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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046176
Receipt No. 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 2021/11/25

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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
Email 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
Email k.minami@ncvc.go.jp

Sponsor
Institute National cerebral and cardiovascular center
Institute
Department

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
Email 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 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 Enrolling by invitation
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
2021 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052706

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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