A Ring-type Wearable Device for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04023188
• Other study ID #: CART2
• Status: Active, not recruiting
• Start date: January 23, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Korea, Republic of	Seoul National university Hostpital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Sky Labs Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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