UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058864 |
|---|---|
| Receipt number | R000067315 |
| Scientific Title | Risk Factors and Clinical Outcomes of Hypo-attenuated Leaflet Thickening (HALT) After Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-analysis |
| Date of disclosure of the study information | 2025/08/22 |
| Last modified on | 2025/08/22 10:35:30 |
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Basic information
Public title
Risk Factors and Clinical Outcomes of Hypo-attenuated Leaflet Thickening (HALT) After Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-analysis
Acronym
Risk Factors and Clinical Outcomes of Hypo-attenuated Leaflet Thickening (HALT) After Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-analysis
Scientific Title
Risk Factors and Clinical Outcomes of Hypo-attenuated Leaflet Thickening (HALT) After Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-analysis
Scientific Title:Acronym
HALT After TAVR: Risk Factors and Outcomes Meta-analysis
Region
| Japan |
Condition
Condition
patients who underwent transcatheter aortic valve replacement (TAVR)
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate risk factors for the occurrence of hypo-attenuated leaflet thickening (HALT) after transcatheter aortic valve replacement (TAVR) and to evaluate the impact of HALT on clinical outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prosthetic valve transvalvular pressure gradient in patients with HALT, number of early and late deaths in patients with HALT, number of stroke and transient ischemic attack (TIA) events in patients with HALT
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Studies including patients with aortic stenosis who underwent transcatheter aortic valve replacement (TAVR).
2.Studies evaluating the incidence (number of events) of hypo-attenuated leaflet thickening (HALT) and clinical outcomes.
3.Eligible study designs: retrospective and prospective observational studies, and randomized controlled trials (RCTs).
Key exclusion criteria
We excluded case reports, case series, animal studies
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
+81-45-787-2800
yasuda.nao.mz@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Naofumi |
| Middle name | |
| Last name | Yasuda |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
+81-45-787-2800
Homepage URL
yasuda.nao.mz@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Diagnostic Radiology, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Yokohama city university
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
Tel
+81-45-787-2800
yasuda.nao.mz@yokohama-cu.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 | 08 | Month | 22 | 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 | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We used the methods suggested by the Cochrane Collaboration and met the reporting standards of the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guideline of 2020. We conducted a database search using PubMed, Web of Science Core Collection, and EMBASE electronic database. After screening all titles and abstracts in the search results, potentially relevant studies were reviewed in full by two reviewer. Institutional review board approval was not obtained for this study because it is a meta-analysis, and therefore, does not deal with clinical patient information.
Management information
Registered date
| 2025 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067315
