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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030915
Receipt No. R000035301
Scientific Title respiratory function after transcatherter aortic valve implantation
Date of disclosure of the study information 2018/01/21
Last modified on 2018/07/23

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Basic information
Public title respiratory function after transcatherter aortic valve implantation
Acronym respiratory function after TAVI
Scientific Title respiratory function after transcatherter aortic valve implantation
Scientific Title:Acronym respiratory function after TAVI
Region
Japan

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

Objectives
Narrative objectives1 to investigate respiratory function early stage after TAVI
Basic objectives2 Others
Basic objectives -Others to investigate factors that influence respiratory function after TAVI
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes respiratory function from postoperative day to one week after TAVI
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 to implement respiratory function test
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients undergoing TAVI(with out tracheal intubation) from June 2017 to March 2019 at Sakakibara Heart Institute
Key exclusion criteria informed consent was not obtained, emergent TAVI, ventilated, NYHA4, administerd inotropic agents, registered to other trial, difficult to undergoing respiratory function test.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Furuichi
Organization Sakakibara heart Institute
Division name Dept of Anesthesiology
Zip code
Address 3-16-1, Asahi-cho, Fuchu-shi, Tokyo, Japan
TEL 042-314-3111
Email yukof@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Furuichi
Organization Sakakibara heart Institute
Division name Dept of Anesthesiology
Zip code
Address 3-16-1, Asahi-cho, Fuchu-shi, Tokyo, Japan
TEL 042-314-3111
Homepage URL
Email yukof@nms.ac.jp

Sponsor
Institute Sakakibara heart Institute
Institute
Department

Funding Source
Organization Sakakibara heart Institute
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
2018 Year 01 Month 21 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2018 Year 03 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 21 Day
Last modified on
2018 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035301

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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