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

JRCT ID: jRCT2032220573

Registered date:17/01/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: paroxysmal atrial fibrillation
• Date of first enrollment: 20/10/2021
• Target sample size: 45
• Study type: Interventional

Intervention(s)

Purpose of intervention: Diagnosis
Type of intervention: Device,equipment
Intervention: Artificial Intelligence Enabled EDC Analysis System

Outcome(s)

• Primary Outcome: Sensitivity and specificity for the results of sign detection

Secondary Outcome

- 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
- Changes in the number of targeted blocks and in sensitivity and specificity for each case
- Differences in sensitivity and specificity due to differences in block taking (10 consecutive blocks vs. 10 blocks independent in time) for each case
- Type and number of adverse events
- Type and number of Investigational device failure
- Aggregation of vital signs and subjective symptoms

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include 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

Exclude 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)

Related Information

• Primary Sponsor: Tamura Yuichi
• Secondary Sponsor: Tamura Yuichi,AMED
• Secondary ID(s): UMIN000047182