Patent Foramen Ovale Clinical Trial
Official title:
Arrhythmia Assessment in Structural Cardiac Interventions Using Wearable ECG Monitoring: AWARE Registry
Verified date | January 2024 |
Source | Yonsei University |
Contact | Iksung Cho |
Phone | 82-2-2228-8442 |
iksungcho[@]yuhs.ac | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | June 2028 |
Est. primary completion date | June 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of atrial fibrillation | Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring | Immediate post-operative | |
Primary | Occurrence of atrial fibrillation | Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring | 18 month | |
Primary | Occurrence of atrial fibrillation | Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring | 30 month | |
Secondary | All cause-death | Immediate post-operative, 18 month , 30 month | ||
Secondary | hospitalization for heart failure | hospitalization for heart failure: data from electronic medical record in Yonsei university health system | Immediate post-operative, 18 month , 30 month | |
Secondary | new atrial fibrillation | Immediate post-operative, 18 month , 30 month | ||
Secondary | new atrial tachycardia | Immediate post-operative, 18 month , 30 month | ||
Secondary | high burden of APC/PVC (>15%) | high burden of APC/PVC ( >15%): on wearable ECG monitoring | Immediate post-operative, 18 month , 30 month |
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