INSPIRIS China PMCF Study

Edwards Lifesciences

Status: Active, not recruiting

Conditions: Aortic Valve Replacement

Treatments: Device: EDWARDS INSPIRIS RESILIA Aortic Valve

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05404880

2021-09

Details and patient eligibility

About

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.

Full 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 implantation. Stage 2 is additional follow-up through 10 years upon authority's feedback if needed.

Enrollment: 255 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

255 participants in 1 patient group

EDWARDS INSPIRIS RESILIA Aortic Valve

Description:

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

Treatment:

Device: EDWARDS INSPIRIS RESILIA Aortic Valve