MedTrace Logo

Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis

NCT01683474 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-01-06

No results posted yet for this study

Summary

1. objectives

* Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery
* Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
* Continuous observe 12 months of safety and efficacy.
2. Approximately 80 patients presenting with native aortic valve stenosis necessitating valve replacement which are considered unsuitable for Surgical Valve Replacement, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study.
3. Safety and performance will be evaluated at discharge and at 30 days post procedure. Valve safety, performance and placement will be followed up at 6 and 12 months post-procedure.

Conditions

  • Aortic Valve Stenosis
  • Aortic Valve Calcification

Interventions

DEVICE

Venus MedTech Aortic Valve Prosthesis

Percutaneous implantation of aortic valve of Venus-A

Sponsors & Collaborators

  • Venus MedTech (HangZhou) Inc.

    lead INDUSTRY

Principal Investigators

  • Ruilin Gao, MD · Chinese Academy of Medical Sciences, Fuwai 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
2012-09-30
Primary Completion
2016-02-29
Completion
2016-04-30

Countries

  • China

Study Locations

More Related Trials

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 NCT01683474 on ClinicalTrials.gov