UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057133 |
|---|---|
| Receipt number | R000065306 |
| Scientific Title | Evaluation of the Efficacy and Safety of Low-Radiation Exposure Ablation Therapy |
| Date of disclosure of the study information | 2025/02/26 |
| Last modified on | 2025/02/26 11:26:05 |
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Basic information
Public title
Evaluation of the Efficacy and Safety of Ablation Therapy with Minimally Reduced Radiation Exposure
Acronym
Low-radiation Ablation Procedure
Scientific Title
Evaluation of the Efficacy and Safety of Low-Radiation Exposure Ablation Therapy
Scientific Title:Acronym
Low-radiation Ablation Procedure
Region
| Japan |
Condition
Condition
Non-valvular atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Atrial fibrillation ablation requires fluoroscopic guidance; however, to minimize radiation exposure, we have developed a near-zero fluoroscopy protocol. For the widespread adoption of this protocol, it is essential to validate its efficacy and safety. This study aims to evaluate whether the "near-zero fluoroscopy protocol" demonstrates equivalent safety and clinical outcomes compared to conventional procedures while achieving a significant reduction in radiation exposure.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence or absence of atrial fibrillation recurrence within one year after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional Treatment Group
Interventions/Control_2
Near-Zero Treatment Group
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
From the date of approval by the head of the research institution until December 31, 2024, patients undergoing their first catheter ablation for non-valvular atrial fibrillation at the Department of Cardiology, Nippon Medical School Hospital, who have been provided with an explanation of this study using an informed consent document and have given their consent, will be included in the study.
Key exclusion criteria
Individuals with underlying heart diseases such as valvular disease or cardiomyopathy; those with a history of catheter ablation for non-valvular atrial fibrillation; individuals who are pregnant or wish to become pregnant. However, men whose partners wish to become pregnant will not be considered exclusion criteria. Additionally, individuals deemed inappropriate for participation in this study by the principal investigator or co-investigators will also be excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Iwasaki |
Organization
Nippon Medical School
Division name
Cardiovascular Medicine
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
iwasaki@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Iwasaki |
Organization
Nippon Medical School
Division name
Cardiovascular Medicine
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
iwasaki@nms.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Yuki Iwasaki
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Nippon Medical School
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
iwasaki@nms.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 | 02 | Month | 26 | 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
Suspended
Date of protocol fixation
| 2024 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 02 | Month | 26 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065306
