INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study (INVIVITY)

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.

Study Overview

• Status: Suspended
• Conditions: Aortic Valve Replacement
• Intervention / Treatment: Diagnostic test: Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve 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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Hospital
  • New York
    • New York, New York, United States, 10032
      • Nyph/Cumc
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Douglas Johnston, MD, FACS, Northwestern University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2028
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: TAVR; INVIVITY; RESILIA; INSPIRIS; Valve in Valve; Aortic Transcatheter
• Other Study ID Numbers: 2017-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes