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

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ClinicalTrials.gov Identifier: NCT04024124
Recruitment Status : Not yet recruiting
First Posted : July 18, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Sky Labs Inc.
Information provided by (Responsible Party):
Eue-Keun Choi, Seoul National University Hospital

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.

Condition or disease
Atrial Fibrillation

Detailed Description:
  1. Study title: Diagnostic Performance of a Ring-type Wearable Device Using Deep Learning Analysis of Photoplethysmographic Signals for Detecting Atrial Fibrillation Among Ambulatory Patients.
  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 among ambulatory patients.
  6. Study period: From the date of IRB approval to 31th Dec. 2023.
  7. The size of study population: 100 participants
  8. 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

9. The exclusion criteria:

  1. Those with other forms of cardiac arrhythmias
  2. Those aged less than 19 years
  3. Those who are not eligible to perform electrical cardioversion or catheter ablation
  4. Those who are not converted to sinus rhythm after the intervention

10. Procedures of the study

  1. A participant is under the routine procedures of direct- current cardioversion or catheter ablation.
  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. The participant is instructed how to use the ring device.
  4. Recorded signals are evaluated without encompassing persornal information.
  5. 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.
  6. 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.
  7. 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.

11. Financial benefits to the participants: None.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
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
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024124


Contacts
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Contact: Eue-Keun Choi, MD, PhD +82-2-2072-0688 choiek417@gmail.com
Contact: Soonil Kwon, MD +82-10-9498-1664 david.soonil.kwon@gmail.com

Locations
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Korea, Republic of
Seoul National university Hostpital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Sky Labs Inc.
Investigators
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Principal Investigator: Eue-Keun Choi, MD, PhD Devision of Cardiology, Department of Internal Medicine, Seoul National University Hospital

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Responsible Party: Eue-Keun Choi, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04024124     History of Changes
Other Study ID Numbers: CART3
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eue-Keun Choi, Seoul National University Hospital:
Atrial fibrillation
Deep learning
Diagnosis
Photoplethysmography
Wearable electronic devices
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes