This study looks at how safe and effective the Medtronic Avalus Ultra aortic valve is for people with aortic valve disease. Aortic valve disease means the heart valve can't open or close properly. The study will include about 150 people in the United States who will have this new valve put in and be watched for one year.
To be in the study, you need to have a heart problem called aortic stenosis or regurgitation, which means your heart valve is too narrow or leaky. You also must be able to come back for check-ups and be old enough to give permission to join the study.
Some people cannot join this study. If you have certain other heart problems, have had this valve taken out before, or have other serious health issues, you can't be in it.
- Length of Study: Follow-up visits required for one year after the procedure.
- Eligibility: Must have specific heart issues and be able to attend follow-up visits.
- Risks: Must understand risks and be willing to give informed consent.
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