🏛️ Verified NIH Record • Updated 2025-06-11

Inspiris Resilia Durability Registry (NCT03666741)

Clinical Outcomes of Patients Under the Age of Sixty Undergoing INSPIRIS RESILIA Aortic Valve Replacement

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Institut für Pharmakologie und Präventive Medizin

🩺 Plain-English Summary (8th-Grade Level)

Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.

Who can join: Review the eligibility criteria below.

Location: University Clinics St. Pölten — Sankt Pölten

Age range: 18 Years to 60 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (21 Sites)

  • University Clinics St. Pölten — Sankt Pölten,
  • Heart Center Hietzing — Vienna,
  • Medical University Vienna — Vienna,
  • KU Leuven — Leuven,
  • Institut de Cardiologie de Montréal, Université de Montréal — Montreal,
  • Laval University — Québec,
  • Hopital de la Timone — Marseille,
  • L'institut du thorax - CHU (Centre Hospitalier Universitaire de Nantes) — Nantes,
  • Centre Hospitalier Universitaire (CHU) de Rennes — Rennes,
  • CHRU - Hospital Trousseau — Tours,
  • UNIVERSITÄTSKLINIKUM FREIBURG, Universitäts-Herzzentrum Herz- und Gefäßchirurgie — Freiburg im Breisgau, Baden-Wurttemberg
  • Heart Center Leipzig — Leipzig,
  • University Hospital Careggi — Florence,
  • Centro Cardiologico Monzino — Milan,
  • European Hospital Rome — Roma,
  • AOU San Giovanni di Dio e Ruggi d'Aragona — Salerno,
  • Erasmus Medisch Centrum — Rotterdam,
  • University Hospital Virgen de la Arrixaca — Murcia,
  • NHS Lothian — Edinburgh,
  • Glenfield Hospital — Glenfield,
  • King's College Hospital NHS Foundation Trust — London,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗