UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056498 |
|---|---|
| Receipt number | R000064564 |
| Scientific Title | A multicenter Study of the Current Status of Maze Surgery and the Optimal Line of Ablation for Atrial Fibrillation in Japan |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2025/01/05 16:14:38 |
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Basic information
Public title
A multicenter Study of the Current Status of Maze Surgery and the Optimal Line of Ablation for Atrial Fibrillation in Japan
Acronym
A multicenter Study of the Current Status of Maze Surgery and the Optimal Line of Ablation for Atrial Fibrillation in Japan
Scientific Title
A multicenter Study of the Current Status of Maze Surgery and the Optimal Line of Ablation for Atrial Fibrillation in Japan
Scientific Title:Acronym
A multicenter Study of the Current Status of Maze Surgery and the Optimal Line of Ablation for Atrial Fibrillation in Japan
Region
| Japan |
Condition
Condition
Patients who underwent surgical atrial fibrillation surgery (Maze procedure) in 2002 at our institution and at the institutions participating in this study.
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this multicenter study is to investigate the current status of Maze surgery in Japan and to clarify the background and indications of patients undergoing Maze surgery, the details of Maze surgery procedures (especially the cautery line) performed, and the results of these procedures. Subsequently, the study will provide information that will enable surgeons to clearly identify the indications for Maze surgery by identifying the group of patients who can be defibrillated at a high rate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify risk factors for atrial fibrillation recurrence based on the rate of atrial fibrillation avoidance in the first postoperative year.
Key secondary outcomes
To identify risk factors for the development of postoperative complications such as the presence or absence of stroke, pacemaker implantation rate, and the development of refractory postoperative supraventricular arrhythmias.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent maze surgery for atrial fibrillation at each institution in 2022.
Key exclusion criteria
none
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yamaguchi |
| Middle name | |
| Last name | Hiroki |
Organization
Showa-university Koto-toyosu Hospital
Division name
Department of cardiovascular surgery
Zip code
135-8577
Address
Toyosu 5-1-38, Koto-ku, Tokyo, Japan
TEL
03-6204-6000
hyamaguchi@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Nakamura |
| Middle name | |
| Last name | Hiromasa |
Organization
Showa-university Koto-toyosu Hospital
Division name
Department of cardiovascular suregry
Zip code
135-8577
Address
Toyosu 5-1-38, Koto-ku, Tokyo, Japan
TEL
09082843959
Homepage URL
kinakamurah@gmail.com
Sponsor or person
Institute
Showa-university Koto-toyosu Hospital, Department of cardiovascular surgery
Institute
Department
Personal name
Funding Source
Organization
Medtronic co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Center for Supervision and Research Promotion
Address
3F, Building 1, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8000
surac1@ofc.showa-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 | 06 | 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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 25 | 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
To determine the details of maze surgeries performed at each institution in 2022. The questionnaire will focus on the background and indications of patients who underwent maze surgery at each institution, details of the maze surgery procedure performed, and especially the ablation line. Information will also be collected on the presence or absence of defibrillation, postoperative complications of supraventricular arrhythmias, and occurrence of stroke.
Management information
Registered date
| 2024 | Year | 12 | Month | 19 | Day |
Last modified on
| 2025 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064564
