UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058072 |
|---|---|
| Receipt number | R000066104 |
| Scientific Title | Evaluation of the Effectiveness of Transcatheter Valve Therapies from the Perspective of Well-being in Elderly Patients Requiring Long-Term Care or Support |
| Date of disclosure of the study information | 2025/06/09 |
| Last modified on | 2025/06/03 18:42:57 |
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Basic information
Public title
Evaluation of the Effectiveness of Transcatheter Valve Therapies from the Perspective of Well-being in Elderly Patients Requiring Long-Term Care or Support
Acronym
DESIRE Registry (Dependent Elderly Structural heart disease InteREvention Registry)
Scientific Title
Evaluation of the Effectiveness of Transcatheter Valve Therapies from the Perspective of Well-being in Elderly Patients Requiring Long-Term Care or Support
Scientific Title:Acronym
DESIRE Registry (Dependent Elderly Structural heart disease InteREvention Registry)
Region
| Japan |
Condition
Condition
Aortic Stenosis, Mitral Regurgitation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of transcatheter aortic valve implantation (TAVI) and transcatheter edge-to-edge repair (TEER) in elderly patients requiring long-term care or support, focusing on Quality of Life after the procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Unfavorable outcome defined as all-cause mortality or a Kansas City Cardiomyopathy Questionnare (KCCQ) score below 45 or a decline of 10 points or more in KCCQ at one year after the procedure (Valve Academic Research Consortium-3)
Key secondary outcomes
1. To assess changes in quality of life (QOL), activities of daily living (ADL), patient satisfaction, and social functioning at baseline, discharge, 1 month, 12 months, 36 months, and 60 months post-procedure.
2. To identify clinical and procedural factors associated with improved or worsened outcomes from the perspective of well-being.
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing TAVI or TEER at St Marianna University Hospital who are certified or currently applying for certification as needing long-term care or support under long-term care insurance system in Japan.
Key exclusion criteria
Patients who do not provide informed consent.
Patients under the age of 20.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Taishi |
| Middle name | |
| Last name | Okuno |
Organization
St.Marianna University School of Medicine
Division name
Department of Cardiology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, 216-8511, Kanagawa, Japan
TEL
044-977-8111
taishi.okuno@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Harashima |
Organization
St. Marianna University School of Medicine
Division name
Nursing Department
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, 216-8511, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
yuki.harashima@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St.Marianna University School of Medicine
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
Ethics Committee (Clinical Trials Subcommittee), St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, 216-8511, Kanagawa, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-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
| 2025 | Year | 06 | Month | 09 | 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
| 2025 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 06 | Month | 03 | Day |
Last modified on
| 2025 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066104
