Tokyo, Nov. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059912) titled 'A study on body composition and prognosis in patients undergoing catheter treatment for aortic valve stenosis' on Nov. 28.
Study Type:
Observational
Primary Sponsor:
Institute - Department of Anesthesiology, Osaka Medical and Pharmaceutical University
Condition:
Condition - aortic valve stenosis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to clarify the association between preoperative phase angle (PhA) and 1-year all-cause mortality in patients undergoing TAVI, and to evaluate whether PhA remains an independent prognostic factor after adjustment for established risk factors.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients scheduled to undergo transcatheter aortic valve implantation (TAVI) at our institution
Patients capable of providing written informed consent
Key exclusion criteria - Patients with pacemaker or implantable cardioverter-defibrillator (ICD), in whom bioelectrical impedance analysis (BIA) is contraindicated
Emergency cases
Patients on chronic dialysis
Valve-in-valve cases (redo transcatheter valve implantation within a previously implanted bioprosthetic valve)
Patients undergoing TAVI via non-transfemoral approaches
Patients converted to open surgical aortic valve replacement
Target Size - 150
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 23 Day
Date of IRB - 2025 Year 10 Month 23 Day
Anticipated trial start date - 2025 Year 11 Month 12 Day
Last follow-up date - 2029 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067761
Disclaimer: Curated by HT Syndication.
