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VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial

NCT04414878 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2020-06-04

No results posted yet for this study

Summary

This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.

Conditions

  • Aortic 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™ Delivery System, loading tools, and a guide-wire

Sponsors & Collaborators

  • Shanghai MicroPort CardioFlow Medtech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2022-01-31
Completion
2027-01-31

Countries

  • China

Study Locations

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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 NCT04414878 on ClinicalTrials.gov