Tokyo, June 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061849) titled 'Left ventricular function before transcatheter aortic valve implantation in patients with severe aortic stenosis.' on June 9.
Study Type:
Observational
Primary Sponsor:
Institute - Mie University
Condition:
Condition - severe Aortic valve stenosis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We will evaluate the effects of cardiovascular function indices at the time of TAVI on the rate of change in left ventricular mass index and on the occurrence of cardiovascular events after TAVI.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients undergoing TAVI for severe aortic stenosis.
Key exclusion criteria - 1)Patients undergoing hemodialysis with severe renal dysfunction.
2)Patients with left ventricular ejection fraction less than 40%
3)Patients with aortic valve peal velocity of 5 m/s or more.
4)Patients with unstable condition due to insufficient control of heart failure.
5)Patients with atrial fibrillation.
6)Patients who are judged inappropriate for inclusion in the study by the principal investigator/co-investigator.
Target Size - 68
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2023 Year 08 Month 06 Day
Date of IRB - 2023 Year 10 Month 26 Day
Anticipated trial start date - 2023 Year 10 Month 26 Day
Last follow-up date - 2031 Year 08 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058487
Disclaimer: Curated by HT Syndication.
