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| Name | Class |
|---|---|
| Sky Labs Inc. | UNKNOWN |
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This study investigates diagnostic performance of a ring-type wearable device for detecting atrial fibrillation. This is a prospective cohort registry study began after the date of IRB approval and until 31th Dec. 2023. The eligible criteria are (1) those who admitted the institution for elective direct-current cardioversion or catheter ablation of persistent atrial fibrillation, (2) those who were successfully converted to sinus rhythm after the intervention, and (3) aged 19 years or more. The exclusion criteria are (1) those aged less than 19 years, (2) those who are not converted to sinus rhythm after the intervention, and (3) those who are not eligible to measure photoplethysmographic signals. This study aims to recruit 100 participants in total. The participants are required to record photoplethysmographic signals by the ring device in addition to routine procedures of direct-current cardioversion or catheter ablation, hence, the study is at minimal risk.
(1) Those with persistent atrial fibrillation (2) Those who admitted the institution for elective direct-current cardioversion or catheter ablation (3) Those who are successfully converted to sinus rhythm (4) Those aged 19 years or more
9. The exclusion criteria:
10. Procedures of the study
11. Financial benefits to the participants: None.
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance | Diagnostic performance of a ring-type wearable device for detecting atrial fibrillation (parameters including sensitivity, specificity, positive predictive value, negative predictive value). | 1 month (from the discharge to the next outpatient clinic) |
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Inclusion Criteria:
Exclusion Criteria:
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The study consecutively recruits participants who admitted for elective direct-current cardioversion or catheter ablation due to persistent atrial fibrillation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eue-Keun Choi, MD, PhD | Contact | +82-2-2072-0688 | choiek417@gmail.com | |
| Soonil Kwon, MD | Contact | +82-10-9498-1664 | david.soonil.kwon@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Eue-Keun Choi, MD, PhD | Devision of Cardiology, Department of Internal Medicine, Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National university Hostpital | Recruiting | Seoul | 03080 | South Korea |
Currently, according to the decision with IRB of the institution, the IPD is not planned to be shared with other researchers for the purpose of protecting potential privacy issues of the participants.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |