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

NCT04902053 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-09-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Douglas Johnston, MD, FACS · Northwestern University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2028-06-30
Primary Completion
2030-12-31
Completion
2031-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04902053 on ClinicalTrials.gov