INVIVITY: INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This is a prospective, observational, non-blinded cohort study with no active concurrent control.
At least fifty (50) Subjects with dysfunctional 19mm-25mm INSPIRIS aortic valves, who are determined to need ViV placement of an approved Edwards transcatheter aortic heart valve, will participate in this study. Sizes 27mm and 29mm valves are not candidates for surveillance under this protocol.
All subjects will be followed for up to 3 months after the TAVR ViV procedure.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 average INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure Compared to Baseline [Discharge or day 7, whichever comes first, compared to baseline]
A primary effectiveness endpoint is the average expansion, measured in mm, of INSPIRIS valve for sizes 19mm-25mm, following the Edwards transcatheter aortic valve implantation.
- Subject's average INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure Compared to Baseline [3 months compared to baseline]
A primary effectiveness endpoint is the average expansion, measured in mm^2, of INSPIRIS valve for sizes 19mm-25mm, following the Edwards transcatheter aortic valve implantation.
- Subject's median INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure Compared to Baseline [Discharge or day 7, whichever comes first, compared to baseline]
A primary effectiveness endpoint is the median expansion, measured in mm^2, of INSPIRIS valve for sizes 19mm-25mm, following the Edwards transcatheter aortic valve implantation.
- Subject's median INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure Compared to Baseline [3 months compared to baseline]
A primary effectiveness endpoint is the median expansion, measured in mm^2, of INSPIRIS valve for sizes 19mm-25mm, following the Edwards transcatheter aortic valve implantation.
- Subject's minimum INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure [Discharge or day 7, whichever comes first]
The primary effectiveness endpoint is the minimum expansion of INSPIRIS valve, measured in mm^2 for sizes 19mm-25mm, following the Edwards transcatheter aortic valve implantation.
- Subject's minimum INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure [3 months]
The primary effectiveness endpoint is the minimum expansion of INSPIRIS valve, measured in mm^2 for sizes 19mm-25mm, following the Edwards transcatheter aortic valve implantation.
- Subject's maximum INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure [Discharge or day 7, whichever comes first.]
The primary effectiveness endpoint is the maximum expansion of INSPIRIS valve, measured in mm^2 for sizes 19mm-25mm, following the Edwards transcatheter aortic valve implantation.
- Subject's maximum INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure [3 months]
The primary effectiveness endpoint is the maximum expansion of INSPIRIS valve, measured in mm^2 for sizes 19mm-25mm, following the Edwards transcatheter aortic valve implantation.
- Subject's 95% confidence interval for the INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure [Discharge or day 7, whichever comes first]
The primary effectiveness endpoint is the 95% confidence interval of the expansion of INSPIRIS valve for sizes 19mm-25mm, following the Edwards transcatheter aortic valve implantation.
- Subject's 95% confidence interval for the INSPIRIS RESILIA Valve Expansion Post Valve in Valve [3 months]
The primary effectiveness endpoint is the 95% confidence interval of the expansion of INSPIRIS valve for sizes 19mm-25mm, following the Edwards transcatheter aortic valve implantation.
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects must meet all of the following Inclusion Criteria:
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18 years or older at the time of the scheduled TAVR ViV treatment
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Currently has an INSPIRIS RESILIA aortic valve implanted in the aortic position confirmed to be size 19mm, 21mm, 23mm or 25mm
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An in situ INSPIRIS RESILIA aortic valve is determined to be experiencing valve dysfunction for which Valve-in-Valve (ViV) treatment is indicated
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A ViV procedure using an Edwards transcatheter aortic heart valve (TAVR) FDA-approved for ViV has been scheduled
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The participant agrees to attend all follow-up assessments for up to 3 months post ViV procedure
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The participant provides written informed consent
Exclusion Criteria:
Subjects must not meet any of the following Exclusion Criteria:
- The INSPIRIS RESILIA aortic valve size is
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Unconfirmed, or
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Confirmed to be 27mm or 29mm
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Prior re-interventions have been performed on the INSPIRIS RESILIA aortic valve
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The INSPIRIS RESILIA aortic valve has been subjected to balloon aortic valvuloplasty (BAV) prior to the baseline quantitative area measurement of the valve area
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The Subject is pregnant or desires to become pregnant within 120 days of the ViV procedure
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Subjects with a known contraindication or hypersensitivity to contrast media that cannot be adequately pre-medicated per hospital guidelines
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Southern California | Los Angeles | California | United States | 90033 |
| 2 | University of Florida | Gainesville | Florida | United States | 32611 |
| 3 | AdventHealth Orlando | Orlando | Florida | United States | 32803 |
| 4 | St. Vincent Hospital | Indianapolis | Indiana | United States | 46290 |
| 5 | Nyph/Cumc | New York | New York | United States | 10032 |
| 6 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 7 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Edwards Lifesciences
Investigators
- Principal Investigator: Douglas Johnston, MD, FACS, The Cleveland Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-12