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
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.
A prospective OPC study to evaluate its performance and long-term safety and effectiveness of Venus-A aortic valve. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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