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

Not yet recruitingOBSERVATIONAL
Enrollment

35

Participants

Timeline

Start Date

July 30, 2025

Primary Completion Date

February 28, 2028

Study Completion Date

December 30, 2028

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.

Trial Locations (1)

250000

Qilu Hospital of Shandong University, Jinan

All Listed Sponsors
lead

Qilu Hospital of Shandong University

OTHER