Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis

NAActive, not recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

September 22, 2017

Primary Completion Date

May 11, 2020

Study Completion Date

May 30, 2024

Conditions
Aortic Stenosis
Interventions
DEVICE

TaurusOne® transcatheter aortic valve replacement system

The TaurusOne® Transcatheter Aortic Valve System consists of an aortic valve, an associated delivery catheter and a loading system. The aortic valve consists of a self-expanding nitinol frame, a sealing skirt and valve leaflets, which are made of bovine pericardium. The delivery system is mainly composed of conical head, opacity ring, inner tube, top ring, middle tube, outer tube, booster rod, stress diffusion catheter, handle, etc. The outflow end of the aortic valve is provided with three fixing holes evenly distributed on the circumference on the top ring of the delivery catheter, so as to facilitate the installation, delivery and release of the aortic valve. Before the operation, the aortic valve needs to be installed into the sheath of the delivery catheter as required.

Trial Locations (1)

215025

Peiga Medical Technology (Suzhou) Co., Ltd, Suzhou

All Listed Sponsors
collaborator

Fu Wai Hospital, Beijing, China

OTHER

collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

collaborator

West China Hospital

OTHER

collaborator

General Hospital of Shenyang Military Region

OTHER

collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

collaborator

Second Xiangya Hospital of Central South University

OTHER

lead

Peijia Medical Technology (Suzhou) Co., Ltd.

INDUSTRY

NCT04815785 - Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis | Biotech Hunter | Biotech Hunter