INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study

Aortic Valve Replacement Clinical Trial

— INVIVITY  

Official title:

INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04902053
• Other study ID #: 2017-12
• Status: Suspended
• Start date: June 2028
• Est. completion date: January 2031

Study information

• Verified date: August 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: January 2031
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Replacement

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Florida	Gainesville	Florida
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	University of Southern California	Los Angeles	California
United States	Nyph/Cumc	New York	New York
United States	AdventHealth Orlando	Orlando	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Subject's average INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure 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.	Day 30, compared to baseline
Secondary	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