A Ring-type Wearable Device for Atrial Fibrillation

CART Phase 2 Study: Diagnostic Performance of a Ring-type Wearable Device Using Deep Learning Analysis of Photoplethysmographic Signals for Detecting Atrial Fibrillation

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. 2019. The eligible criteria are (1) those who admitted the institution for elective direct-current cardioversion of persistent atrial fibrillation, and (2) aged 19 years or more. The exclusion criteria are (1) those aged less than 19 years, (2) those who are not eligible to perform cardioversion by any reasons. This study aims to recruit 200 participants in total. The participants are required to record photoplethysmographic signals by the ring device in addition to routine procedures of direct-current cardioversion, hence, the study is at minimal risk.

Study Overview

• Status: Unknown
• Conditions: 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.
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.
6. Study period: From the date of IRB approval to 31th Dec. 2019.
7. The size of study population: 200 participants
8. 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

1. A participant is under the routine procedures of direct-current cardioversion.
2. On admission, a participant is given with detailed information of the study.
3. After the informed consent, the only additional procedure due to the study is recording photoplethysmographic signal by wearing a ring-type device.
4. Recorded signals are evaluated without encompassing persornal information. 11. Financial benefits to the participants: None.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National university Hostpital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study consecutively recruits participants who admitted for elective direct-current cardioversion due to persistent atrial fibrillation.

Description

Inclusion Criteria:

• Those with persistent atrial fibrillation
• Those who admitted for elective direct-current cardioversion
• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).	Baseline

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Sky Labs Inc.
• Investigators: Principal Investigator: Eue-Keun Choi, MD, PhD, Devision of Cardiology, Department of Internal Medicine, Seoul National University Hospital

Publications and helpful links

General Publications

• Kwon S, Hong J, Choi EK, Lee B, Baik C, Lee E, Jeong ER, Koo BK, Oh S, Yi Y. Detection of Atrial Fibrillation Using a Ring-Type Wearable Device (CardioTracker) and Deep Learning Analysis of Photoplethysmography Signals: Prospective Observational Proof-of-Concept Study. J Med Internet Res. 2020 May 21;22(5):e16443. doi: 10.2196/16443.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2018
• Primary Completion (Anticipated): August 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: atrial fibrillation; diagnosis; photoplethysmography; deep learning; wearable electronic devices
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CART2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No