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Lack of enrollment. Study will be restarted when there is sufficient INSPIRIS Valve in Valve case volume to support enrollment.
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment. | Diagnostic Test | Designed to capture Adverse Event information and valve measurement data from dysfunctional INSPIRIS RESILIA aortic valves before and after Valve-in-valve (ViV) treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Occurrence Rate of the Composite Safety Endpoint | The primary safety endpoint is a composite endpoint defined as all-cause mortality, all stroke (disabling and non-disabling), life-threatening bleeding, new requirement for dialysis, coronary artery compression or obstruction, major vascular complication, and valve-related dysfunction requiring reintervention. Data will be reported as the number (and percent) of subjects who experience an event divided by the number of enrolled subjects times 100. | Events occurring within 30 days of valve-in-valve procedure |
| Subject's Occurrence Rate of Valve Malpositioning | Valve malpositioning includes all instances of ViV-TAVR migration, embolization, and valve recapture or retrieval. Data will be reported as the number (and percent) of subjects who experience an event divided by the number of enrolled subjects times 100. | Events occurring within 30 days of valve-in-valve procedure |
| Subject's INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure Compared to Baseline | A primary effectiveness endpoint is the expansion, measured in mm^2, of INSPIRIS valve for sizes 19mm-25mm, following the Edwards transcatheter aortic valve implantation. | Day 30, compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Occurrence Rate of Reportable Adverse Events | Reportable Adverse Events mirroring those being reported to the STS/ACC TVT Registry. Data will be reported as the number (and percent) of subjects who experience an event divided by the number of enrolled subjects times 100. | Events occurring within 30 days of valve-in-valve procedure |
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Inclusion Criteria:
Subjects must meet all of the following Inclusion Criteria:
Exclusion Criteria:
Subjects must not meet any of the following Exclusion Criteria:
The INSPIRIS RESILIA aortic valve size is
Prior re-interventions have been performed on the INSPIRIS RESILIA aortic valve
The INSPIRIS RESILIA aortic valve has been subjected to balloon aortic valvuloplasty (BAV) prior to the baseline quantitative area measurement of the valve area
The Subject is pregnant or desires to become pregnant within 40 days of the ViV procedure
Subjects with a known contraindication or hypersensitivity to contrast media that cannot be adequately pre-medicated per hospital guidelines
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Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Johnston, MD, FACS | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| University of Florida |
Individual participant data will not be available to other researchers.
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| Gainesville |
| Florida |
| 32611 |
| United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| St. Vincent Hospital | Indianapolis | Indiana | 46290 | United States |
| Nyph/Cumc | New York | New York | 10032 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |