UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057959 |
|---|---|
| Receipt number | R000066265 |
| Scientific Title | Prognostic Utility of Left Ventricular Ejection Fraction in Patients Undergoing Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-Analysis |
| Date of disclosure of the study information | 2025/05/25 |
| Last modified on | 2025/11/25 10:54:47 |
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Basic information
Public title
Prognostic Utility of Left Ventricular Ejection Fraction in Patients Undergoing Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-Analysis
Acronym
Prognostic Role of LVEF in TAVI Patients
Scientific Title
Prognostic Utility of Left Ventricular Ejection Fraction in Patients Undergoing Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-Analysis
Scientific Title:Acronym
Prognostic Role of LVEF in TAVI Patients
Region
| Japan |
Condition
Condition
aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Left ventricular ejection fraction (LVEF) is widely used to assess systolic function and predict cardiovascular outcomes, but its prognostic role in patients undergoing transcatheter aortic valve implantation (TAVI) remains uncertain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pooled hazard ratio of LVEF in TAVI patients
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Studies were included if they met the following criteria: (1) adult patients with AS undergoing TAVI; (2) baseline LVEF assessed using transthoracic echocardiography; (3) clinical outcomes such as all-cause death (ACD), cardiovascular death (CD), or MACE reported; (4) availability of HRs and 95% CIs from univariable or multivariable Cox regression analysis; and (5) sufficient data to calculate effect sizes. If multiple publications involved overlapping cohorts, we included the study with the most detailed or recent data.
Key exclusion criteria
Studies that did not analyze LVEF as a continuous variable were excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Nabeshima |
Organization
Saga University
Division name
Department of Cardiovascular Medicine
Zip code
849-0937
Address
Nabeshima 5-1-1, Saga City
TEL
0952-31-6511
y.nabeshima1016@gmail.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Nabeshima |
Organization
Saga University
Division name
Department of Cardiovascular Medicine
Zip code
849-8501
Address
Nabeshima 5-1-1, Saga City
TEL
0952316511
Homepage URL
y.nabeshima1016@gmail.com
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
CLINICAL RESEARCH CENTER,SAGA UNIVERSITY HOSPITAL
Address
Nabeshima 5-1-1, Saga City
Tel
0952343400
kenkyu-shinsei@ml.cc.saga-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 | 05 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/circrep/7/10/7_CR-25-0126/_article/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circrep/7/10/7_CR-25-0126/_article/-char/ja
Number of participants that the trial has enrolled
75085
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
Completed
Date of protocol fixation
| 2025 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We extracted information on study characteristics such as the first author, publication year, country, reported ethnicity, and study design. Patient demographic data included sample size, mean age, and proportion of female participants. Echocardiographic parameters such as LVEF,AVA, mPG, and SVi were also collected. HRs, 95% CIs, and types of endpoints were also extracted. When studies reported both univariable and multivariable HRs, we included both in the analysis. All extracted data were compiled into a CSV file.
Management information
Registered date
| 2025 | Year | 05 | Month | 25 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066265
