The purpose of this trial is to determine the safety and effectiveness of an aortic valve device in patients with critical narrowing of the aortic valve that are deemed high risk and are not surgical candidates. The main goals are to successfully place the aortic valve device, relieving or possibly eliminating the narrowing in the valve, while avoiding complications.
You may be eligible to participate in this study if you:
- Have aortic valve stenosis
- Are symptomatic from his/her aortic valve stenosis,
- Have medical factors that may make them unable to have surgery to repair aortic valve
- Agree to comply with all required post-procedure follow-up visits including annual visits through five years and analysis close date visits
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.