UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058575 |
|---|---|
| Receipt number | R000066978 |
| Scientific Title | Registry Study on Percutaneous Ventricular Assist Devices at Shiga University of Medical Science |
| Date of disclosure of the study information | 2025/07/24 |
| Last modified on | 2025/07/24 10:28:13 |
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Basic information
Public title
Registry Study on Percutaneous Ventricular Assist Devices at Shiga University of Medical Science
Acronym
Registry Study on Percutaneous Ventricular Assist Devices at Shiga University of Medical Science
Scientific Title
Registry Study on Percutaneous Ventricular Assist Devices at Shiga University of Medical Science
Scientific Title:Acronym
Registry Study on Percutaneous Ventricular Assist Devices at Shiga University of Medical Science
Region
| Japan |
Condition
Condition
Hospitalized Patients Undergoing Support with Percutaneous Mechanical Circulatory Support Catheters
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study involves the collection of information on patient backgrounds, diagnoses, treatment details, and clinical courses during both the acute and chronic phases, using data extracted from medical records (including electronic health records and laboratory test results), in hospitalized patients who have undergone treatment with percutaneous mechanical circulatory support catheters.
Basic objectives2
Others
Basic objectives -Others
The information obtained from this study will be used to understand the current clinical use of percutaneous mechanical circulatory support catheters, to support the development of a high-quality healthcare delivery system, to clarify the clinical risks, benefits, and patient outcomes associated with their use, and to promote the safe and appropriate utilization of these devices in Shiga Prefecture and throughout Japan.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Post-discharge survival
Key secondary outcomes
Discharge outcomes, occurrence and duration of rehospitalization-requiring events, and changes in post-discharge living conditions
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 aged 20 years or older who were hospitalized and received treatment with a percutaneous mechanical circulatory support catheter, regardless of the underlying diagnosis.
Key exclusion criteria
Patients deemed inappropriate for inclusion in the study due to insufficient medical record data or other relevant reasons.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Takabayashi |
Organization
Shiga University of Medical Science
Division name
Department of Cardiovascular Medicine
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, Japan
TEL
077-548-2213
ktkb@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Takabayashi |
Organization
Shiga University of Medical Science
Division name
Department of Cardiovascular Medicine
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, Japan
TEL
077-548-2213
Homepage URL
ktkb@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Shiga University of Medical Science
Address
Seta Tsukinowa-cho, Otsu, Shiga, Japan
Tel
077-548-3618
hqrec@belle.shiga-med.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 | 07 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2030 | Year | 05 | 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
| 2025 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066978
