🏛️ Verified NIH Record • Updated 2026-04-07

Valved Graft PMCF Study (NCT04754217)

Valved Graft Post-Market Clinical Follow-up Study

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Abbott Medical Devices

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

Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.

Who can join: Review the eligibility criteria below.

Location: University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham, Alabama

Age range: 18 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 (25 Sites)

  • University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham, Alabama
  • University of Michigan — Ann Arbor, Michigan
  • Mission Health & Hospitals — Asheville, North Carolina
  • Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania
  • University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
  • Klinik Floridsdorf — Vienna,
  • Rigshospitalet — Copenhagen,
  • CHU de Besancon - Jean Minjoz — Besançon,
  • CHRU Lille — Lille,
  • Groupe Hospitalier Bichat - Claude Bernard — Paris,
  • Herz-und Diabetes Zentrum NRW — Bad Oeynhausen,
  • Deutsches Herzzentrum Berlin — Berlin,
  • Klinikum Links der Weser — Bremen,
  • Medizinische Hochschule Hannover — Hanover,
  • Onassis Cardiac Surgery Center — Athens,
  • Policlinico S.Orsola-Malpighi — Bologna,
  • Ospedale San Raffaele — Milan,
  • Policlinico San Donato — San Donato Milanese,
  • Wojewodzki Szpital Zespolony w Kielcach — Kielce,
  • Krakowski Szpital Specjalistyczny im. Jana Pawla II — Krakow,
  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi — Lodz,
  • The Cardinal Stefan Wyszynski Institute of Cardiology — Warsaw,
  • Hospital Universitario del Vinalopó — Elche,
  • Hospital Universitario Son Espases — Palma de Mallorca,
  • James Cook University Hospital — Middlesbrough,

📞 Contact the Study Coordinator

Phone: +39 335 61 40 573

Email: paolo.amato@abbott.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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. Contact the study coordinator using the phone/email above.
  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 ↗