VitaFlowTM II Transcatheter Aortic Valve System Study

Status Not yet recruiting

Clinical Trial Summary

A prospective, single arm clinical investigation evaluating safety and effectiveness/performance of the Microport CardioFlow VitaFlowTM II - Transcatheter Aortic Valve System for the treatment of symptomatic severe aortic stenosis via transcatheter access in increased surgical risk patients

Clinical Trial Description

This is a prospective, multicenter, single arm and controlled clinical investigation compared to recent historical results. The purpose is to evaluate the safety, performance and efficacy of the VitaflowTM II Transcatheter Aortic Valve system.

The entire system including valve system, delivery system and introducer system. We will implant the valve system into subjects and followed up them for 5 years after the procedure. This clinical trial will be conducted in 15 sites in Europe. ;

Study Design

Related Conditions & MeSH terms

Aortic Valve Stenosis

Clinical Trial Details

NCT number	NCT03575039
Study type	Interventional
Source	Shanghai MicroPort CardioFlow Medtech Co.,Ltd.
Contact	Ada Wang
Phone	86-021-38954600-7814
Email	wanglu2@microport.comwajin
Status	Not yet recruiting
Phase	N/A
Start date	August 2018
Completion date	December 2024

View Details

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