UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045894
Receipt number R000052392
Scientific Title Left Atrial appendage closure: Compare with AtriClip vs Appendage resection
Date of disclosure of the study information 2021/12/01
Last modified on 2021/10/28 10:58:17

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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 or person

Institute

Saitama Cardiovascular and Respiratory Center

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052392


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name