UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054628 |
|---|---|
| Receipt number | R000061380 |
| Scientific Title | Comparison of Invasively-measured and Echocardiography-derived Prosthesis-patient Mismatch Following Transcatheter Aortic Valve Replacement |
| Date of disclosure of the study information | 2024/06/17 |
| Last modified on | 2024/06/11 16:06:27 |
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Basic information
Public title
Comparison of Invasively-measured and Echocardiography-derived Prosthesis-patient Mismatch Following Transcatheter Aortic Valve Replacement
Acronym
Invasive PPM Registry
Scientific Title
Comparison of Invasively-measured and Echocardiography-derived Prosthesis-patient Mismatch Following Transcatheter Aortic Valve Replacement
Scientific Title:Acronym
Invasive PPM Registry
Region
| Japan |
Condition
Condition
Aortic Stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence, severity, and prognostic impact of prosthesis-patient mismatch based on invasively-measured and echocardiography-derived effective orifice area.
Basic objectives2
Others
Basic objectives -Others
To evaluate the discordance in hemodynamic performance measurements of the implanted transcatheter heart valve between invasive methods and echocardiography according to the valve type and size.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Prosthesis-patient mismatch
Key secondary outcomes
Hemodynamic indices, including effective orifice area, transvalvular mean pressure gradient, paravalvular regurgitation. Death (all-cause, cardiovascular, and non-cardiovascular). Readmission event (heart failure, pneumonia, bleeding event, etc.). Heart valve deterioration and thrombosis formation evaluated by transthoracic echocardiography and/or computed tomography.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Right heart catheterization
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients deemed suitable for TAVI by a local heart team and undergoing the procedure
Key exclusion criteria
Patients who did not meet the criteria of technical success as defined by the Valve Academic Research Consortium 3
Target sample size
100
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 | 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
Homepage URL
taishi.okuno@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Taishi Okuno
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, 216-8511, Kanagawa, Japan
Tel
044-977-8111
taishi.okuno@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
| 2024 | Year | 06 | Month | 17 | 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 | 06 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 17 | 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
Management information
Registered date
| 2024 | Year | 06 | Month | 11 | Day |
Last modified on
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061380
