UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057831 |
|---|---|
| Receipt number | R000066096 |
| Scientific Title | Atrial Fibrillation Recurrence Classifier using Artificial Intelligence |
| Date of disclosure of the study information | 2025/05/11 |
| Last modified on | 2025/05/11 14:48:30 |
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Basic information
Public title
Prediction of recurrence in catheter ablation for atrial fibrillation using artificial intelligence
Acronym
Prediction of recurrence in catheter ablation for atrial fibrillation using artificial intelligence
Scientific Title
Atrial Fibrillation Recurrence Classifier using Artificial Intelligence
Scientific Title:Acronym
ARC-AI
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Atrial fibrillation (AF) is one of the most common arrhythmia detected in clinical practice. Moreover, this arrhythmia increases the risk of stroke, heart failure, and all-cause-mortality. Among the treatment options, including antiarrhythmic agent therapy and radiofrequency catheter ablation, ablation has become the first-line therapy owing to lower rates of recurrence.
However, recurrence rates are significantly higher in patients with long-standing AF compared to those with newly diagnosed or paroxysmal AF. Therefore, although restoration of sinus rhythm may be possible, such patients often avoid catheter ablation. As such, the a tool capable of predicting the AF recurrence following catheter ablation has become necessary in recent years. The purpose of this study is to investigate this using artificial intelligence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Atrial fibrillation recurrence following catheter ablation.
Key secondary outcomes
By examining the rationale behind the AI's predictions of AF recurrence, we aim to investigate the underlying mechanisms of recurrence.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo their first catheter ablation are planned to be included
Key exclusion criteria
Patients who do not meet the age criteria will be excluded.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Hoshiyama |
Organization
Kumamoto University Hospital
Division name
Cardiovascular medicine
Zip code
860-8556
Address
1-1-1 honjo Kumamoto City
TEL
096-373-5175
tadashi@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Hoshiyama |
Organization
Kumamoto University
Division name
Cardiovascular medicine
Zip code
860-8556
Address
1-1-1 honjo Kumamoto city
TEL
096-373-5175
Homepage URL
tadashi@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
There is no funding source related to this investigation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University Hospital
Address
1-1-1 honjo Kumamoto city
Tel
096-373-5657
ski-shien@jimu.kumamoto-u.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
| 2025 | Year | 05 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There is no other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 11 | Day |
Last modified on
| 2025 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066096
