UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024725 |
|---|---|
| Receipt number | 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 15:04:26 |
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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)
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
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028448
