PERIGON Pivotal Trial
Public ClinicalTrials.gov record NCT02088554. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT02088554
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- Medtronic Cardiac Surgery
- Industry
- Enrollment
- 1,312 participants
Conditions and interventions
Conditions
Interventions
- Model 400 aortic valve bioprosthesis Device
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 11, 2014
- Primary completion
- Apr 16, 2023
- Completion
- Dec 30, 2035
- Last update posted
- Apr 28, 2026
2014 – 2035
United States locations
- U.S. sites
- 20
- U.S. states
- 15
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Southern California (USC) University Hospital | Los Angeles | California | 90033-5313 | — |
| University of Colorado Hospital | Aurora | Colorado | 80045-2545 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| University of Florida Shands | Gainesville | Florida | 32610 | — |
| Piedmont Hospital | Atlanta | Georgia | 30309 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan Cardiovascular Center | Ann Arbor | Michigan | 48109-5853 | — |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407-1139 | — |
| Maimonides Medical Center | Brooklyn | New York | 11219 | — |
| The Mount Sinai Medical Center | New York | New York | 10029 | — |
| New York-Presbyterian Hospital/Columbia University Medical Center | New York | New York | 10032 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195-0001 | — |
| Riverside Methodist Hospital (OhioHealth) | Columbus | Ohio | 43214 | — |
| ProMedica Toledo Hospital | Toledo | Ohio | 43606 | — |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73135 | — |
| Cardiothoracic and Vascular Surgeons (CTVS) | Austin | Texas | 78756-4080 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| University of Washington Medical Center | Seattle | Washington | 98195-0001 | — |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215-4330 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02088554, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 28, 2026 · Synced Apr 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02088554 live on ClinicalTrials.gov.