CompletedNot Applicable

High Density Mapping in Brugada Syndrome

Belgium15 participantsStarted 2018-04-01

Plain-language summary

The current study has the following objectives: 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. 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.

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

HD-grid electrograms

Timeframe: During ablation

Trial details

NCT IDNCT06567639

SponsorUniversitair Ziekenhuis Brussel

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-03-31

View on ClinicalTrials.gov More Brugada Syndrome trials