Active, not recruiting
INSPIRIS China PMCF Study
Post-Market Clinical Follow-up Study of Edwards Lifesciences INSPIRIS RESILIA Aortic Valve in Chinese Population
- Sponsor
- Edwards Lifesciences (Industry)
- Enrolment
- 255 enrolled
- Conditions
- Aortic Valve Replacement
- Interventions
- EDWARDS INSPIRIS RESILIA Aortic Valve
- Ages
- adults, older adults
- Registry
- NCT05404880
From the registry
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.
Primary outcomes
- Subject's Occurrence Rate of Study Valve Related Death
- Subject's Occurrence Rate of Structural Valve Deterioration
- Subject's Occurrence Rate of Re-operation on the Study Valve
- Subject's Occurrence Rate of Major Bleeding