A Ring-type Wearable Device for Atrial Fibrillation Among Ambulatory Patients
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|ClinicalTrials.gov Identifier: NCT04024124|
Recruitment Status : Not yet recruiting
First Posted : July 18, 2019
Last Update Posted : July 24, 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 Among Ambulatory Patients.
- 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 among ambulatory patients.
- Study period: From the date of IRB approval to 31th Dec. 2023.
- The size of study population: 100 participants
- The eligibility criteria:
(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:
- Those with other forms of cardiac arrhythmias
- Those aged less than 19 years
- Those who are not eligible to perform electrical cardioversion or catheter ablation
- Those who are not converted to sinus rhythm after the intervention
10. Procedures of the study
- A participant is under the routine procedures of direct- current cardioversion or catheter ablation.
- 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. The participant is instructed how to use the ring device.
- Recorded signals are evaluated without encompassing persornal information.
- The participant is required to wear the ring device and Holter monitoring device, and record his or her photoplethysmographic signals with ambulatory electrocardiography during the day. The ring is designed to automatically record user's photoplethysmographic signals and wirelessly transmit the data to user's smartphone. Detailed timings of wearing on/off the ring device and the Holter device are informed by a designated research crew.
- The participant visits outpatient clinic as scheduled accordingly. At the clinic, the participant returns the ring device, Holter monitoring device, and the recorded data to the designated researcher crew.
- Throughout the study, there is no intervention to the participants. The only additional step due to the participation of the study is that wearing the ring device and Holter monitoring device during their daily lives until the next outpatient clinic.
11. Financial benefits to the participants: None.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||1 Month|
|Official Title:||CART Phase 3 Study: Diagnostic Performance of a Ring-type Wearable Device Using Deep Learning Analysis of Photoplethysmographic Signals for Detecting Atrial Fibrillation Among Ambulatory Patients|
|Estimated Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2023|
- Diagnostic performance [ Time Frame: 1 month (from the discharge to the next outpatient clinic) ]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): NCT04024124
|Contact: Eue-Keun Choi, MD, PhDemail@example.com|
|Contact: Soonil Kwon, MDfirstname.lastname@example.org|
|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|