UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of intracardiac echocardiography monitoring during transcatheter aortic valve implantation procedure
Title of the study (Brief title)	Efficacy of ICE during TAVI procedure
Region	Japan

Condition
Condition	severe aortic stenosis
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We compare the efficacy of monitoring between transesophageal echocardiography and intra-cardiac echocardiography during TAVI procedure under general anesthesia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	qualitative examination of complications below: para-valvular leakage, mitral regurgitation, rupture of aortic annulus, contained rupture in ascending aorta, aortic dissection, coronary artery occlusion, myocardial rupture, pericardial effusion, and myocardial infarction
Key secondary outcomes	morphological and hemodynamic assessment below around aortic valve: annulus size, valsalva size, STJ size, ascending aorta size, aortic valve area, number of leaflet, peal and mean aortic valve blood flow velocity and pressure gradient

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	Patients who undergo TAVI operation in Teikyo university hospital
Key exclusion criteria	Patients who do not have appropriate approach in the vein or heart Patients from whom we cannot obtain the concent of this study
Target sample size	50

Research contact person
Name of lead principal investigator	Akihisa Kataoka
Organization	Teikyo University Hospital
Division name	Division of Cardiology
Address	2-11-1 Kaga, Itabashi-ku, Tokyo
TEL	03-3964-1211(30418)
Email	kataoaki@sd5.so-net.ne.jp

Public contact
Name of contact person	Akihisa Kataoka
Organization	Teikyo University Hospital
Division name	Division of Cardiology
Address	2-11-1 Kaga, Itabashi-ku, Tokyo
TEL	03-3964-1211(30418)
Homepage URL
Email	kataoaki@sd5.so-net.ne.jp

Sponsor
Institute	Teikyo University Hospital
Institute
Department

Funding Source
Organization	Teikyo University Hospital
Organization
Division
Category of Funding Organization	Self funding
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	帝京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 16 Day
Anticipated trial start date	2015 Year 10 Month 16 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	Study design: Observation study Object recruitment: All patients who admitted in Teikyo university hospital and meet the selection criteria from October 2015 to September 2017. Parameter measurement: #1 qualitative examination of complications below para-valvular leakage, mitral regurgitation, rupture of aortic annulus, contained rupture in ascending aorta, aortic dissection, coronary artery occlusion, myocardial rupture, pericardial effusion, and myocardial infarction #2 morphological and hemodynamic assessment below around aortic valve annulus size, valsalva size, STJ size, ascending aorta size, aortic valve area, number of leaflet, peal and mean aortic valve blood flow velocity and pressure gradient

Management information
Registered date	2015 Year 11 Month 08 Day
Last modified on	2018 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022184