UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030433 |
|---|---|
| Receipt number | R000034749 |
| Scientific Title | Med-term postoperative outcomes due to differences in measurement of aortic annulus by transesophageal echocardiography and computed tomography in transcatheter aortic valve implantation |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2021/01/07 14:12:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Med-term postoperative outcomes due to differences in measurement of aortic annulus by transesophageal echocardiography and computed tomography in transcatheter aortic valve implantation
Acronym
Med-term postoperative outcomes due to differences in measurement of aortic annulus by 3D-TEE and MDCT in TAVI
Scientific Title
Med-term postoperative outcomes due to differences in measurement of aortic annulus by transesophageal echocardiography and computed tomography in transcatheter aortic valve implantation
Scientific Title:Acronym
Med-term postoperative outcomes due to differences in measurement of aortic annulus by 3D-TEE and MDCT in TAVI
Region
| Japan |
Condition
Condition
Transcatheteric aortic valve implantation (TAVI)
Transcatheter aortic valve replacement (TAVR)
Classification by specialty
| Cardiology | Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The mid-term outocmes of perivalvar regurgitation after TAVI due to differences in aortic annulus measurement methods (3D-TEE vs. MDCT) were investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mid-term progression of perivalvar regurgitation after TAVI due to differences in aortic annulus measurement method (3D-TEE vs. MDCT)
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
Patients undergone TAVI (TAVR) from January 2015 to December 2018
Patients with more than 20 years old
Key exclusion criteria
emergency operation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Ohnishi |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Anesthesiology
Zip code
565-8565
Address
5-7-1 fujishirodai, Suita, Osaka, Japan
TEL
06-6833-5012
yonishi@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Tasuku |
| Middle name | |
| Last name | Fujii |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Anesthesiology
Zip code
565-8565
Address
5-7-1 fujishirodai, Suita, Osaka, Japan
TEL
06-6833-5012
Homepage URL
plus9@med.nagoya-u.ac.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
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
National Cerebral and Cardiovascular Center
Address
5-7-1 Fujishiro-dai, Suita, Osaka, Japan
Tel
06-6833-5012
plus9@med.nagoya-u.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 | 03 | Month | 01 | 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
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 | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective singlecenter study
Management information
Registered date
| 2017 | Year | 12 | Month | 17 | Day |
Last modified on
| 2021 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034749
