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Clinical trial on the diagnostic sensitivity of atrial fibrillation using a portable electrocardiograph for home use

Clinical trial on the diagnostic sensitivity of atrial fibrillation using a portable electrocardiograph for home use - Clinical trial on the diagnostic sensitivity of atrial fibrillation using a portable electrocardiograph for home use

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057225
Enrollment
250
Registered
2025-03-06
Start date
2025-03-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation

Interventions

Patients with a suspected arrhythmia who have undergone a 24-hour ECG test with no abnormalities will be monitored remotely for six months using the HCG-8060T home-use portable electrocardiograph (Omr

Sponsors

Fukushima Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Those who have undergone 24-hour ECG test (2) Those who are 45 years of age or older at the time of obtaining consent, or individuals aged 18 or older with underlying cardiovascular conditions (3) Those who have a smartphone running the Omron Connect app (4) Those who have requested home electrocardiogram measurement using a portable electrocardiograph (5) Those who wish to have a telehealth medical consultation to communicate suspected findings (6) Those who agree to participate in this study.

Exclusion criteria

Exclusion criteria: (1) Patients diagnosed with persistent atrial fibrillation (2) Patients receiving anti-arrhythmic drugs (3) Pregnant or possibly pregnant (4) Patients with drug dependence or psychiatric disorders (5) Patients participating in other clinical trials (6) Patients with other serious diseases (7) Patients who are deemed inappropriate by the physician

Design outcomes

Primary

MeasureTime frame
Total diagnosis rate per month of paroxysmal atrial fibrillation diagnosed when a portable electrocardiograph is used in persons whose atrial fibrillation was not detected by 24-hour Holter ECG

Secondary

MeasureTime frame
(1) Usage of portable electrocardiographs (by day, by time of day, etc.) (2) Total number of paroxysmal atrial fibrillation detected (individual and population) (3) Detection rate by measurement compliance (adjusted by measurement frequency) (4) Rate of visits to secondary medical institutions (research institutions) by persons suspected of having paroxysmal atrial fibrillation based on the measurement results of portable electrocardiographs (5) Reasons why persons suspected of having paroxysmal atrial fibrillation based on the measurement results of the portable electrocardiograph did not visit a secondary medical institution. (6) Correlation between diagnosis status of paroxysmal atrial fibrillation and various survey items

Countries

Japan

Contacts

Public ContactJunichi Yatabe

Fukushima Medical University, School of Medicine Department of Digital Health Services Research

jyatabe@fmu.ac.jp024-547-1206

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026