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

NCT04024124 | Unknown

• 1 other identifier: CART3
• Study Type: observational
• Target: 100
• 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. 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.

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).

  1 month (from the discharge to the next outpatient clinic)

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 or catheter ablation due to persistent atrial fibrillation.

You may qualify if:

• 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

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 or catheter ablation
• Those who are not converted to sinus rhythm

Sponsors & Collaborators

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

Study Sites (1)

Seoul National university Hostpital

Seoul, 03080, South Korea

RECRUITING

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

Central Study Contacts

Eue-Keun Choi, MD, PhD

CONTACT

+82-2-2072-0688; choiek417@gmail.com

Soonil Kwon, MD

CONTACT

+82-10-9498-1664; david.soonil.kwon@gmail.com

Study Design

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

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: May 10, 2019
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

KR (1)