UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056827 |
|---|---|
| Receipt number | R000064949 |
| Scientific Title | Prognosis after initial catheter ablation in patients with atrial fibrillation and preserved left ventricular ejection fraction |
| Date of disclosure of the study information | 2025/01/27 |
| Last modified on | 2025/01/27 10:14:28 |
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Basic information
Public title
Prognosis after initial catheter ablation in patients with atrial fibrillation and preserved left ventricular ejection fraction
Acronym
Prognosis after initial catheter ablation in patients with atrial fibrillation and preserved left ventricular ejection fraction
Scientific Title
Prognosis after initial catheter ablation in patients with atrial fibrillation and preserved left ventricular ejection fraction
Scientific Title:Acronym
Prognosis after CA in patients with AF and HFpEF
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Heart failure worsening events
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart failure worsening events
Key secondary 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. People aged 18 years or older at the time of registration (regardless of gender)
2. People who underwent initial catheter ablation for atrial fibrillation at Niigata University Medical and Dental Hospital between January 2017 and December 2022 and had a left ventricular ejection fraction of 50% or more at that time.
Key exclusion criteria
None
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Inomata |
Organization
Niigata University
Division name
Cardiology
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku
TEL
0252272185
inotaka@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Fujiki |
Organization
Niigata University
Division name
Cardiology
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku
TEL
0252272185
Homepage URL
sfujiki@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
Self funding
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
1-757 Asahimachi-dori, Chuo-ku
Tel
025-227-2005
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
| 2025 | Year | 01 | Month | 27 | 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
| 2025 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the clinical course of patients with atrial fibrillation after catheter ablation
Management information
Registered date
| 2025 | Year | 01 | Month | 27 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064949
