UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061849 |
|---|---|
| Receipt number | R000058487 |
| Scientific Title | Left ventricular function before transcatheter aortic valve implantation in patients with severe aortic stenosis. |
| Date of disclosure of the study information | 2026/06/09 |
| Last modified on | 2026/06/09 16:21:16 |
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Basic information
Public title
Left ventricular function before transcatheter aortic valve implantation in patients with severe aortic stenosis.
Acronym
TAVI PV loop
Scientific Title
Left ventricular function before transcatheter aortic valve implantation in patients with severe aortic stenosis.
Scientific Title:Acronym
TAVI PV loop
Region
| Japan |
Condition
Condition
severe Aortic valve stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the effects of cardiovascular function indices at the time of TAVI on the rate of change in left ventricular mass index and on the occurrence of cardiovascular events after TAVI.
Basic objectives2
Others
Basic objectives -Others
cardiovascular function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome is to evaluate the effect of left ventricular stiffness in patients undergoing TAVI on the rate of change in left ventricular mass index 6 months after TAVI.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing TAVI for severe aortic stenosis.
Key exclusion criteria
1)Patients undergoing hemodialysis with severe renal dysfunction.
2)Patients with left ventricular ejection fraction less than 40%
3)Patients with aortic valve peal velocity of 5 m/s or more.
4)Patients with unstable condition due to insufficient control of heart failure.
5)Patients with atrial fibrillation.
6)Patients who are judged inappropriate for inclusion in the study by the principal investigator/co-investigator.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Dohi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie
TEL
059-232-1111
naika1@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Kirii |
Organization
Mie University Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie
TEL
059-232-1111
Homepage URL
naika1@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University
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
Mie University Graduate School of Medicine
Address
2-174, Edobashi, Tsu, Mie
Tel
059-232-1111
naika1@med.mie-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
| 2026 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2031 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Assessments and Data Collection at Enrollment
NYHA functional class
Mini-Mental State Examination (MMSE)
General physical findings, Blood tests, Biochemical tests
Electrocardiography, ABI/baPWV
Echocardiography
Cardiac MRI: left ventricular end-diastolic volume, left ventricular end-diastolic volume index, left ventricular end-systolic volume, left ventricular end-systolic volume index, left ventricular ejection fraction, stroke volume, cardiac output, left ventricular myocardial mass, left ventricular global longitudinal strain, and native T1 value
Contrast-enhanced CT
Six-minute walk distance
During Transcatheter Aortic Valve Implantation
Measurement of the left ventricular pressure-volume relationship:
During transcatheter aortic valve implantation, after measuring left ventricular pressure using a pigtail catheter routinely inserted into the left ventricle, the catheter will be exchanged for a conductance catheter inserted into the left ventricle over a guidewire. The pressure-volume relationship will be recorded under steady-state conditions and during transient inferior vena cava occlusion.
Assessments After Transcatheter Aortic Valve Implantation
NYHA functional class
Mini-Mental State Examination (MMSE)
General physical findings, Blood tests, Biochemical tests
Electrocardiography, ABI/baPWV
Echocardiography
Cardiac MRI: left ventricular end-diastolic volume, left ventricular end-diastolic volume index, left ventricular end-systolic volume, left ventricular end-systolic volume index, left ventricular ejection fraction, stroke volume, cardiac output, left ventricular myocardial mass, left ventricular global longitudinal strain, and native T1 value
Contrast-enhanced CT
Six-minute walk distance
Adverse events
Management information
Registered date
| 2026 | Year | 06 | Month | 09 | Day |
Last modified on
| 2026 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058487
