Tokyo, Feb. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060569) titled 'Concordance of Epicardial and Transesophageal Echocardiography for Assessment of Aortic Valve Neocuspidization' on Feb. 5.
Study Type:
Observational
Primary Sponsor:
Institute - cardiothoracic and vascular surgery center
Condition:
Condition - active
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 18
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 Size - 40
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069070
Disclaimer: Curated by HT Syndication.
