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INSPIRIS China PMCF Study

NCT05404880 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 255

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

  • Aortic Valve Replacement

Interventions

DEVICE

EDWARDS INSPIRIS RESILIA Aortic Valve

Surgical replacement of the aortic valve with the INSPIRIS RESILIA Aortic Valve.

Sponsors & Collaborators

  • Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.

    collaborator INDUSTRY

  • Rundo International Pharmaceutical Research & Development Co.,Ltd.

    collaborator INDUSTRY

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Hansong Sun, Professor · Chinese Academy of Medical Sciences, Fuwai Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-13
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05404880 on ClinicalTrials.gov