NCT06988189

Unmasking Concealed Arrhythmia Syndromes

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

This study seeks to evaluate whether using non-invasive electrocardiograph (ECG) techniques, including long term ECG monitoring with wearable ECGs, can improve the detection of concealed Brugada syndrome.

Detailed description

Application of long term continuous ECG monitoring via ECG wearables and ambulatory ECG monitors to detect manifestations of Brugada syndrome. This approach will be combined with development of an AI (artificial intelligence) enabled ECG platform to automate Brugada ECG detection and analysis. The protocol will comprise the following parts: Study A: Brugada ECG AI development. This will automate the recognition of the type 1 Brugada ECG pattern on 12 lead ECGs. Study B: Remote arrhythmia diagnostics. A prospective observational study whereby recruited participants will be fitted with a wearable ECG or cardiac monitor to undergo continuous long term ambulatory ECG monitoring. The algorithms developed in study A will be applied to long term ECG data captured in this study. Study C: Arrhythmic risk stratification using ultra-high-frequency ECG. This exploratory study will look for markers of arrhythmic risk in patients with manifest and concealed arrhythmia syndromes.

Conditions

• Brugada ECG Patterns
• Brugada Syndrome (BrS)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	12-lead ECG	12-lead ECG from a conventional ECG machine
DIAGNOSTIC_TEST	Continuous long term ambulatory ECG monitoring	Continuous long term ambulatory ECG monitoring using wearable ECG or cardiac monitor
DIAGNOSTIC_TEST	Ultra-high-frequency ECG	Ultra-high-frequency ECG acquired using specific acquisition equipment

Timeline

• Start date: 2024-09-09
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-05-23
• Last updated: 2025-05-23

Locations

1 site across 1 country: United Kingdom