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Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis — Venus-A  

Aortic Valve Stenosis Clinical Trial

Official title:
Clinical Evaluation of the Safety and Performance of Percutaneous Implantation of the Venus MedTech Aortic Valve Prosthesis for Patients Who Cannot Undergo Surgical Valve Replacement

Clinical Trial 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.

Clinical Trial Description

A prospective OPC study to evaluate its performance and long-term safety and effectiveness of Venus-A aortic valve. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01683474
Study type Interventional
Source Venus MedTech (HangZhou) Inc.
Contact Runlin Gao, MD
Phone 88398866
Email gaorunlin4study@gmail.com
Status Recruiting
Phase N/A
Start date September 2012
Completion date April 2016
View Details
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