UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019678 |
|---|---|
| Receipt number | 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 12:02:53 |
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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)
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
kataoaki@sd5.so-net.ne.jp
Sponsor or person
Institute
Teikyo University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022184
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
