Aortic Valve Replacement
Conditions
Keywords
INVIVITY, RESILIA, INSPIRIS, Valve in Valve, TAVR, Aortic Transcatheter
Brief summary
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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTSubjects 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.
Sponsors
Edwards Lifesciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Occurrence Rate of the Composite Safety Endpoint | Events occurring within 30 days of valve-in-valve procedure | 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. |
| Subject's Occurrence Rate of Valve Malpositioning | Events occurring within 30 days of valve-in-valve procedure | 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. |
| Subject's INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure Compared to Baseline | Day 30, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Occurrence Rate of Reportable Adverse Events | Events occurring within 30 days of valve-in-valve procedure | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDouglas Johnston, MD, FACS
Northwestern University
Outcome results
None listed