A Ring-type Wearable Device for Atrial Fibrillation

NCT04023188 | Unknown

• 1 other identifier: CART2
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; deep learning; diagnosis; photoplethysmography; wearable electronic devices

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Those with persistent atrial fibrillation
• Those who admitted for elective direct-current cardioversion
• Those who aged 19 years or more

You may not qualify if:

• Those who aged less than 19 years
• Those who had other types of cardiac arrhythmias
• Those who are not eligible to perform electrical cardioversion

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Sky Labs Inc.: collaborator

Study Sites (1)

Seoul National university Hostpital

Seoul, 03080, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32348254 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Disease

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eue-Keun Choi, MD, PhD

  Devision of Cardiology, Department of Internal Medicine, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: January 23, 2018
• Primary Completion: August 30, 2020
• Study Completion: December 31, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

KR (1)