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Recruiting NCT07120048

Real World Data Collection on the INSPIRIS RESILIA Aortic Valve

— Observational Aortic Valve Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Edwards INSPIRIS RESILIA Aortic Valve.
Who it may be relevant to
Registry conditions: Aortic Valve Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Observational Registry Study Designed to Collect Real-world Hemodynamic and Clinical Outcomes of the INSPIRIS RESILIA Aortic Valve

Overview

Collect real-world data on hemodynamic and clinical outcomes of the INSPIRIS RESILIA Aortic Valve, Model 11500A, in subjects requiring replacement of their native or prosthetic aortic valve as the only heart valve procedure during the index procedure, with or without other concomitant procedures.

Detailed description

Subjects in the INDICATE registry study will be enrolled at up to 20 sites in Germany. Up to 500 subjects will be implanted with the INSPIRIS RESILIA Aortic Valve in this registry.

Interventions

  • Device Edwards INSPIRIS RESILIA Aortic Valve
    Surgical replacement of the aortic valve with the Edwards INSPIRIS RESILIA Aortic Valve

Primary outcome measures

  • Subject's average mean gradient measurement over time [Time frame: Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months]
  • Subject's average peak gradient measurement over time [Time frame: Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months]
  • Amount of aortic transvalvular regurgitation in subjects over time [Time frame: Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months]
  • Amount of aortic paravalvular regurgitation in subjects over time [Time frame: Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months]
Secondary outcome measures (1)
  • Subject's New York Heart Association (NYHA) functional classification at 3 months as compared to baseline. [Time frame: Baseline and 3 months]

Eligibility criteria

Inclusion criteria

  • Patients requiring an aortic valve replacement using the INSPIRIS RESILIA aortic valve according to its intended purpose
  • Patients with standard-of-care pre-procedure imaging evaluation (echocardiography and CT) data available
  • Age ≥ 18 years
  • Provision of written informed consent

Exclusion criteria

  • Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery
  • Emergency procedure
  • Patients requiring a non-aortic heart valve procedure during the index procedure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 14 centers
  • Universitätsklinikum Heidelberg — Heidelberg
  • Rhön Klinikum Campus Bad Neustadt — Bad Neustadt an der Saale
  • Universitätsklinikum Erlangen — Erlangen
  • LMU Klinikum München — Munich
  • TUM Klinikum Deutsches Herzzentrum — Munich
  • Klinikum Passau — Passau
  • Klinikum Oldenburg — Oldenburg
  • Herz- und Diabeteszentrum NRW — Bad Oeynhausen
  • … and 6 more centers

Identifiers

NCT: NCT07120048 · 2025-07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗