INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study (INVIVITY)

Edwards Lifesciences

Status: Suspended

Conditions: Aortic Valve Replacement

Treatments: Diagnostic Test: Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment.

Study type: Observational

Funder types: Industry

Identifiers

NCT04902053

2017-12

Details and patient eligibility

About

The primary objective of the INSPIRIS RESILIA Aortic Valve-in-valve (ViV) Surveillance Study ("the Study") is to capture Adverse Event information and valve measurement data from dysfunctional INSPIRIS RESILIA aortic valves before and after Valve-in-valve (ViV) treatment.

Full description

This is a single-arm observational study which includes both prospective and retrospective data.

At least fifty (50) Subjects enrolled prospectively prior to the ViV procedure, or retrospectively after the ViV procedure (within 37 days post-ViV procedure) with dysfunctional 19mm-25mm INSPIRIS aortic valves, will participate in this study.

All subjects will be followed for up to 1 month after the TAVR ViV procedure.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects must meet all of the following Inclusion Criteria:

1. 18 years or older at the time of the TAVR ViV treatment
2. Has an INSPIRIS RESILIA aortic valve implanted in the aortic position confirmed to be size 19mm, 21mm, 23mm or 25mm
3. A ViV procedure using an Edwards transcatheter aortic heart valve (TAVR) has been scheduled; or completed within 37 days from time of consent
4. The participant agrees to attend a follow-up assessment at 1 month post ViV procedure
5. The participant provides written informed consent prior to the post-ViV procedure CT scan

Exclusion criteria

Subjects must not meet any of the following Exclusion Criteria:

1. The INSPIRIS RESILIA aortic valve size is

   • Unconfirmed, or
   • Confirmed to be 27mm or 29mm

2. Prior re-interventions have been performed on the INSPIRIS RESILIA aortic valve

3. The INSPIRIS RESILIA aortic valve has been subjected to balloon aortic valvuloplasty (BAV) prior to the baseline quantitative area measurement of the valve area

4. The Subject is pregnant or desires to become pregnant within 40 days of the ViV procedure

5. Subjects with a known contraindication or hypersensitivity to contrast media that cannot be adequately pre-medicated per hospital guidelines