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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024725
Receipt No. R000028448
Scientific Title In-hospital outcome of transcatheter and surgical aortic valve replacement in patients with aortic valve stenosis: results from diagnosis procedure combination (DPC) data in Japan
Date of disclosure of the study information 2016/11/06
Last modified on 2019/02/10

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Basic information
Public title In-hospital outcome of transcatheter and surgical aortic valve replacement in patients with aortic valve stenosis: results from diagnosis procedure combination (DPC) data in Japan
Acronym In-hospital outcome of transcatheter and surgical aortic valve replacement
Scientific Title In-hospital outcome of transcatheter and surgical aortic valve replacement in patients with aortic valve stenosis: results from diagnosis procedure combination (DPC) data in Japan
Scientific Title:Acronym In-hospital outcome of transcatheter and surgical aortic valve replacement
Region
Japan

Condition
Condition aortic valve stenosis
Classification by specialty
Anesthesiology Cardiovascular surgery Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the short term outcome of surgical aortic valve replacement and transcatheter aortic valve.
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 10000

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 +72-804-0100(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 2-3-1 Shin-machi, Hirakata, Osaka 573-1191, Japan
TEL +72-804-0100(56372)
Homepage URL
Email umegakit@hirakata.kmu.ac.jp

Sponsor
Institute Department of Anesthesiology, Kansai Medical University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 11 Month 06 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
Results
This study aimed to compare in-hospital outcomes between TAVI and SAVR using a multi-center administrative database in Japan. TAVI produced better clinical outcomes in patients with aortic valve stenosis. The improved outcomes were particularly notable in patients aged 80 years or older.

Measurements andMainResults: The mainstudyoutcomemeasurewasin-hospitalmortality.Basedonmultiplelogisticregressionanalysis
using inverseprobabilityoftreatmentweighting,theoddsratioofin-hospitalmortalityforTAVI(relativetoSAVR)wascalculatedtobe0.36 (95% confidence intervals:0.13-0.98; p=0.04). Inpatientsaged80yearsorolder,theoddsratiowasevenlowerat0.34(95%confidence intervals: 0.15-0.73;p<0.01). Inaddition,theincidencesofreoperations,hemorrhagiccomplications,cardiactamponade,andpostoperative
infections weresignificantly higherintheSAVRpatients.
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
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective cohort study

Journal of Cardiothoracic and Vascular Anesthesia 2017 32(3):1281-1288

Management information
Registered date
2016 Year 11 Month 05 Day
Last modified on
2019 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028448

Research Plan
Registered date File name
2017/05/08 2017_04_05 修正TAVI AVR研究計画書.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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