Feasibility of Improving Risk Stratification in Brugada Syndrome (NCT03992677) | Clinical Trial Compass
CompletedNot Applicable
Feasibility of Improving Risk Stratification in Brugada Syndrome
United Kingdom45 participantsStarted 2017-12-01
Plain-language summary
Feasibility of Improving Risk Stratification in Brugada Syndrome (BrS), retrospective cohort study To study the reproducibility and specificity of V-CoS for activation heterogeneities predisposing to VT/VF in a larger series of BrS patients and determining the incidence of low V-CoS score in a larger cohort of control patients.
Population of 10 patients undergoing ablation for non-VT arrhythmia, 10 patients with atrial fibrillation, 10 relatives of BrS sufferers, who have confirmation of no pathology,10 patients with previous out-of-hospital cardiac arrest due to ischaemia, but with full revascularisation and recovery of left ventricular function, 10 elite athletes, 50 BrS sufferers with previous sudden cardiac death or appropriate Implantable cardioverter-defibrillator (ICD) therapy for VT/VF.
DURATION 3 years
Who can participate
Age range
18 Years – 100 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
. Patients with Brugada syndrome requiring risk stratification
. Patients without Brugada syndrome acting as a control group
. Patients undergoing ablation with ECGi system for other arrhythmias
. Relatives of Brugada patients with confirmation of no pathology
. Out-of-hospital cardiac arrest primary PCI with full recovery of left ventricular function and full revascularisation (n=10)
Exclusion criteria
. Pregnancy or not using a highly effective form of contraception
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
1
Minimum of Ventricular Conduction Stability (V-CoS) score
. Patients who have contraindications to an electrophysiological study.
. Patients with no Brugada syndrome that are known to be high-risk for SCD for another reason e.g. Hypertrophic cardiomyopathy, ischaemic cardiomyopathy with severely impaired left ventricular function.