NCT01683474

Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Venus MedTech (HangZhou) Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Aortic Valve Stenosis
• Aortic Valve Calcification

Interventions

Type	Name	Description
DEVICE	Venus MedTech Aortic Valve Prosthesis	Percutaneous implantation of aortic valve of Venus-A

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-02-01
• Completion: 2016-04-01
• First posted: 2012-09-11
• Last updated: 2015-01-06

Locations

1 site across 1 country: China