UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057130 |
|---|---|
| Receipt number | R000065303 |
| Scientific Title | Impact of Straight Ascending Aorta Length about Difficulty of Crossing Aortic Valve during Transcatheter Aortic Valve Replacement |
| Date of disclosure of the study information | 2025/02/27 |
| Last modified on | 2025/08/28 07:22:56 |
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Basic information
Public title
Impact of Straight Ascending Aorta Length about Difficulty of Crossing Aortic Valve during Transcatheter Aortic Valve Replacement
Acronym
Impact of Straight Ascending Aorta Length about Difficulty of Crossing Aortic Valve during Transcatheter Aortic Valve Replacement
Scientific Title
Impact of Straight Ascending Aorta Length about Difficulty of Crossing Aortic Valve during Transcatheter Aortic Valve Replacement
Scientific Title:Acronym
Impact of Straight Ascending Aorta Length about Difficulty of Crossing Aortic Valve during Transcatheter Aortic Valve Replacement
Region
| Japan |
Condition
Condition
Aortic valve stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to focus SAAL features and investigate association with the difficulty of THV device crossing. We also compared the prediction performance with conventional indexes.
Basic objectives2
Others
Basic objectives -Others
Even though there were not conventional risk factors, not large aortic angulation, we experienced some difficult crossing cases, which had short ascending aorta.Short SAAL can cause the THV device to lack the distance required to orient in the direction of the aortic annulus, followed by un-passing aortic valve.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difficulty of TAVR device crossing
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with symptomatic severe AS (aortic valve area (AVA) < 1.0cm2 or indexed AVA < 0.6cm2/m2) treated with TAVR at Shinshu university hospital
Key exclusion criteria
The alternative TAVR case via apex of left ventricle
Target sample size
307
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Saigusa |
Organization
Shinshu university school of medicine
Division name
Department of cardiovascular medicine
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto Nagano Japan
TEL
0263354600
tatsuwan@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Saigusa |
Organization
Shinshu university school of medicine
Division name
Department of cardiovascular medicine
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto Nagano Japan
TEL
09014667670
Homepage URL
tatsuwan@yahoo.co.jp
Sponsor or person
Institute
Shinshu university
Institute
Department
Personal name
Funding Source
Organization
none
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
Shinshu university school of medicine
Address
3-1-1 Asahi Matsumoto Nagano Japan
Tel
0263-35-4600
tatsuwan@yahoo.co.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
| 2025 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
307
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
Main results already published
Date of protocol fixation
| 2025 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective study that included 307 consecutive patients with symptomatic severe AS (aortic valve area (AVA) < 1.0cm2 or indexed AVA < 0.6cm2/m2) treated with TAVR at Shinshu university hospital, Matsumoto, Japan from October 2018 through July 2024. Straight ascending aorta length (SAAL) was defined as the length between the level of virtual basal ring and that of lesser curvature at the aortic arch. We hypothesized that SAAL may be a more predictable index of THV device crossing difficulty than conventional indexes.
Management information
Registered date
| 2025 | Year | 02 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065303
