Performance verification test of a software medical device with artificial intelligence to detect signs of paroxysmal atrial fibrillation

Performance verification test of a software medical device with artificial intelligence to detect signs of paroxysmal atrial fibrillation - Performance verification test of a software medical device with artificial intelligence to detect signs of paroxysmal atrial fibrillation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047182

Enrollment

Registered

2022-03-16

Start date

2021-09-17

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

paroxysmal atrial fibrillation

Interventions

Artificial Intelligence Enabled EDC Analysis System

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Paroxysmal atrial fibrillation group 1.Persons who have given written consent 2.Persons diagnosed as paroxysmal atrial fibrillation 3.Persons expected to have an atrial fibrillation attack more frequency than once a week Control group 1.Persons with confirmed sinus rhythm

Exclusion criteria

Exclusion criteria: Paroxysmal atrial fibrillation group 1.Persons diagnosed with persistent or permanent atrial fibrillation 2.Persons undergoing treatment(catheter ablation, open heart surgery, pacemaker implantation, percutaneous atrial septal defect closure) Control group 1.Persons who have a history of diagnosis of paroxysmal atrial fibrillation, persistent atrial fibrillation, or permanent atrial fibrillation 2.Persons undergoing treatment(catheter ablation, open heart surgery, pacemaker implantation, percutaneous atrial septal defect closure)

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity for the results of sign detection	—

Countries

Japan

Contacts

Public ContactChieko Akiyama

International University of Health and Welfare, Mita Hospital Clinical Trial Management Office

minamikawa@iuhw.ac.jp0334518175

Outcome results

None listed

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