A Ring-type Wearable Device for Atrial Fibrillation | NCT04023188

Studies
A Ring-type Wearable Device for Atrial Fibrillation

NCT04023188

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Mar 18, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 23, 2018Actual

Primary Completion Date

Aug 30, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Jul 15, 2019

First Submission Date that Met QC Criteria

Jul 15, 2019

First Posted Date

Jul 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2020

Last Update Posted Date

Mar 18, 2020Actual

Name	Class
Sky Labs Inc.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Study title: Diagnostic Performance of a Ring-type Wearable Device Using Deep Learning Analysis of Photoplethysmographic Signals for Detecting Atrial Fibrillation.
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.
Study period: From the date of IRB approval to 31th Dec. 2019.
The size of study population: 200 participants
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

A participant is under the routine procedures of direct-current cardioversion.
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.
Recorded signals are evaluated without encompassing persornal information. 11. Financial benefits to the participants: None.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eue-Keun Choi, MD, PhD	Devision of Cardiology, Department of Internal Medicine, Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National university Hostpital		Seoul		03080	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32348254	Derived	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.

ID	Term
D001281	Atrial Fibrillation
D004194	Disease

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes