Brugada Syndrome Substrate Characterization and Ablation

NCT05643209 | Recruiting

• 1 other identifier: MCH2022-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Independent, single center, prospective study, to evaluate the efficacy, in consecutive BrS patients undergoing catheter ablation, at medium-long term follow-up after epicardial substrate homogenization. The target area is defined collecting signals using high density and high resolution mapping with equi-spaced electrode array. The ablation of abnormal fragmented prolonged low-frequency ventricular electrograms is performed by contact force catheter.

Conditions

Brugada Syndrome

Outcome Measures

Primary Outcomes (1)

• Percentage of patients free from any clinical ventricular arrhythmia at a 3, 6-months and 12-months follow-up from the procedure.

  The primary aim of the study is the rate of success at medium-long term follow-up after epicardial substrate homogenization (ablating abnormal fragmented prolonged low-frequency ventricular electrograms) in consecutive brugada patients undergoing catheter ablation. The medium-long term success of the ablation is defined in terms of percentage of patients free from any clinical ventricular arrhythmia at a 3, 6-months and 12-months follow-up from the procedure.

  12-months

Secondary Outcomes (1)

• Collecting and analyzing data concerning late potential and voltage maps using different settings, vector data and speed maps, could be useful to better understand and describe the mechanism of this pathology.

  12 months

Study Arms (1)

consecutive patients

OTHER

20 patients clinically indicated for a endo-epicardial catheter-based mapping procedure for the treatment of ventricular tachycardia/ ventricular fibrillation substrate

Procedure: ablation

Interventions

ablation PROCEDURE

epicardial substrate homogenization (ablating abnormal fragmented prolonged low-frequency ventricular electrograms) in consecutive patients undergoing catheter ablation

consecutive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic patients diagnosed with BrS-ECG pattern of types 1 and 2, both spontaneous and arising after Ajmaline tests, already implanted with an ICD.
• Symptomatic patients are defined as those who present ≥1 documented episode of VT / VF in the 12 months prior to enrollment.
• Patients eligible for ablation with 3D high-density mapping system in accordance with national guidelines, IFU and according to medical decision;
• Adult patients able to provide written informed consent

You may not qualify if:

• Patients unable to provide written informed consent;
• Patients unable to guarantee their presence at future FU visits;
• Patients who, according to medical judgment, have a life expectancy of less than 12 months;
• Patients who have undergone cardiac ablation in the 90 days prior to enrollment.
• Patients who have had adverse events that have not been resolved after any invasive procedure;
• Women potentially pregnant or planning to become pregnant.

Sponsors & Collaborators

• Maria Cecilia Hospital: lead

Study Sites (1)

Maria Cecilia Hospital

Cotignola, Ravenna, 48033, Italy

RECRUITING

Related Publications (1)

• Iacopino S, Sorrenti PF, Petretta A, Colella J, Di Vilio A, Statuto G, Fabiano G, Campagna G, Peluso G, Fabiano E, Indellicati G, Brogneri S, Tremoli E, Mantovani L, Speziale G, Savini C, Tripodi A. Hybrid mini-thoracotomy for Brugada syndrome: epicardial substrate characterization and ablation-results from UNCOVER(BrS) study. Front Cardiovasc Med. 2025 Oct 28;12:1658355. doi: 10.3389/fcvm.2025.1658355. eCollection 2025.

  PMID: 41229453 DERIVED

MeSH Terms

Conditions

Brugada Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Saverio Iacopino, MD

  Maria Cecilia Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saverio Iacopino, MD

CONTACT

0545.217228; siacopino@gvmnet.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 8, 2022
• Study Start: February 1, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)