UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048336 |
|---|---|
| Receipt number | R000055095 |
| Scientific Title | Impact of High Implantation of Transcatheter Heart Valve during Transcatheter Aortic Valve Replacement on Future Coronary Access |
| Date of disclosure of the study information | 2022/07/12 |
| Last modified on | 2022/07/11 16:27:53 |
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Basic information
Public title
Impact of High Implantation of Transcatheter Heart Valve during Transcatheter Aortic Valve Replacement on Future Coronary Access
Acronym
Impact of High Implantation of Transcatheter Heart Valve during Transcatheter Aortic Valve Replacement on Future Coronary Access
Scientific Title
Impact of High Implantation of Transcatheter Heart Valve during Transcatheter Aortic Valve Replacement on Future Coronary Access
Scientific Title:Acronym
Impact of High Implantation of Transcatheter Heart Valve during Transcatheter Aortic Valve Replacement on Future Coronary Access
Region
| Japan |
Condition
Condition
severe aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the impact of high Implantation of transcatheter heart valve during transcatheter aortic valve replacement on future coronary access
Basic objectives2
Others
Basic objectives -Others
To assess the impact of high Implantation of transcatheter heart valve during transcatheter aortic valve replacement on conduction disturbances
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of computed tomography-identified unfavorable coronary access after transcatheter aortic valve replacement
Key secondary outcomes
The 30-day new pacemaker implantation and new-onset left bundle branch block after transcatheter aortic valve replacement
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with severe aortic stenosis who underwent transcatheter aortic valve replacement from October 2013
Key exclusion criteria
Patients who did not undergo electrocardiography-gated contrast-enhanced post-transcatheter aortic valve replacement computed tomography or whose computed tomography image quality was poor, or those who underwent valve-in-valve implantation
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Ochiai |
Organization
Shonan Kamakura General Hospital
Division name
Department of Cardiology
Zip code
2478533
Address
1370-1, Okamoto, Kamakura, Kanagawa 2478533, JAPAN
TEL
0467461717
tomoki.ochiai.0307@gmail.com
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Ochiai |
Organization
Shonan Kamakura General Hospital
Division name
Department of Cardiology
Zip code
2478533
Address
1370-1, Okamoto, Kamakura, Kanagawa 2478533, JAPAN
TEL
0467461717
Homepage URL
tomoki.ochiai.0307@gmail.com
Sponsor or person
Institute
Department of Cardiology, Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Kamakura General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Tokushukai Group Ethics Committee
Address
Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, JAPAN
Tel
0332634801
mirai-ec1@mirai-iryo.com
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
湘南鎌倉総合病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 12 | 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
800
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
| 2022 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2022 | Year | 07 | Month | 11 | Day |
Last modified on
| 2022 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055095
