UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050346 |
|---|---|
| Receipt number | R000056559 |
| Scientific Title | Esophageal complications from atrial fibrillation ablation |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2023/02/15 12:14:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Esophageal complications from atrial fibrillation ablation
Acronym
Esophageal complications from atrial fibrillation ablation
Scientific Title
Esophageal complications from atrial fibrillation ablation
Scientific Title:Acronym
Esophageal complications from atrial fibrillation ablation
Region
| Japan |
Condition
Condition
Atrial Fibrillation/ tachycardia, Esophageal complication
Classification by specialty
| Gastroenterology | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The rate of esophageal complication during ablation of AF and AT
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
esophageal complication (erythema/erosion, ulcer, perforation)
Key secondary outcomes
time course of complication
recurrence rate of AF or AT
rate of the complication other than esophagus
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Perform upper gastrointestinal endoscopy after ablation
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 ablation for atrial fibrillation/tachycardia
2. patients who are 20 years of age or older at the time of consent
3. patients who have given their free written consent to participate in this study
Key exclusion criteria
1. patients deemed by the investigator to be inappropriate for participation in the study
2. patients with contraindications to upper gastrointestinal endoscopy (e.g. patients with allergies to pharyngeal anesthetics that preclude their use)
3. patients with a history of upper gastrointestinal disease prior to ablation
4. patients who have difficulty understanding the study in the investigator's judgment
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Fukuzawa |
Organization
Kobe University Graduate School of Medicine
Division name
Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
Kusunoki-Cho 7-5-2, Chuoh-Ku, Kobe, Japan
TEL
+81783825846
kfuku@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Murakami |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
Kusunoki-Cho 7-5-2, Chuoh-Ku, Kobe, Japan
TEL
+81783825846
Homepage URL
mura0649@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
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
Kobe University Hospital Clinical and Translational Research Center
Address
Kusunoki-Cho 7-5-2, Chuoh-Ku, Kobe, Japan
Tel
078-382-6669
kainyu@med.kobe-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
| 2023 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 15 | Day |
Last modified on
| 2023 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056559
