UMIN-CTR Clinical Trial

Basic information
Public title	Epidemiological study on anesthesia management and circulation management in TAVI (Transcatheter Aortic Valve Implantation)
Acronym	Epidemiological study on anesthesia management and circulation management in TAVI
Scientific Title	Epidemiological study on anesthesia management and circulation management in TAVI (Transcatheter Aortic Valve Implantation)
Scientific Title:Acronym	Epidemiological study on anesthesia management and circulation management in TAVI
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 purpose of this research is to investigate and examine TAVI patients background, type of operation, perioperative cardiac function, circulation condition in the operation, perioperative complication, prognosis.
Basic objectives2	Others
Basic objectives -Others	It is anticipated that TAVI is applied not only to aortic valve stenosis but also to elderly patients and other serious complications in many cases. The importance of anesthesia management and circulation management during the TAVI operation is unclear.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Post operative delirium
Key secondary outcomes

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	AS patients
Key exclusion criteria	No
Target sample size	80

Research contact person
Last name of lead principal investigator	1st name Toshihiro Middle name Last name Wagatsuma
Organization	Tohoku University
Division name	Department of Anesthesiology and Intensive Care
Zip code	9813205
Address	1-1, Seiryo-Machi, Aoba-ku, Sendai-shi, Miyagi-ken, Japan
TEL	0227177321
Email	t-waga@umin.ac.jp

Public contact
1st name of contact person	1st name Toshihiro Middle name Last name Wagatsuma
Organization	Tohoku University
Division name	Department of Anesthesiology and Intensive Care
Zip code	9813205
Address	1-1, Seiryo-Machi, Aoba-ku, Sendai-shi, Miyagi-ken, Japan
TEL	0227177321
Homepage URL
Email	t-waga@umin.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Self founding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tohoku University
Address	1-1, Seiryo-Machi, Aoba-ku, Sendai-shi, Miyagi-ken, Japan
Tel	022-728-4105
Email	http://www.nrs.hosp.tohoku.ac.jp

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 06 Month 18 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	80
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	Completed
Date of protocol fixation	2018 Year 06 Month 18 Day
Date of IRB	2018 Year 06 Month 21 Day
Anticipated trial start date	2018 Year 06 Month 18 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Preinitiation

Management information
Registered date	2018 Year 05 Month 30 Day
Last modified on	2019 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037361