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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019678
Receipt No. R000022184
Scientific Title Efficacy of intracardiac echocardiography monitoring during transcatheter aortic valve implantation procedure
Date of disclosure of the study information 2015/11/11
Last modified on 2018/05/11

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Basic information
Public title Efficacy of intracardiac echocardiography monitoring during transcatheter aortic valve implantation procedure
Acronym Efficacy of ICE during TAVI procedure
Scientific Title Efficacy of intracardiac echocardiography monitoring during transcatheter aortic valve implantation procedure
Scientific Title:Acronym 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
1st name
Middle name
Last name Akihisa Kataoka
Organization Teikyo University Hospital
Division name Division of Cardiology
Zip code
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
1st name
Middle name
Last name Akihisa Kataoka
Organization Teikyo University Hospital
Division name Division of Cardiology
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2015 Year 09 Month 16 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000022184

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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