INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance 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

SUSPENDED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2028-06-30

Study Completion Date

2031-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aortic Valve Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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

Designed to capture Adverse Event information and valve measurement data from dysfunctional INSPIRIS RESILIA aortic valves before and after Valve-in-valve (ViV) treatment.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No