UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061777 |
|---|---|
| Receipt number | R000070647 |
| Scientific Title | Prospective Registry Study on the Association of Body Composition, Left Atrial Low-Voltage Substrate, and Clinical Outcomes in Patients Undergoing First-Time Catheter Ablation for Atrial Fibrillation |
| Date of disclosure of the study information | 2026/06/03 |
| Last modified on | 2026/06/03 07:52:23 |
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Basic information
Public title
Study on Body Composition and Clinical Course in Patients Undergoing Catheter Ablation for Atrial Fibrillation
Acronym
AF Body Composition Study
Scientific Title
Prospective Registry Study on the Association of Body Composition, Left Atrial Low-Voltage Substrate, and Clinical Outcomes in Patients Undergoing First-Time Catheter Ablation for Atrial Fibrillation
Scientific Title:Acronym
AF-BCAS Registry
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively investigate the association between body composition assessed by InBody, left atrial electrical substrate including low-voltage areas, and clinical outcomes after first-time catheter ablation in patients with atrial fibrillation.
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship among body composition, left atrial electrical substrate, and post-ablation clinical course in patients undergoing catheter ablation for atrial fibrillation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between the proportion or extent of left atrial low-voltage areas on the left atrial voltage map obtained during first-time catheter ablation and pre-procedural body composition parameters assessed by InBody.
Key secondary outcomes
1. Association of atrial fibrillation or atrial tachyarrhythmia recurrence at 1, 3, 6, and 12 months after ablation with pre-procedural body composition parameters, left atrial low-voltage areas, and frailty assessment.
2. Modified EHRA score, use of antiarrhythmic drugs, electrical cardioversion, and repeat ablation at 1, 3, 6, and 12 months after ablation.
3. Association of procedural parameters, including procedure time, energy modality, ablation energy, additional ablation, first-pass isolation, and immediate reconnection, with body composition parameters and left atrial low-voltage areas.
4. Changes in echocardiographic parameters, especially left atrial strain, before ablation, on the day after ablation, and at 1, 3, 6, and 12 months after ablation, and their association with body composition parameters, left atrial low-voltage areas, and clinical outcomes.
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients scheduled to undergo first-time catheter ablation for atrial fibrillation.
2. Patients who provide written informed consent to participate in this study.
3. Patients aged 20 years or older at the time of informed consent.
Key exclusion criteria
1. Patients who have previously undergone catheter ablation for atrial fibrillation.
2. Patients who do not provide informed consent to participate in this study.
3. Patients judged by the principal investigator or attending physician to be unsuitable for participation in this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Ohta |
Organization
Hokkaido cardiovascular hospital
Division name
Department of cardiology
Zip code
064-8622
Address
Minami 27-jo Nishi 13-chome 1-30, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-563-3911
m-oota@hokujun.or.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ohta |
Organization
Hokkaido cardiovascular hospital
Division name
Department of cardiology
Zip code
064-8622
Address
Minami 27-jo Nishi 13-chome 1-30, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-563-3911
Homepage URL
m-oota@hokujun.or.jp
Sponsor or person
Institute
Hokkaido Cardiovascular Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee, Hokkaido Cardiovascular Hospital
Address
Minami 27-jo Nishi 13-chome 1-30, Chuo-ku, Sapporo, Hokkaido 064-8622, Japan
Tel
011-563-3911
hokujyunncrc1@gmail.com
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
| 2026 | Year | 06 | Month | 03 | 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
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 03 | 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
This is a single-center, prospective observational registry study involving patients undergoing first-time catheter ablation for atrial fibrillation. No study-specific therapeutic intervention or treatment allocation will be performed. Data will be collected from catheter ablation and related examinations performed as part of routine clinical practice. Pre-procedural data will include body composition assessed by InBody, frailty assessment, blood tests, echocardiography, CT findings, left atrial voltage mapping during the procedure, and ablation-related procedural parameters. Follow-up data will be collected at 1, 3, 6, and 12 months after ablation, including arrhythmia recurrence, modified EHRA score, use of antiarrhythmic drugs, electrical cardioversion, and repeat ablation.
Management information
Registered date
| 2026 | Year | 06 | Month | 03 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070647
