NCT05404880

INSPIRIS China PMCF Study

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 255 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Aortic Valve Replacement

Interventions

Type	Name	Description
DEVICE	EDWARDS INSPIRIS RESILIA Aortic Valve	Surgical replacement of the aortic valve with the INSPIRIS RESILIA Aortic Valve.

Timeline

• Start date: 2022-07-13
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2022-06-03
• Last updated: 2026-03-25

Locations

13 sites across 1 country: China

Regulatory

• FDA-regulated device study