Arrhythmia Assessment in Structural Cardiac Interventions Using Wearable ECG Monitoring: AWARE Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Septal Defect
- Sponsor
- Yonsei University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Occurrence of atrial fibrillation
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Occurrence of atrial fibrillation
Time Frame: 30 month
Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring
Secondary Outcomes
- All cause-death(Immediate post-operative, 18 month , 30 month)
- hospitalization for heart failure(Immediate post-operative, 18 month , 30 month)
- new atrial tachycardia(Immediate post-operative, 18 month , 30 month)
- high burden of APC/PVC (>15%)(Immediate post-operative, 18 month , 30 month)
- new atrial fibrillation(Immediate post-operative, 18 month , 30 month)