UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057737 |
|---|---|
| Receipt number | R000065903 |
| Scientific Title | Evaluation of Radiation Dose Reduction During Radiofrequency Catheter Ablation |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2026/06/05 07:26:55 |
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Basic information
Public title
Evaluation of Radiation Dose Reduction and Safety of a Novel Fluoroscopy Filter Function During Radiofrequency Catheter Ablation for Atrial Fibrillation
Acronym
Evaluation of Radiation Dose Reduction and Safety of a Novel Fluoroscopy Filter Function During Radiofrequency Catheter Ablation for Atrial Fibrillation
Scientific Title
Evaluation of Radiation Dose Reduction During Radiofrequency Catheter Ablation
Scientific Title:Acronym
Evaluation of Radiation Dose Reduction During Radiofrequency Catheter Ablation
Region
| Japan |
Condition
Condition
Atrial Fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of SPOT ROI in reducing radiation dose during radiofrequency catheter ablation for atrial fibrillation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment success rate, procedure duration (minutes), fluoroscopy time (minutes), patient radiation dose (cGy*cm2), perioperative complication rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are 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
Intervention: Patients undergoing radiofrequency catheter ablation for atrial fibrillation using the Spot ROI fluoroscopy filter function on the Alphenix system (Canon Medical Systems Corp.)
Interventions/Control_2
Control: Patients undergoing radiofrequency catheter ablation for atrial fibrillation using conventional fluoroscopy filters
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older undergoing initial radiofrequency catheter ablation for atrial fibrillation at our institution
Key exclusion criteria
Patients undergoing catheter ablation for other arrhythmias at the same time
Patients with significantly reduced cardiac function, severe heart failure, or congenital heart disease
Patients who are unable or unwilling to provide informed consent
Patients deemed inappropriate for the study by the principal or sub-investigators
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hidehiro |
| Middle name | |
| Last name | Iwakawa |
Organization
Akita University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
010-8543
Address
1-1-1 Hondo, Akita City, Akita
TEL
018-884-6110
iwakawa@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Suzuki |
Organization
Akita University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
010-8543
Address
1-1-1 Hondo, Akita City, Akita
TEL
018-884-6110
Homepage URL
nsuzuki@med.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee for Clinical Research, Akita University, National University Corporation
Address
1-1-1 Hondo, Akita City, Akita
Tel
018-884-6110
nintei@hos.akita-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 | 01 | 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
| 2024 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2046 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2046 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2046 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2046 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2046 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2046 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 29 | Day |
Last modified on
| 2026 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065903
