πŸ›οΈ Verified NIH Record β€’ Updated 2026-04-16

PERIGON Pivotal Trial (NCT02088554)

Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease

πŸ”΅ Active, Not Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: Medtronic Cardiac Surgery

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

To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.

Who can join: Review the eligibility criteria below.

Location: University of Southern California (USC) University Hospital β€” Los Angeles, California

Age range: 18 Years

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

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

πŸ“ All Participating Trial Locations (38 Sites)

Showing the first 25 of 38 sites.

  • University of Southern California (USC) University Hospital β€” Los Angeles, California
  • University of Colorado Hospital β€” Aurora, Colorado
  • Hartford Hospital β€” Hartford, Connecticut
  • University of Florida Shands β€” Gainesville, Florida
  • Piedmont Hospital β€” Atlanta, Georgia
  • University of Maryland Medical Center β€” Baltimore, Maryland
  • Massachusetts General Hospital β€” Boston, Massachusetts
  • University of Michigan Cardiovascular Center β€” Ann Arbor, Michigan
  • Minneapolis Heart Institute Foundation β€” Minneapolis, Minnesota
  • Maimonides Medical Center β€” Brooklyn, New York
  • The Mount Sinai Medical Center β€” New York, New York
  • New York-Presbyterian Hospital/Columbia University Medical Center β€” New York, New York
  • Cleveland Clinic β€” Cleveland, Ohio
  • Riverside Methodist Hospital (OhioHealth) β€” Columbus, Ohio
  • ProMedica Toledo Hospital β€” Toledo, Ohio
  • Oklahoma Heart Hospital β€” Oklahoma City, Oklahoma
  • Cardiothoracic and Vascular Surgeons (CTVS) β€” Austin, Texas
  • Houston Methodist Hospital β€” Houston, Texas
  • University of Washington Medical Center β€” Seattle, Washington
  • Aurora Saint Luke's Medical Center β€” Milwaukee, Wisconsin
  • London Health Sciences Centre - University Campus β€” London, Ontario
  • University of Ottawa Heart Institute β€” Ottawa, Ontario
  • Montreal Heart Institute β€” Montreal, Quebec
  • Institut Universitaire de Cardiologie et de Pneumologie de QuΓ©bec (IUCPQ) β€” QuΓ©bec,
  • Toronto General Hospital β€” Toronto,

πŸ’° 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 Β§ 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.

Explore by condition: All Aortic Stenosis clinical trials

πŸ’‘ 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.
πŸ›οΈ View Official NIH Record β†—