UMIN-CTR Clinical Trial

Basic information
Public title	Left Atrial appendage closure: Compare with AtriClip vs Appendage resection
Acronym	Left Atrial appendage closure: Compare with AtriClip vs Appendage resection
Scientific Title	Left Atrial appendage closure: Compare with AtriClip vs Appendage resection
Scientific Title:Acronym	Compare with AtriClip vs Appendage resection
Region	Japan

Condition
Condition	Atrial fiblliation cardiacsurgery left appendage operation
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	we compare the residual left atrial appendage lumen (stump formation) between epicardial clip (AtriClip) and appendage resection, and the early and mid-term results of each technique.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	stroke incidents caused by cardiogenic thrombus
Key secondary outcomes	reoperation or death.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	AtriClip Resection
Key exclusion criteria	ligation internal suture closure
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Ken Middle name Last name Nakamura
Organization	Saitama Cardiovascular and Respiratory Center
Division name	Cardiac surgery
Zip code	360-0197
Address	1696,Itai
TEL	+81485369900
Email	cardiacsurgken@ybb.ne.jp

Public contact
Name of contact person	1st name Ken Middle name Last name Nakamura
Organization	Saitama Cardiovascular and Respiratory Center
Division name	Cardiac surgery
Zip code	360-0197
Address	1696, Itai, Kumagayashi,Saitama
TEL	0485369900
Homepage URL
Email	cardiacsurgken@ybb.ne.jp

Sponsor
Institute	Saitama Cardiovascular and Respiratory Center
Institute
Department

Funding Source
Organization	Saitama Cardiovascular and Respiratory Center
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the institutional review board at the Saitama Cardiovascular and Respiratory Center (No. 2021032).
Address	169, Itai, Kumagayashi,Saitama
Tel	+81485369900
Email	cardiacsurgken@ybb.ne.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 12 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	Open public recruiting
Date of protocol fixation	2018 Year 01 Month 01 Day
Date of IRB	2021 Year 10 Month 06 Day
Anticipated trial start date	2018 Year 01 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing

Management information
Registered date	2021 Year 10 Month 28 Day
Last modified on	2021 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052392