UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060583 |
|---|---|
| Receipt number | R000069267 |
| Scientific Title | Gastroesophageal Reflux and AF Recurrence After Ablation |
| Date of disclosure of the study information | 2026/02/05 |
| Last modified on | 2026/02/05 10:45:02 |
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Basic information
Public title
Gastroesophageal Reflux and AF Recurrence After Ablation
Acronym
AF and GERD
Scientific Title
Gastroesophageal Reflux and AF Recurrence After Ablation
Scientific Title:Acronym
AF and GERD
Region
| Japan |
Condition
Condition
Atrial Fibrillation
Classification by specialty
| Gastroenterology | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to exploratorily evaluate the association between atrial fibrillation ablation and gastroesophageal reflux disease.
Basic objectives2
Others
Basic objectives -Others
To descriptively summarize gastrointestinal-related findings after atrial fibrillation ablation and to exploratorily examine their association with gastroesophageal reflux disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is changes in esophageal-related findings after atrial fibrillation ablation.
The secondary outcome is atrial fibrillation recurrence, recorded based on routine clinical practice.
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
Patients scheduled to undergo catheter ablation for atrial fibrillation (AF).
Patients aged 18 years or older at the time of informed consent.
Patients who have provided written informed consent to participate in the study.
Key exclusion criteria
1) Patients with any of the following diseases:
Esophageal cancer
Pharyngeal cancer
Gastric cancer
Esophageal varices
2) Patients with any of the following conditions:
Esophageal stricture
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Miki |
Organization
Shimane University Hospital
Division name
Division of cardiology
Zip code
693-8501
Address
89-1 Enya-cho, Izumo-shi, Shimane, 693-8501, Japan
TEL
0853232111
mikiyuko1011@gmail.com
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Nagira |
Organization
Shimane University Hospital
Division name
Division of cardiology
Zip code
693-8501
Address
89-1 Enya-cho, Izumo-shi, Shimane, 693-8501, Japan
TEL
0853232111
Homepage URL
yumina@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane university
Institute
Department
Personal name
Funding Source
Organization
Self-funded
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
Shimane university hospital
Address
89-1 Enya-cho, Izumo-shi, Shimane, 693-8501, Japan
Tel
0853202515
kenkyu@med.shimane-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
群馬県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 05 | 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
| 2025 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To descriptively summarize gastrointestinal-related findings after atrial fibrillation ablation and to exploratorily examine their association with gastroesophageal reflux disease.
Management information
Registered date
| 2026 | Year | 02 | Month | 04 | Day |
Last modified on
| 2026 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069267
