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

NCT07108478 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2025-08-07

No results posted yet for this 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.

Conditions

  • Severe Aortic Valve Stenosis

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2028-02-28
Completion
2028-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07108478 on ClinicalTrials.gov