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