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VitaFlowTM II Transcatheter Aortic Valve System Study

NCT03575039 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2018-07-02

No results posted yet for this study

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

Conditions

  • Aortic Valve Stenosis

Interventions

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

Sponsors & Collaborators

  • Shanghai MicroPort CardioFlow Medtech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Nicolo Piazza · Bern Unversity Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2020-12-31
Completion
2024-12-31

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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 NCT03575039 on ClinicalTrials.gov