UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	respiratory function after transcatherter aortic valve implantation
Title of the study (Brief title)	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	Yuko Furuichi
Organization	Sakakibara heart Institute
Division name	Dept of Anesthesiology
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	Yuko Furuichi
Organization	Sakakibara heart Institute
Division name	Dept of Anesthesiology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 06 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000035301