Clinical Trial

A Prospective, Multicenter, Observational Study of the Safety and Efficacy of Emergency Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis

Study acronym: E-TAVR-2025
Not Yet Recruiting
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Summary
The research name of this project is: A prospective, multicenter and observational study on the safety and effectiveness of emergency transcatheter aortic valve replacement (TAVR) in the treatment of patients with severe aortic stenosis. It is a prospective, multi-center clinical study, and 35 cases are planned to be enrolled and followed up for 12 months (before discharge, 30 days, 6 months and 12 months). The research instruments used are VitaFlow Liberty® transcatheter aortic valve and recoverable delivery system. The purpose of this study is to evaluate the safety and effectiveness of emergency TAVR in patients with severe aortic stenosis. The main end point is the cumulative all-cause mortality 12 months after operation, and the secondary end points mainly include adverse cerebrovascular events (MACCE), acute renal injury, implantation rate of permanent pacemaker and valve function.
Trial Details
NCT Number NCT07108478
Lead Sponsor Qilu Hospital of Shandong University
Conditions Severe Aortic Valve Stenosis
Enrollment 35 participants
Start Date 2025-07-30
Primary Completion 2028-02-28 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-07