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

NCT04902053 | Suspended FDA Device

• 1 other identifier: 2017-12
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 7

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.

Conditions

Aortic Valve Replacement

Keywords

INVIVITY; RESILIA; INSPIRIS; Valve in Valve; TAVR; Aortic Transcatheter

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Subject's Occurrence Rate of Reportable Adverse Events

  Events occurring within 30 days of valve-in-valve procedure

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• years or older at the time of the TAVR ViV treatment
• Has an INSPIRIS RESILIA aortic valve implanted in the aortic position confirmed to be size 19mm, 21mm, 23mm or 25mm
• A ViV procedure using an Edwards transcatheter aortic heart valve (TAVR) has been scheduled; or completed within 37 days from time of consent
• The participant agrees to attend a follow-up assessment at 1 month post ViV procedure
• The participant provides written informed consent prior to the post-ViV procedure CT scan

You may not qualify if:

• The INSPIRIS RESILIA aortic valve size is
• Unconfirmed, or
• Confirmed to be 27mm or 29mm
• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (7)

University of Southern California

Los Angeles, California, 90033, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

St. Vincent Hospital

Indianapolis, Indiana, 46290, United States

Location

Nyph/Cumc

New York, New York, 10032, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Douglas Johnston, MD, FACS

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 26, 2021
• Study Start (Estimated): June 1, 2028
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)