NCT06236776

AWARE Registry: Wearable ECG in Structural Heart Interventions

Arrhythmia Assessment in Structural Cardiac Interventions Using Wearable ECG Monitoring: AWARE Registry

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center (Sinchon Severance hospital / Gangnam Severance hospital), prospective cohort observational study to patients who had undergone structural heart intervention including device closure for secundum type atrial septal defect or Patent foramen ovale. Transthoracic echocardiography will be performed before the procedure, immediately after, and at 6, 18, 30 months after the procedure. Wearable ECG monitoring (\> 3 days) will be performed before the procedure or immediately after procedure. Demographic, laboratory, hemodynamic data during procedure, and non-invasive imaging dat are obtained.

Conditions

• Atrial Septal Defect
• Patent Foramen Ovale

Timeline

• Start date: 2024-02-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2024-02-01
• Last updated: 2024-02-01

Locations

1 site across 1 country: South Korea