AWARE Registry: Wearable ECG in Structural Heart Interventions

Not yet recruiting

• Conditions: Patent Foramen Ovale; Atrial Septal Defect

• Registration Number: NCT06236776
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-10
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-24
• Last Update Submitted: 2024-01-24
• Study Start: 2024-02
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Adult ≥ 19 year-old
• Patients who scheduled to perform percutaneous device closure for atrial septal defect or patent foramen ovale
• Patients provided with the written, informed consent to participate in this study

Exclusion Criteria

• Patients who had paroxysmal, persistent, or chronic AF
• Life expectancy < 12 months
• Subject who the investigator deems inappropriate to participate in this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of atrial fibrillation	30 month	Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring

Secondary Outcome Measures

Name	Time	Method
All cause-death	Immediate post-operative, 18 month , 30 month
hospitalization for heart failure	Immediate post-operative, 18 month , 30 month	hospitalization for heart failure: data from electronic medical record in Yonsei university health system
new atrial tachycardia	Immediate post-operative, 18 month , 30 month
high burden of APC/PVC (>15%)	Immediate post-operative, 18 month , 30 month	high burden of APC/PVC ( \>15%): on wearable ECG monitoring
new atrial fibrillation	Immediate post-operative, 18 month , 30 month

Trial Locations

Locations (1)

Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of