UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060569 |
|---|---|
| Receipt number | R000069070 |
| Scientific Title | Concordance of Epicardial and Transesophageal Echocardiography for Assessment of Aortic Valve Neocuspidization: A Prospective Paired Agreement Study |
| Date of disclosure of the study information | 2026/02/05 |
| Last modified on | 2026/02/03 17:26:42 |
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Basic information
Public title
Concordance of Epicardial and Transesophageal Echocardiography for Assessment of Aortic Valve Neocuspidization
Acronym
Concordance of Epicardial and Transesophageal Echocardiography for Assessment of Aortic Valve Neocuspidization
Scientific Title
Concordance of Epicardial and Transesophageal Echocardiography for Assessment of Aortic Valve Neocuspidization: A Prospective Paired Agreement Study
Scientific Title:Acronym
Concordance of Epicardial and Transesophageal Echocardiography for Assessment of Aortic Valve Neocuspidization: A Prospective Paired Agreement Study
Region
| Africa |
Condition
Condition
active
Classification by specialty
| Cardiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary Objective: To assess the agreement (reliability) between EpiE and TEE measurements of coaptation length following Ozaki aortic valve neocuspidization.
Secondary Objectives: Compare agreement in aortic valve area (AVA), mean pressure gradient, and residual aortic regurgitation (AR) grade.
Evaluate intra- and inter-observer reproducibility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EpiE and TEE measurements of coaptation length
Key secondary outcomes
measurement of aortic valve area (AVA), mean pressure gradient, and residual aortic regurgitation (AR) grade
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
"Forty adult patients 18 years or older undergoing elective Ozaki aortic valve neocuspidization"
Key exclusion criteria
"emergency operations, contraindications to TEE and cases in which paired EpiE-TEE imaging cannot be obtained"
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mohammed |
| Middle name | Adel |
| Last name | Hegazy |
Organization
Mansoura University
Division name
cardiothoracic and vascular surgery center
Zip code
35516
Address
Manoura university, Egypt
TEL
+20502269988
cvsc@mans.edu.eg
Public contact
Name of contact person
| 1st name | Mohammed |
| Middle name | Adel |
| Last name | Hegazy |
Organization
mansoura university
Division name
cardiothoracic and vascular surgery center
Zip code
35516
Address
Manoura, Egypt
TEL
+201002025982
Homepage URL
dr_mhegazy7000@mans.edu.eg
Sponsor or person
Institute
cardiothoracic and vascular surgery center
Institute
Department
Personal name
Funding Source
Organization
cardiothoracic and vascular surgery center
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
Institutional Research Board, Manoura faculty of medicine
Address
Manoura, Egypt
Tel
+20502202773
irb_staff@mans.edu.eg
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
cardiothoracic and vascular surgery center
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 05 | 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
| 2026 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After weaning from cardiopulmonary bypass and hemodynamic stabilization MAP 65 to 85 mmHg both TEE and EpiE will be performed sequentially Standardized acquisition views will be used
Management information
Registered date
| 2026 | Year | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069070
