italy

My Notes

Public

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