UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057921 |
|---|---|
| Receipt number | R000066118 |
| Scientific Title | Mid-term clinical outcomes following SAPIEN 3 20-mm transcatheter aortic valve implantation in patients with symptomatic severe aortic valve stenosis. |
| Date of disclosure of the study information | 2025/05/23 |
| Last modified on | 2025/05/20 15:46:05 |
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Basic information
Public title
Mid-term clinical outcomes following SAPIEN 3 20-mm transcatheter aortic valve implantation in patients with symptomatic severe aortic valve stenosis.
Acronym
Mid-term clinical outcomes following SAPIEN 3 20-mm transcatheter aortic valve implantation in patients with symptomatic severe aortic valve stenosis.
Scientific Title
Mid-term clinical outcomes following SAPIEN 3 20-mm transcatheter aortic valve implantation in patients with symptomatic severe aortic valve stenosis.
Scientific Title:Acronym
Mid-term clinical outcomes following SAPIEN 3 20-mm transcatheter aortic valve implantation in patients with symptomatic severe aortic valve stenosis.
Region
| Japan |
Condition
Condition
Aortic valve stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With the progression of the aging population, the number of patients with aortic valve stenosis has been increasing. Transcatheter Aortic Valve Implantation(TAVI) has become an established treatment for the elderly or high-risk surgical patients with symptomatic aortic valve stenosis. The selection of the prosthetic valve size during TAVI is determined based on the annulus diameter and the anatomical characteristics of the aortic valve complex.
Since the aortic annulus in Japanese patients tends to be smaller than that of Western populations, it is often necessary to choose smaller prosthetic valves. However, selecting a smaller valve can result in patient-prosthesis mismatch, which may adversely affect the patients' long-term outcomes.
Therefore, we aimed to evaluate mid-term clinical and echocardiographic outcomes following the implantation of SAPIEN3 20mm transcatheter heart valve in patients with severe aortic valve stenosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We investigated all-cause mortality in patients who underwent transcatheter aortic valve implantation (TAVI) of SAPIEN3 20mm transcatheter heart valve at our institution.
Key secondary outcomes
We investigated cardiovascular mortality, heart failure hospitalization, and echocardiographic data in patients who underwent transcatheter aortic valve implantation (TAVI) of SAPIEN3 20mm transcatheter heart valve at our institution.
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
| 70 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 70 to 100 who underwent transcatheter aortic valve implantation.
Key exclusion criteria
Patients who received self-expanding bioprosthetic valves or underwent transcatheter aortic valve implantation for structural valve degeneration were excluded.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Shunichi |
| Middle name | |
| Last name | Imamura |
Organization
National Hospital Organization Kagoshima Medical Center
Division name
Department of Cardiology
Zip code
892-0853
Address
8-1 Shiroyama-cho, Kagoshima City, Kagoshima Prefecture, 892-0853, Japan
TEL
099-223-1151
www.haruichi.vs.syunichi@gmail.com
Public contact
Name of contact person
| 1st name | Shunichi |
| Middle name | |
| Last name | Imamura |
Organization
National Hospital Organization Kagoshima Medical Center
Division name
Department of Cardiology
Zip code
892-0853
Address
8-1 Shiroyama-cho, Kagoshima City, Kagoshima Prefecture, 892-0853, Japan
TEL
+81-99-223-1151
Homepage URL
www.haruichi.vs.syunichi@gmail.com
Sponsor or person
Institute
National Hospital Organization Kagoshima Medical Center
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
Department of Clinical Research, National Hospital Organization Kagoshima Medical Center
Address
8-1 Shiroyama-cho, Kagoshima City, Kagoshima Prefecture, 892-0853, Japan
Tel
099-223-1151
623-kenkyubu@mail.hosp.go.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 | 05 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2025 | Year | 05 | Month | 20 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066118
