UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022704
Receipt number R000026163
Scientific Title Volume-outcome relationships in surgical aortic valve replacement and transcatheter aortic valve implantation in aortic valve stenosis
Date of disclosure of the study information 2016/06/12
Last modified on 2019/02/10 14:54:10

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Basic information

Public title

Volume-outcome relationships in surgical aortic valve replacement and transcatheter aortic valve implantation in aortic valve stenosis

Acronym

Volume-outcome relationships in surgical aortic valve replacement and transcatheter aortic valve implantation

Scientific Title

Volume-outcome relationships in surgical aortic valve replacement and transcatheter aortic valve implantation in aortic valve stenosis

Scientific Title:Acronym

Volume-outcome relationships in surgical aortic valve replacement and transcatheter aortic valve implantation

Region

Japan


Condition

Condition

aortic valve stenosis

Classification by specialty

Anesthesiology Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate association between surgical aortic valve replacement volume and outcomes, and transcatheter aortic valve implantation volume and outcomes.

Basic objectives2

Others

Basic objectives -Others

epidemiology

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Hospital mortality

Key secondary outcomes

28 day mortality


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

adult patients who had aortic valve replacement or transcatheter aortic valve implantation for aortic valve stenosis from April 1, 2012 to March 31, 2016

Key exclusion criteria

under 20 years of age at admission

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Umegaki

Organization

Kansai Medical University Hospital

Division name

Department of Anesthesiology

Zip code


Address

Department of Anesthesiology, Kansai Medical University Hirakata Hospital, 2-3-1 Shin-machi, Hirakata, Osaka 573-1191, Japan

TEL

072-804-0100(56372)

Email

umegakit@hirakata.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Umegaki

Organization

Kansai Medical University Hospital

Division name

Department of Anesthesiology

Zip code


Address

Department of Anesthesiology, Kansai Medical University Hospital, 2-3-1 Shin-machi, Hirakata city

TEL

072-804-0100(56372)

Homepage URL

http://www7.kmu.ac.jp/anesthw/AS.html

Email

umegakit@hirakata.kmu.ac.jp


Sponsor or person

Institute

Department of Anesthesiology, Kansai Medical University Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Healthcare Economics and Quality Management, Kyoto University Graduate School of Medicine

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2016 Year 06 Month 12 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.imedpub.com/heart-and-cardiovascular-research/

Number of participants that the trial has enrolled


Results

This study aimed to assess between isolated surgical aortic valve replacement (SAVR) and mortality in patients with aortic valve stenosis using a large-scale study conducted in Japan. Higher hospital volume was significantly associated with reduced mortality, and patients with aortic valve stenosis may benefit from care in high-volume hospitals.

Results: The low-volume group, intermediate-volume group, and high-volume group comprised 7383 patients from 330 hospitals, 5253 patients from 76 hospitals, and 3411 patients from 23 hospitals, respectively. The regression analysis accounted for patient sex, height, weight, activities of daily living, and comorbidities as covariates. Relative to the intermediate-volume group, the odds ratios for in-hospital mortality were 1.32 (95% confidence intervals: 1.07-1.61; P<0.01) in the low-volume group and 0.65 (0.48-0.87; P<0.01) in the high-volume group.
Conclusion: Higher hospital volume was significantly associated with reduced mortality, and patients with aortic valve stenosis may benefit from care in high-volume hospitals.

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

Completed

Date of protocol fixation

2010 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

retrospective cohort study


Management information

Registered date

2016 Year 06 Month 12 Day

Last modified on

2019 Year 02 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026163


Research Plan
Registered date File name
2017/05/08 2017_04_26 研究計画書 AVRとTAVI Volume Outcome.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name