🏛️ Verified NIH Record • Updated 2026-04-16

PERIGON Pivotal Trial (NCT02088554)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ 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: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (27 items).

Location: University of Southern California (USC) University Hospital — Los Angeles, California

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

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve
  • Patient has had previous implant and then explant of the Model 400 aortic valve bioprosthesis
  • Patient presents with active endocarditis, active myocarditis or other systemic infection
  • Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including:
  • Ascending aortic aneurysm or dissection repair requiring circulatory arrest
  • Acute Type A aortic dissection
  • Ventricular aneurysm
  • Porcelain aorta
  • Hostile mediastinum
  • Hypertrophic obstructive cardiomyopathy (HOCM)
  • Documented pulmonary hypertension (systolic \>60mmHg)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (38 Sites)

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

💰 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.
🏛️ View Official NIH Record ↗