A Ring-type Wearable Device for Atrial Fibrillation Among Ambulatory Patients

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04024124
• Collaborator: Sky Labs Inc. (Other)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 50.7
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation

Detailed Description

1. Study title: Diagnostic Performance of a Ring-type Wearable Device Using Deep Learning Analysis of Photoplethysmographic Signals for Detecting Atrial Fibrillation Among Ambulatory Patients.

2. Study type: Investigator initiated study.

3. Study design: Prospective observational cohort registry design.

4. Sponsor: Sky Labs, Inc., Republic of Korea.

5. The aim of the study: To evaluate diagnostic performance of a ring-type wearable device for detecting atrial fibrillation among ambulatory patients.

6. Study period: From the date of IRB approval to 31th Dec. 2023.

7. The size of study population: 100 participants

8. 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

1. The exclusion criteria:

2. Those with other forms of cardiac arrhythmias

3. Those aged less than 19 years

4. Those who are not eligible to perform electrical cardioversion or catheter ablation

5. Those who are not converted to sinus rhythm after the intervention

6. Procedures of the study

7. A participant is under the routine procedures of direct- current cardioversion or catheter ablation.

8. On admission, a participant is given with detailed information of the study.

9. 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.

10. Recorded signals are evaluated without encompassing persornal information.

11. 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.

12. 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.

13. 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.

14. Financial benefits to the participants: None.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: May 10, 2019
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Outcome Measures

Primary Outcome Measures

1. Diagnostic performance [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Those with persistent atrial fibrillation

• Those who admitted for elective direct-current cardioversion or catheter ablation

• Those who are successfully converted to sinus rhythm

• Those who aged 19 years or more

Exclusion Criteria:

• Those who aged less than 19 years

• Those who had other types of cardiac arrhythmias

• Those who are not eligible to perform electrical cardioversion or catheter ablation

• Those who are not converted to sinus rhythm

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National university Hostpital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital
• Sky Labs Inc.

Investigators

• Principal Investigator: Eue-Keun Choi, MD, PhD, Devision of Cardiology, Department of Internal Medicine, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eue-Keun Choi, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04024124
• Other Study ID Numbers: CART3
• First Posted: Jul 18, 2019
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eue-Keun Choi, Professor, Seoul National University Hospital: Atrial fibrillation; Deep learning; Diagnosis; Photoplethysmography; Wearable electronic devices
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Mar 18, 2020