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Safety, Clinical Efficacy and Time-to-event Survival in Patients With Degenerative Aortic Valve Disease Scheduled for Stented Biological Aortic Valve Replacement Versus Allograft Aortic Root Replacement.
The aim of the observational study is to compare safety, clinical efficacy and time-to-event survival in patients age of 60-74 years with degenerative aortic valve disease that underwent aortic valve replacement with either stented biological prosthesis or aortic allograft.
Early safety included morbidity, mortality rate, freedom from any valve related complications Clinical efficacy included mid-term survival, freedom from reoperation, repeat endocarditis and other valve related complication Time-to-event analysis included freedom from all-cause and cardio-vascular mortality, freedom from stroke, major bleeding, endocarditis, structural valve deterioration and reoperation
Age
60 - 74 years
Sex
ALL
Healthy Volunteers
No
Start Date
January 12, 2017
Primary Completion Date
June 30, 2024
Completion Date
September 29, 2025
Last Updated
October 7, 2025
93
ACTUAL participants
aortic valve/root replacement
PROCEDURE
Lead Sponsor
Chelyabinsk Regional Clinical Hospital
NCT07333495
NCT06018766
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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