Atrial Fibrillation Screening With MobiCARE in Subjects W... | NCT06036342

Studies
Atrial Fibrillation Screening With MobiCARE in Subjects With Health Care Examination

NCT06036342

Sponsor

Seoul National University Hospital

Status

Active, not recruiting

Last Update Posted

May 18, 2025Actual

Enrollment

3,000Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

MobiCARE test

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2022Actual

Primary Completion Date

Dec 10, 2024Actual

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 20, 2023

First Submission Date that Met QC Criteria

Sep 6, 2023

First Posted Date

Sep 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2025

Last Update Posted Date

May 18, 2025Actual

Name	Class
Daewoong Pharmaceutical Co. LTD.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aimed to detect and diagnose atrial fibrillation early by conducting a screening test for atrial fibrillation using a continuous electrocardiography monitoring device for those who have undergone a health screening examination.

Early detection through atrial fibrillation screening tests in high-risk patients with stroke is intended to prevent stroke by starting stroke prevention treatment early. It is intended to detect asymptomatic atrial fibrillation patients early through examination and ultimately improve the quality of life.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Actual

Name	Type	Description	Arm Group Labels	Other Names
MobiCARE test	Diagnostic Test	7-days continuous electrocardiography monitoring using MobiCARE device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Atrial fibrillation detection rate	Atrial fibrillation detection rate at 1-year follow-up time	1 year

Secondary Outcomes

Measure	Description	Time Frame
The detection rate of atrial fibrillation	The detection rate of atrial fibrillation	up to 7 days
The burden of atrial fibrillation.	The burden of atrial fibrillation.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects aged 65 years or older who have at least one stroke risk factor*
Subjects aged 19 years to <65 years who have two or more stroke risk factors.
Subjects aged 75 years or older
- Stroke risk factors: heart failure, hypertension, diabetes, vascular disease, women, stroke/systemic embolism/transient ischemic attack (although stroke/systemic embolism/transient ischemic attack among stroke risk factors is considered to have two risk factors)
- Heart failure: a history of heart failure diagnosis or a history of current heart failure treatment.
- Hypertension, Diabetes: Diagnostic History
- Vascular diseases: Significant coronal atherosclerosis (when 70% or more of the computed tomography or coronary angiography is present or coronary intervention is performed), 50% or more of the carotid artery disease, peripheral vascular disease, history of myocardial infarction, and aortic plaques

Exclusion Criteria:

Subjects diagnosed with atrial fibrillation in the past
Subjects aged under 19 years and other vulnerable research subjects
Subjects who have patch-type adhesive allergies/atopy dermatitis/ urticaria/skin rash/hives that are difficult to apply patches continuously
Subjects who have a structural abnormality in the thorax and is difficult to attach the device.
Subjects who have cardiac implantable electronic device (pacemaker, implantable cardioverter-defibrillator, implantable loop recorder, or cardiac resynchronized therapy-pacemaker or defibrillator)
Subjects requiring immediate ECG analysis or ECG monitoring through hospitalization due to arrhythmia that can be life-threatening
Subjects who are deemed inappropriate to participate in the research as judged by the researcher for other reasons.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Those who have undergone a health screening examination.

Sampling Method

Probability Sample

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes