UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044943 |
|---|---|
| Receipt number | R000050441 |
| Scientific Title | Histological Evaluation of Atrial Fibrillation Substrate Based on Atrial Septum Biopsy 2 |
| Date of disclosure of the study information | 2021/07/26 |
| Last modified on | 2022/07/20 16:06:36 |
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Basic information
Public title
Histological Evaluation of Atrial Fibrillation Substrate Based on Atrial Septum Biopsy 2
Acronym
HEAL-AF Study 2
Scientific Title
Histological Evaluation of Atrial Fibrillation Substrate Based on Atrial Septum Biopsy 2
Scientific Title:Acronym
HEAL-AF Study 2
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the relationship between histological findings based on atrial biopsy and outcomes at 3 years post-atrial fibrillation ablation
Basic objectives2
Others
Basic objectives -Others
Histological evaluation of biopsy samples from the right atrium in patients with atrial fibrillation
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between histological findings based on atrial biopsy and outcomes at 3 years post-atrial fibrillation ablation
Key secondary outcomes
Histological evaluation of biopsy samples from the right atrium in patients with atrial fibrillation
Relationship between histological and electrophysiological findings
Relationship between histological findings and clinical factors
Relationship between histological findings and gene expression
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
1) Patients undergoing catheter ablation for atrial fibrillation between January 2021 and December 2022
2) Patients over 20 years old
Key exclusion criteria
1) Patients who are pregnant or who may become pregnant
2) Patients with thrombus in the left atrium
3) Other patients who are judged by the attending physician to be unable to participate in the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | TAKANORI |
| Middle name | |
| Last name | YAMAGUCHI |
Organization
Saga University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
849-8501
Address
5-1-1Nabeshima,Saga
TEL
0952342443
takanori@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKANORI |
| Middle name | |
| Last name | YAMAGUCHI |
Organization
Saga University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
849-8501
Address
5-1-1Nabeshima,Saga
TEL
0952342443
Homepage URL
takanori@cc.saga-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Saga University
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, 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
5-1-1Nabeshima,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
大分大学医学部循環器内科・臨床検査診断学講座（大分）
東京大学医学部附属病院循環器内科（東京）
理化学研究所生命医科学研究センター（神奈川）
国立長寿医療研究センター（愛知）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2025 | 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. Echocardiography and blood tests will also be performed at 12 and 36 months post-ablation.
Management information
Registered date
| 2021 | Year | 07 | Month | 23 | Day |
Last modified on
| 2022 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050441
