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

NCT07108478 · tracked via the Priya Life Science China tracker

Sponsor

Qilu Hospital of Shandong University

Phase

Observational

Started

2025-07-30

Last updated

2025-08-07

Condition(s) studied

Severe Aortic Valve Stenosis

Investigational drug(s) / intervention(s)

Transcatheter aortic valve and recyclable delivery system

Transcatheter aortic valve and recyclable delivery system: In this study, the transcatheter aortic valve and its recycling delivery system were VitaFlow Liberty®, a TAVR product independently developed by Shanghai Minimally Invasive Cardiovascular Treatment Co., Ltd. (approved and marketed by NMPA). This product is equipment/consumables routinely purchased by hospitals. For routine clinical use, it is designed for transcatheter aortic valve implantation. The valve is delivered to the intended implantation site via the peripheral artery by retrograde flow through the delivery system, realizing the delivery, positioning and release of the valve. Under the supervision of medical imaging equipment, the valve is delivered to the lesion site of the aortic valve, and marked by the diseased aortic annulus, to release the valve and relieve the stenosis at the lesion site, thereby ensuring smooth aortic flow, improving cardiac function and achieving therapeutic purposes.

Study 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.

Eligibility

Sex

ALL

Min age

70 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. 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); 2. Meet one of the following emergent TAVR indications: 1\) 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 Criteria: 1. Aortic root anatomy and lesions are not suitable for prosthetic valve implantation; 2. Anatomic morphology or vascular diseases affecting the instrument approach; 3. Left ventricular outflow tract obstruction; 4. Primary dilated cardiomyopathy; 5. Thrombus in the left ventricle; 6. Patients who are unable to receive anticoagulation or antiplatelet therapy; 7. Allergy to or resistance to Nitinol; 8. Active stage of infective endocarditis or other infection that the researcher believes affects the operation; 9. Severe disability senile dementia; 10. Patients with a life expectancy of less than half a year; 11. The investigator determined that the patient or family had poor compliance or declined to complete the study as required.

Primary outcome measure(s)

Cumulative all-cause mortality at 12 months postoperatively — 12 months
All-cause death includes cardiac death and non-cardiac death

Trial sites (1)

Facility	City	Region	Status
Qilu Hospital of Shandong University	Jinan	Shandong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07108478 on ClinicalTrials.gov ↗ ← All trials in China