Atrial FibrillationNCT04023188
A Ring-type Wearable Device for Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jan 2018to 31 Dec 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study consecutively recruits participants who admitted for elective direct-current cardioversion due to persistent atrial fibrillation.
Who may be able to join
- Those with persistent atrial fibrillation
- Those who admitted for elective direct-current cardioversion
- Those who aged 19 years or more
Who cannot join
- Those who aged less than 19 years
- Those who had other types of cardiac arrhythmias
- Those who are not eligible to perform electrical cardioversion
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, deep learning, diagnosis, photoplethysmography, wearable electronic devices
- Medical subject headings
- Atrial Fibrillation, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance
Diagnostic performance of a ring-type wearable device for detecting atrial fibrillation (parameters including sensitivity, specificity, positive predictive value, negative predictive value).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start23 Jan 2018
- Primary completion30 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sky Labs Inc.
- Responsible party
- Principal investigator, Eue-Keun Choi, Seoul National University Hospital
- Investigators
- Eue-Keun Choi, MD, PhD, Principal investigator, Devision of Cardiology, Department of Internal Medicine, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023188
- Sponsor's protocol ID
- CART2
- Status last verified
- Mar 2020
- First submitted
- 15 Jul 2019
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 32348254
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04023188
- Acronym / sponsor ID
- CART2
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, deep learning, diagnosis, photoplethysmography, wearable electronic devices
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Sky Labs Inc.
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study consecutively recruits participants who admitted for elective direct-current cardioversion due to persistent atrial fibrillation.
Key inclusion criteria (3 listed)
- Those with persistent atrial fibrillation
- Those who admitted for elective direct-current cardioversion
- Those who aged 19 years or more
Key exclusion criteria (3 listed)
- Those who aged less than 19 years
- Those who had other types of cardiac arrhythmias
- Those who are not eligible to perform electrical cardioversion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance
Time frame: Baseline
Diagnostic performance of a ring-type wearable device for detecting atrial fibrillation (parameters including sensitivity, specificity, positive predictive value, negative predictive value).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Derived from this study: PubMed 32348254Kwon 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.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eue-Keun Choi, MD, PhD principal investigator
Devision of Cardiology, Department of Internal Medicine, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04023188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.