High Density Mapping in Brugada Syndrome

NCT06567639 | Completed

• 1 other identifier: BRS-EPI
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The current study has the following objectives:

1. 1.To characterize the changes in amplitude and duration of epicardial right ventricular outflow tract electrograms captured through a multipolar mapping catheter in patients with Brugada syndrome before and after an ajmaline challenge.
2. 2.To investigate the relationship between the above cited invasive electrophysiological findings and non invasive ECG imaging (ECGI) of the epicardial layer of the right ventricular outflow tract (RVOT) of patients affected by Brugada syndrome and undergoing substrate thoracoscopic catheter ablation.

Conditions

Brugada Syndrome

Outcome Measures

Primary Outcomes (1)

• HD-grid electrograms

  EGMs on HD-grid will be analyzed in detail by two physicians.

  During ablation

Interventions

Catheter ablation PROCEDURE

Hybrid epicardial right ventricular (RVOT-EPI) mapping and Brugada syndrome substrate ablation technique. The procedure is performed in the hybrid operating room. The Advisor™ HD-Grid Mapping Catheter is delivered inside the chest through a working port and positioned under thoracoscopic view over the pulmonary artery that is consequently labeled on EAM. As a standard protocol the mapping catheter is positioned over the pulmonary artery and moved down progressively over the RVOT-EPI under continuous thoracoscopic view and at least three consecutive beats are required for each recording location point with a stable catheter position.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients who underwent hybrid thoracoscopic substrate ablation for Brugada syndrome at Universitair Ziekenhuis Brussel (UZB), between April 2018 and March 2021 will be retrospectively analyzed and included in the study.

You may qualify if:

• high density epicardial EAM performed with the multipolar mapping catheter Advisor™ HD-Grid Mapping Catheter, (Abbott Labs, Abbott Park, IL, USA) in association with the EnSite Precision™ Cardiac Mapping System, (Abbott Labs, Abbott Park, IL, USA);
• epicardial EAM performed before and after ajmaline infusion at standard protocol (1 mg/kg in 5 minutes);
• ECGI activation map performed before and after ajmaline and concomitant with invasive EAM acquisition.

You may not qualify if:

• Spontaneous BrS type I pattern ECG during EAM acquisition. Patients were included if they had a history of spontaneous BrS type I;
• other diagnosis different from BrS syndrome or overlap syndrome diagnosis by means of genetic analysis, transthoracic echocardiography, computed tomography (CT) or magnetic resonance imaging;
• use of a different mapping catheter or mapping system;
• history of previous BrS substrate ablation.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZB

Brussels, Belgium

Location

MeSH Terms

Conditions

Brugada Syndrome

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 23, 2024
• Study Start: April 1, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)