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A Ring-type Wearable Device for Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT04023188
Recruitment Status : Active, not recruiting
First Posted : July 17, 2019
Last Update Posted : July 19, 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. 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.

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.
  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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
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
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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).



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 due to persistent atrial fibrillation.
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

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): NCT04023188


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: NCT04023188     History of Changes
Other Study ID Numbers: CART2
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 19, 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