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

Trial details

Who runs it

Qilu Hospital of Shandong University

Trial code

NCT07108478

Record updated

7 August 2025

Original description

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.Read full original descriptionShow less

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.

Inclusion: Patients with severe aortic stenosis diagnosed at the clinic: peak transvalvular flow velocity ≥4.0m/s, or mean transvalvular pressure difference ≥40mmHg(1 mmHg=0.133kPa), or aortic valve orifice area < <0.8cm2 (or effective aortic valve orifice area index < 0.5 cm2/m2); Meet one of the following emergent TAVR indications:; Shock; 2) Combined with persistent ventricular tachycardia or ventricular fibrillation; 3) Difficulty in improving unstable angina pectoris or chronic heart failure requiring mechanical circulatory assistance with drugs; 4) Cardiopulmonary resuscitation is required for cardiac arrest; 3. Patients who can understand the purpose of the study, voluntarily participate in and sign the informed consent form, and are willing to accept the relevant examinations and clinical follow-up.

Exclusion: Patients who are unable to receive anticoagulation or antiplatelet therapy; Anatomic morphology or vascular diseases affecting the instrument approach; Allergy to or resistance to Nitinol; Active stage of infective endocarditis or other infection that the researcher believes affects the operation; Severe disability senile dementia; Aortic root anatomy and lesions are not suitable for prosthetic valve implantation; Left ventricular outflow tract obstruction; Primary dilated cardiomyopathy; Thrombus in the left ventricle; Patients with a life expectancy of less than half a year; The investigator determined that the patient or family had poor compliance or declined to complete the study as required.

ClinicalTrials.gov NCT07108478