UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030433
Receipt No. 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 2019/06/13

* 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
Email 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
Email plus9@med.nagoya-u.ac.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

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
Email 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 No longer recruiting
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
2021 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
2019 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034749

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.