UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046176 |
|---|---|
| Receipt number | R000052706 |
| Scientific Title | The association between early atrial tachyarrhythmia recurrence and late atrial tachyarrhythmia recurrence after modified cryo-Maze procedure. |
| Date of disclosure of the study information | 2021/11/25 |
| Last modified on | 2022/11/26 17:09:51 |
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Basic information
Public title
The association between early atrial tachyarrhythmia recurrence and late atrial tachyarrhythmia recurrence after modified cryo-Maze procedure.
Acronym
The association between early atrial tachyarrhythmia recurrence and late atrial tachyarrhythmia recurrence after modified cryo-Maze procedure.
Scientific Title
The association between early atrial tachyarrhythmia recurrence and late atrial tachyarrhythmia recurrence after modified cryo-Maze procedure.
Scientific Title:Acronym
The association between early atrial tachyarrhythmia recurrence and late atrial tachyarrhythmia recurrence after modified cryo-Maze procedure.
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology | Surgery in general | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the association between early atrial tachyarrhythmia recurrence and late atrial tachyarrhythmia recurrence after modified cryo-Maze procedure.
Basic objectives2
Others
Basic objectives -Others
Investigate the association between early atrial tachyarrhythmia recurrence and late atrial tachyarrhythmia recurrence after modified cryo-Maze procedure.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative late atrial tachyarrhythmia recurrence including atrial fibrillation and/or atrial flutter and/or supraventricular tachycardia.
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 undergoing modified cryo-Maze procedure.
Key exclusion criteria
None
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | kimito |
| Middle name | Minami |
| Last name | Minami |
Organization
National cerebral and cardiovascular center
Division name
Department of Surgical Intensive Care
Zip code
564-8565
Address
6-1Kishibeshinmachi, Suita, Osaka
TEL
0661701070
k.minami@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Kimito |
| Middle name | Minami |
| Last name | Minami |
Organization
National cerebral and cardiovascular center
Division name
Department of surgical intensive care
Zip code
564-8565
Address
6-1Kishibeshinmachi, Suita, Osaka
TEL
0661701070
Homepage URL
k.minami@ncvc.go.jp
Sponsor or person
Institute
National cerebral and cardiovascular center
Institute
Department
Personal name
Funding Source
Organization
National cerebral and cardiovascular center
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
National cerebral and cardiovascular center
Address
6-1Kishibeshinmachi, Suita, Osaka
Tel
0661701070
k.minami@ncvc.go.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
| 2021 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
610
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
Main results already published
Date of protocol fixation
| 2018 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the association between early atrial tachyarrhythmia (ATA) recurrence and late ATA recurrence among patients undergoing modified cryo-Maze procedure, multivariable Cox proportional regression was used. Late ATA recurrence is dealt as repeated measured outcome. Outcome was adjusted by age, gender, body surface area, preoperative duration of atrial fibrillation, left atrial diameter, and concomitant valve surgery. Missing data were analyzed by multiple imputation.
Management information
Registered date
| 2021 | Year | 11 | Month | 25 | Day |
Last modified on
| 2022 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052706
