Atrial FibrillationNCT04024124
A Ring-type Wearable Device for Atrial Fibrillation Among Ambulatory Patients
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. 2023. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 May 2019to Aug 2023
- How long will I take part?
- 1 Month
- 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 or catheter ablation due to persistent atrial fibrillation.
Who may be able to join
- 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
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 or catheter ablation
- Those who are not converted to sinus rhythm
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National university Hostpital
Seoul, 03080
Euekeun Choi, M.D. Ph.D., 82+02-2072-0688, choiek417@gmail.com
About this study
Official title: CART Phase 3 Study: Diagnostic Performance of a Ring-type Wearable Device Using Deep Learning Analysis of Photoplethysmographic Signals for Detecting Atrial Fibrillation Among Ambulatory Patients
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.
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 Among Ambulatory Patients.
- 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 among ambulatory patients.
- Study period: From the date of IRB approval to 31th Dec. 2023.
- The size of study population: 100 participants
- The eligibility criteria: (1) Those with persistent atrial fibrillation (2) Those who admitted the institution for elective direct-current cardioversion or catheter ablation (3) Those who are successfully converted to sinus rhythm (4) Those aged 19 years or more
- The exclusion criteria:
- Those with other forms of cardiac arrhythmias
- Those aged less than 19 years
- Those who are not eligible to perform electrical cardioversion or catheter ablation
- Those who are not converted to sinus rhythm after the intervention
- Procedures of the study
- A participant is under the routine procedures of direct- current cardioversion or catheter ablation.
- 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. The participant is instructed how to use the ring device.
- Recorded signals are evaluated without encompassing persornal information.
- The participant is required to wear the ring device and Holter monitoring device, and record his or her photoplethysmographic signals with ambulatory electrocardiography during the day. The ring is designed to automatically record user's photoplethysmographic signals and wirelessly transmit the data to user's smartphone. Detailed timings of wearing on/off the ring device and the Holter device are informed by a designated research crew.
- The participant visits outpatient clinic as scheduled accordingly. At the clinic, the participant returns the ring device, Holter monitoring device, and the recorded data to the designated researcher crew.
- Throughout the study, there is no intervention to the participants. The only additional step due to the participation of the study is that wearing the ring device and Holter monitoring device during their daily lives until the next outpatient clinic.
- 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: 1 month (from the discharge to the next outpatient clinic)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start10 May 2019
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 100 participants (estimated)
- Target duration
- 1 Month
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
- NCT04024124
- Sponsor's protocol ID
- CART3
- Status last verified
- Mar 2020
- First submitted
- 16 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.
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 3 Study: Diagnostic Performance of a Ring-type Wearable Device Using Deep Learning Analysis of Photoplethysmographic Signals for Detecting Atrial Fibrillation Among Ambulatory Patients
- ClinicalTrials.gov ID
- NCT04024124
- Acronym / sponsor ID
- CART3
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Deep learning, Diagnosis, Photoplethysmography, Wearable electronic devices
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Sky Labs Inc.
- Study start
- 10 May 2019 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 18 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. 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.
Detailed description
- Study title: Diagnostic Performance of a Ring-type Wearable Device Using Deep Learning Analysis of Photoplethysmographic Signals for Detecting Atrial Fibrillation Among Ambulatory Patients.
- 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 among ambulatory patients.
- Study period: From the date of IRB approval to 31th Dec. 2023.
- The size of study population: 100 participants
- The eligibility criteria: (1) Those with persistent atrial fibrillation (2) Those who admitted the institution for elective direct-current cardioversion or catheter ablation (3) Those who are successfully converted to sinus rhythm (4) Those aged 19 years or more
- The exclusion criteria:
- Those with other forms of cardiac arrhythmias
- Those aged less than 19 years
- Those who are not eligible to perform electrical cardioversion or catheter ablation
- Those who are not converted to sinus rhythm after the intervention
- Procedures of the study
- A participant is under the routine procedures of direct- current cardioversion or catheter ablation.
- 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. The participant is instructed how to use the ring device.
- Recorded signals are evaluated without encompassing persornal information.
- The participant is required to wear the ring device and Holter monitoring device, and record his or her photoplethysmographic signals with ambulatory electrocardiography during the day. The ring is designed to automatically record user's photoplethysmographic signals and wirelessly transmit the data to user's smartphone. Detailed timings of wearing on/off the ring device and the Holter device are informed by a designated research crew.
- The participant visits outpatient clinic as scheduled accordingly. At the clinic, the participant returns the ring device, Holter monitoring device, and the recorded data to the designated researcher crew.
- Throughout the study, there is no intervention to the participants. The only additional step due to the participation of the study is that wearing the ring device and Holter monitoring device during their daily lives until the next outpatient clinic.
- Financial benefits to the participants: None.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
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 or catheter ablation due to persistent atrial fibrillation.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 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 or catheter ablation
- Those who are not converted to sinus rhythm
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: 1 month (from the discharge to the next outpatient clinic)
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.
- 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
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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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 4 inclusion and 4 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?
Contact Eue-Keun Choi, MD, PhD (+82-2-2072-0688, choiek417@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (time frame: 1 month (from the discharge to the next outpatient clinic)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.