clinical trial · NCT05404880
INSPIRIS China PMCF Study
Edwards Lifesciences·—·active not recruiting·n = 255
Aortic Valve ReplacementEDWARDS INSPIRIS RESILIA Aortic Valve
brief 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.
started
Jul 13, 2022
primary completion
Dec 1, 2028
completion
Dec 1, 2029
last updated
Mar 25, 2026
detailed 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.
official title
Post-Market Clinical Follow-up Study of Edwards Lifesciences INSPIRIS RESILIA Aortic Valve in Chinese Population
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol