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Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI

NCT02221921 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2014-08-21

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for Surgical Valve Replacement.

Conditions

  • Aortic Valve Disease
  • Aortic Valve Stenosis
  • Aortic Valve Calcification

Interventions

DEVICE

MicroPort's Transcatheter Aortic Valve and Delivery System

Sponsors & Collaborators

  • Shanghai MicroPort Medical (Group) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • JunBo Ge, Medical Doctor, Professor · Shanghai Zhongshan 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
2014-09-30
Primary Completion
2016-09-30
Completion
2021-09-30

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 NCT02221921 on ClinicalTrials.gov