NCT03575039

VitaFlowTM II Transcatheter Aortic Valve System Study

The VITALE Study Evaluating Safety and Effectiveness/Performance of the Microport CardioFlow VitaFlow II - Transcatheter Aortic Valve System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	VitaFlow II Transcatheter Aortic Valve System	VitaFlow II Transcatheter Aortic Valve System contains a Valve stent -VitaFlow Aortic Valve, a Delivery system-VitaFlow II Delivery System and a Introducer set

Timeline

• Start date: 2018-08-01
• Primary completion: 2020-12-01
• Completion: 2024-12-01
• First posted: 2018-07-02
• Last updated: 2018-07-02