UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047182 |
|---|---|
| Receipt number | R000053820 |
| Scientific Title | Performance verification test of a software medical device with artificial intelligence to detect signs of paroxysmal atrial fibrillation |
| Date of disclosure of the study information | 2022/03/16 |
| Last modified on | 2023/03/16 10:28:57 |
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Basic information
Public title
Performance verification test of a software medical device with artificial intelligence to detect signs of paroxysmal atrial fibrillation
Acronym
Performance verification test of a software medical device with artificial intelligence to detect signs of paroxysmal atrial fibrillation
Scientific Title
Performance verification test of a software medical device with artificial intelligence to detect signs of paroxysmal atrial fibrillation
Scientific Title:Acronym
Performance verification test of a software medical device with artificial intelligence to detect signs of paroxysmal atrial fibrillation
Region
| Japan |
Condition
Condition
paroxysmal atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the performance of an automatic ECG analysis system using artificial intelligence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity for the results of sign detection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Artificial Intelligence Enabled EDC Analysis System
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key 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
Key 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)
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Tamura |
Organization
International University of Health and Welfare, Shool of Medicine
Division name
Department of Cardiology
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku Tokyo
TEL
0334518175
u1@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Chieko |
| Middle name | |
| Last name | Akiyama |
Organization
International University of Health and Welfare, Mita Hospital
Division name
Clinical Trial Management Office
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku Tokyo
TEL
0334518175
Homepage URL
minamikawa@iuhw.ac.jp
Sponsor or person
Institute
IUHW
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
1-24-1,minami-aoyama,minato-ku,Tokyo
Tel
0476-35-5607
iuhw-irb@iuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 16 | Day |
Last modified on
| 2023 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053820
