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

Not Applicable

• Conditions: paroxysmal atrial fibrillation; Atrial Fibrillation; D001281

• Registration Number: JPRN-jRCT2032220573
• Lead Sponsor: Tamura Yuichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 45

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity for the results of sign detection

Secondary Outcome Measures

Name	Time	Method
- AUC of ROC curve for sensitivity and specificity of diagnostic accuracy of detection of signs of paroxysmal atrial fibrillation in 25 patients in the paroxysmal atrial fibrillation group and 20 patients in the control group<br>- Changes in the number of targeted blocks and in sensitivity and specificity for each case<br>- Differences in sensitivity and specificity due to differences in block taking (10 consecutive blocks vs. 10 blocks independent in time) for each case<br>- Type and number of adverse events<br>- Type and number of Investigational device failure<br>- Aggregation of vital signs and subjective symptoms