Avalus Ultra Post-Approval Study (PAS)
The purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease.
∙ Subjects must meet the following criteria to be included in the study:
• Subject has moderate or greater aortic stenosis or regurgitation, and there is a clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:
‣ Atrial fibrillation (AF) ablation
⁃ Ascending aortic aneurysm or dissection repair or replacement, with or without circulatory arrest
⁃ Coronary artery bypass graft (CABG)
⁃ Surgical management of the left atrial appendage (LAA)
⁃ Patent foramen ovale (PFO) closure
⁃ Resection of a sub-aortic membrane not requiring myectomy
• Subject is geographically stable and willing to return to the implanting site for all follow-up visits
• Subject is of legal age to provide informed consent
• Subject has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation in the study