UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059261 |
|---|---|
| Receipt number | R000067732 |
| Scientific Title | Histological Evaluation of Atrial Fibrillation Substrate Based on Atrial Septum Biopsy 3 |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/10/01 18:32:37 |
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Basic information
Public title
Histological Evaluation of Atrial Fibrillation Substrate Based on Atrial Septum Biopsy 3
Acronym
HEAL-AF Study 3
Scientific Title
Histological Evaluation of Atrial Fibrillation Substrate Based on Atrial Septum Biopsy 3
Scientific Title:Acronym
HEAL-AF Study 3
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess temporal changes in atrial histology through a second atrial biopsy and to elucidate their association with post-ablation recurrence.
Basic objectives2
Others
Basic objectives -Others
To elucidate the mechanisms of atrial fibrillation by integrating histological, biochemical, and electrophysiological evaluations, with a focus on temporal changes.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between temporal histopathological changes and recurrence post-ablation
Key secondary outcomes
Relationship between histological findings and cardiovascular outcomes
Associations between blood biomarkers and histological findings
Associations between gene expression profiles and histological findings
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible patients are those who meet all of the following criteria:
1. Patients undergoing radiofrequency catheter ablation for recurrent atrial fibrillation or macroreentrant atrial tachycardia during the period from the date of issuance of the administrative approval notice until December 31, 2025.
2. Patients who previously participated in the HEAL-AF study, HEAL-AF2 study, or FUTURE-AF-S study, and who underwent atrial biopsy at the time of the prior ablation.
3. Age 20 years or older.
Key exclusion criteria
Exclusion Criteria
1. Pregnant patients or those with the possibility of pregnancy.
2. Patients with evidence of left atrial thrombus.
3. Patients deemed unsuitable for study participation by the attending physician.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | TAKANORI |
| Middle name | |
| Last name | YAMAGUCHI |
Organization
Saga University
Division name
Department of Cardiovascular Medicine
Zip code
8498501
Address
5-1-1 Nabeshuna,Saga
TEL
0952342364
takanori@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKANORI |
| Middle name | |
| Last name | YAMAGUCHI |
Organization
Saga University
Division name
Department of Cardiovascular Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga
TEL
0952342364
Homepage URL
takanori@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Saga University
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
CLINICAL RESEARCH CENTER, SAGA UNIVERSITY HOSPITAL
Address
5-1-1 Nabeshima, Saga
Tel
0952343400
kenkyu-shinsei@ml.cc.saga-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 | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 11 | 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
Recurrence of atrial tachyarrhythmias and cardiovascular events will be evaluated at 3, 6, 12, 24, and 36 months after ablation.
Management information
Registered date
| 2025 | Year | 10 | Month | 01 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067732
