A Ring-type Wearable Device for Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT04023188|
Recruitment Status : Active, not recruiting
First Posted : July 17, 2019
Last Update Posted : July 19, 2019
|Condition or disease|
- Study title: Diagnostic Performance of a Ring-type Wearable Device Using Deep Learning Analysis of Photoplethysmographic Signals for Detecting Atrial Fibrillation.
- Study type: Investigator initiated study.
- Study design: Prospective observational cohort registry design.
- Sponsor: Sky Labs, Inc., Republic of Korea.
- The aim of the study: To evaluate diagnostic performance of a ring-type wearable device for detecting atrial fibrillation.
- Study period: From the date of IRB approval to 31th Dec. 2019.
- The size of study population: 200 participants
- The eligibility criteria:
(1) Those with persistent atrial fibrillation (2) Those who admitted the institution for elective direct-current cardioversion (3) Those aged 19 years or more 9. The exclusion criteria:
(1) Those with other forms of cardiac arrhythmias (2) Those aged less than 19 hears (3) Those who are not eligible to perform electrical cardioversion 10. Procedures of the study
- A participant is under the routine procedures of direct-current cardioversion.
- On admission, a participant is given with detailed information of the study.
- After the informed consent, the only additional procedure due to the study is recording photoplethysmographic signal by wearing a ring-type device.
- Recorded signals are evaluated without encompassing persornal information. 11. Financial benefits to the participants: None.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||CART Phase 2 Study: Diagnostic Performance of a Ring-type Wearable Device Using Deep Learning Analysis of Photoplethysmographic Signals for Detecting Atrial Fibrillation|
|Actual Study Start Date :||January 23, 2018|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 30, 2019|
- Diagnostic performance [ Time Frame: Baseline ]Diagnostic performance of a ring-type wearable device for detecting atrial fibrillation (parameters including sensitivity, specificity, positive predictive value, negative predictive value).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023188
|Korea, Republic of|
|Seoul National university Hostpital|
|Seoul, Korea, Republic of, 03080|
|Principal Investigator:||Eue-Keun Choi, MD, PhD||Devision of Cardiology, Department of Internal Medicine, Seoul National University Hospital|