ποΈ 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
π΅ Active, Not Recruiting Observational / Diagnostic βοΈ Medical Device Protocol Sponsor: Medtronic Cardiac Surgery
π©Ί 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
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π 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,
π° 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.
More studies in Aortic Stenosis
- ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement β Birmingham, Alabama
- PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis β Birmingham, Alabama
- Use of DurAVRβ’ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study β Tucson, Arizona
- Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study) β Edmonton, Alberta
- Systematic Ambulatory ECG Monitoring Following TAVI β QuΓ©bec, Quebec
Explore by condition: All Aortic Stenosis clinical trials
π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.