๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-20

Avalus Ultra Post-Approval Study (PAS) (NCT06506903)

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Medtronic Cardiac Surgery

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease.

Who can join: Review the eligibility criteria below.

Location: Hartford Hospital โ€” Hartford, Connecticut

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (15 Sites)

  • Hartford Hospital โ€” Hartford, Connecticut
  • University of Florida Shands โ€” Gainesville, Florida
  • Emory Saint Joseph's โ€” Atlanta, Georgia
  • WellStar Kennestone Hospital โ€” Marietta, Georgia
  • Northwestern Memorial Hospital โ€” Chicago, Illinois
  • University of Michigan Health System - University Hospital โ€” Ann Arbor, Michigan
  • Mayo Clinic โ€” Rochester, Minnesota
  • St. Joseph's Hospital Health Center โ€” Syracuse, New York
  • UH Cleveland Medical Center โ€” Cleveland, Ohio
  • ProMedica Toledo Hospital โ€” Toledo, Ohio
  • UPMC Presbyterian โ€” Pittsburgh, Pennsylvania
  • Heart Hospital of Austin โ€” Austin, Texas
  • CHI Saint Lukes Health - Baylor Saint Lukes Medical Center โ€” Houston, Texas
  • Houston Methodist Hospital โ€” Houston, Texas
  • Swedish Medical Center Cherry Hill โ€” Seattle, Washington

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก 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.
๐Ÿ›๏ธ View Official NIH Record โ†—