INSPIRIS China PMCF Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-13

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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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

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Aortic Valve Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EDWARDS INSPIRIS RESILIA Aortic Valve

Subjects who were treated with the INSPIRIS RESILIA aortic heart valve.

EDWARDS INSPIRIS RESILIA Aortic Valve

Intervention Type DEVICE

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

Interventions

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EDWARDS INSPIRIS RESILIA Aortic Valve

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No