Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death

NCT ID: NCT03294278

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-10
• Study Completion Date: 2023-12-30

Brief 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).

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).

Conditions

Ventricular Arrhythmias and Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ablation plus ICD

Epicardial ablation by radio-frequency

Group Type: ACTIVE_COMPARATOR

ablation plus ICD

Intervention Type: OTHER

Defibrillator, radio-frequency catheter ablation

ICD alone

Implantation of ICD

Group Type: ACTIVE_COMPARATOR

ablation plus ICD

Intervention Type: OTHER

Defibrillator, radio-frequency catheter ablation

Interventions

ablation plus ICD

Defibrillator, radio-frequency catheter ablation

Intervention Type: OTHER

Eligibility Criteria

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.

• Pregnancy or breast-feeding (which would exclude an ablation procedure);
• Contraindications to general anesthesia or epicardial ablation;
• Life expectancy < 12 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Policlinico S. Donato

OTHER

Sponsor Role: lead

Responsible Party

Carlo Pappone

Chief of Arrhythmology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlo Pappone, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Policlinico San Donato Milan, Italy

Locations

IRCCS Policlinico S. Donato

San Donato Milanese, Milano, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Carlo Pappone, MD

Role: CONTACT

carlo.pappone@af-ablation.org

+39 02 52774260

Facility Contacts

Carlo Pappone, MD, PhD

Role: primary

carlo.pappone@af-ablation.org

00390252774260

References

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.

Reference Type: DERIVED

PMID: 40401314 (View on PubMed)

Other Identifiers

IRCCSDonato Brugada-randomized

Identifier Type: -

Identifier Source: org_study_id