UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053644 |
|---|---|
| Receipt number | R000061220 |
| Scientific Title | Prospective observational study on multidimensional analysis of atrial function and prognosis after ablation therapy in patients with atrial fibrillation |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2025/02/24 11:08:36 |
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Basic information
Public title
Prospective observational study on multidimensional analysis of atrial function and prognosis after ablation therapy in patients with atrial fibrillation
Acronym
Prospective observational study on multidimensional analysis of atrial function and prognosis after ablation therapy in patients with atrial fibrillation
Scientific Title
Prospective observational study on multidimensional analysis of atrial function and prognosis after ablation therapy in patients with atrial fibrillation
Scientific Title:Acronym
Prospective observational study on multidimensional analysis of atrial function and prognosis after ablation therapy in patients with atrial fibrillation
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will evaluate and observe the left atrium from multiple perspectives, including "volume," "wall motion," "pressure," "voltage," and "neurohumoral factors," in patients undergoing catheter ablation for atrial fibrillation. By following patients long-term and investigating the association with outcomes, we aim to contribute to the selection of appropriate atrial fibrillation ablation patients, estimation of prognosis, and establishment of follow-up methods.
Basic objectives2
Others
Basic objectives -Others
It is unclear which patients with atrial fibrillation will benefit from ablation therapy, as well as the changes in atrial function after ablation and its association with clinical outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relation between left atrial strain and QOL score at 6, 12, 24, and 36 months after ablation and data measured at the time of ablation
Key secondary outcomes
The relations between the cardiovascular events indicated below and data measured at the time of ablation.
A. total death
B. systemic embolism
C. major bleeding
D. hospitalization due to cardiovascular events including heart failure
E. recurrence of atrial fibrillation
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who will undergo catheter ablation for atrial fibrillation.
Key exclusion criteria
Patients who may have difficulty undergoing routine testing after ablation
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Hasegawa |
Organization
Niigata University, Graduate School of Medical and Dental Sciences.
Division name
Department of Cardiovascular Medicine
Zip code
951-8510
Address
757 ichiban-cho, asahimachi-dori, chuo-ku, niigata 951-8510 Japan.
TEL
025-227-2185
yukihasegawa@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Hasegawa |
Organization
Niigata University, Graduate School of Medical and Dental Sciences.
Division name
Department of Cardiovascular Medicine
Zip code
951-8510
Address
757 ichiban-cho, asahimachi-dori, chuo-ku, niigata 951-8510 Japan.
TEL
025-227-2185
Homepage URL
yukihasegawa@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata 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
Ethics Committee of Niigata University
Address
757 ichiban-cho, asahimachi-dori, chuo-ku, niigata
Tel
025-227-2625
ethics@adm.niigata-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
| 2024 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Not analyzed
Management information
Registered date
| 2024 | Year | 02 | Month | 19 | Day |
Last modified on
| 2025 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061220
