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Active Not Recruiting NCT05404880

INSPIRIS China PMCF Study

Conditions: Aortic Valve Replacement

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 255
Sponsor: Edwards Lifesciences

Location: Beijing Anzhen Hospital, Capital Medical University Beijing Beijing Municipality

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.

Eligibility Criteria

Inclusion Criteria: 1. Subject is 18 years or older 2. Subjects requiring an elective replacement of their native or prosthetic aortic valve as indicated per the IFU 3. Subject is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, with or without ascending aorta replacement 4. Provide signed informed consent prior to the study participation Exclusion Criteria: 1. Valve implantation is contraindicated per the IFU 2. Requires planned multiple valve replacement/ repair 3. Has active endocarditis/myocarditis prior to the scheduled aortic replacement surgery 4. Estimated Life expectancy\< 12 months 5. Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05404880). StuddyBuddy aggregates publicly available trial information.