UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052706