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INSPIRIS China PMCF Study — INSPIRIS China  

Aortic Valve Replacement Clinical Trial

Official title:
Post-Market Clinical Follow-up Study of Edwards Lifesciences INSPIRIS RESILIA Aortic Valve in Chinese Population

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05404880
Study type Observational [Patient Registry]
Source Edwards Lifesciences
Contact
Status Active, not recruiting
Phase
Start date July 13, 2022
Completion date December 2029
View Details
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