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πŸ›οΈ Verified NIH Protocol β€’ Sourced via U.S. National Library of Medicine (Last Synced: 2026-04-13)

Valved Graft PMCF Study

🟒 Recruiting Not Applicable πŸ“Š Observational Clinical Research Sponsor: Abbott Medical Devices

🩺 Protocol Summary

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

Primary Research Facility: University Hospital - Univ. of Alabama at Birmingham (UAB) (Birmingham, Alabama)

πŸ“‹ Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

πŸ“ Primary Site Map

Site: University Hospital - Univ. of Alabama at Birmingham (UAB) β€” Birmingham, Alabama

πŸ“ All Participating Trial Locations (25 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. University Hospital - Univ. of Alabama at Birmingham (UAB) β€” Birmingham, Alabama
2. University of Michigan β€” Ann Arbor, Michigan
3. Mission Health & Hospitals β€” Asheville, North Carolina
4. Hospital of the University of Pennsylvania β€” Philadelphia, Pennsylvania
5. University of Pittsburgh Medical Center β€” Pittsburgh, Pennsylvania
6. Klinik Floridsdorf β€” United States
7. Rigshospitalet β€” United States
8. CHU de Besancon - Jean Minjoz β€” United States
9. CHRU Lille β€” United States
10. Groupe Hospitalier Bichat - Claude Bernard β€” United States
11. Herz-und Diabetes Zentrum NRW β€” United States
12. Deutsches Herzzentrum Berlin β€” United States
13. Klinikum Links der Weser β€” United States
14. Medizinische Hochschule Hannover β€” United States
15. Onassis Cardiac Surgery Center β€” United States
16. Policlinico S.Orsola-Malpighi β€” United States
17. Ospedale San Raffaele β€” United States
18. Policlinico San Donato β€” United States
19. Wojewodzki Szpital Zespolony w Kielcach β€” United States
20. Krakowski Szpital Specjalistyczny im. Jana Pawla II β€” United States
21. Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi β€” United States
22. The Cardinal Stefan Wyszynski Institute of Cardiology β€” United States
23. Hospital Universitario del VinalopΓ³ β€” United States
24. Hospital Universitario Son Espases β€” United States
25. James Cook University Hospital β€” United States

πŸ“„ Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

πŸ’° Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act Β§ 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

πŸ’‘ Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

πŸ›οΈ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT04754217 β€’ Last Synced: 2026-04-13
View on ClinicalTrials.gov β†—
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