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Suspended

NCT Number: NCT04902053

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

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.

Why the study stopped: Lack of enrollment. Study will be restarted when there is sufficient INSPIRIS Valve in Valve case volume to support enrollment.
Suspended

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Key information

Conditions

Aortic Valve Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Southern California, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must meet all of the following Inclusion Criteria:

  • 18 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

Exclusion criteria

Subjects must not meet any of the following Exclusion Criteria:

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Subject's Occurrence Rate of the Composite Safety Endpoint

    Time frame: 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.

  2. Subject's Occurrence Rate of Valve Malpositioning

    Time frame: 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.

  3. Subject's INSPIRIS RESILIA Valve Expansion Post Valve in Valve Procedure Compared to Baseline

    Time frame: 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 outcomes

  1. Subject's Occurrence Rate of Reportable Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Acronym: INVIVITY

Important dates

Study start
2028
Primary completion
2030
Study completion
2031
First posted
May 26, 2021
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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