Aortic Valve Replacement Clinical Trial
Official title:
Post-Market Clinical Follow-up Study of Edwards Lifesciences INSPIRIS RESILIA Aortic Valve in Chinese Population
The objective of this post-market trial is to evaluate long term safety and performance of the Edwards Lifesciences INSPIRIS RESILIA aortic valve in Chinese patients in a real-world clinical setting.
The trial is a multi-center, prospective, single-arm study that will enroll up to 250 subjects. The study is being divided into 2 stages: Stage 1 is enrollment and 5 years of follow-up after implantation. Stage 2 is additional follow-up through 10 years upon authority's feedback if needed. ;
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