Status:
ACTIVE_NOT_RECRUITING
INSPIRIS China PMCF Study
Lead Sponsor:
Edwards Lifesciences
Collaborating Sponsors:
Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Conditions:
Aortic Valve Replacement
Eligibility:
All Genders
18+ years
Brief 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 implantat...
Eligibility Criteria
Inclusion
- Subject is 18 years or older
- Subjects requiring an elective replacement of their native or prosthetic aortic valve as indicated per the IFU
- Subject is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, with or without ascending aorta replacement
- Provide signed informed consent prior to the study participation
Exclusion
- Valve implantation is contraindicated per the IFU
- Requires planned multiple valve replacement/ repair
- Has active endocarditis/myocarditis prior to the scheduled aortic replacement surgery
- Estimated Life expectancy\< 12 months
- Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
Key Trial Info
Start Date :
July 13 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2029
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT05404880
Start Date
July 13 2022
End Date
December 1 2029
Last Update
March 21 2025
Active Locations (13)
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1
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, China, 230002
2
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029
3
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, China, 100037
4
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China, 361008