PERIGON Pivotal Trial

ClinicalTrials.gov ID: NCT02088554

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.

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ClinicalTrials.gov public records Last synced Oct 23, 2026, 3:16 PM EDT

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

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

Aortic Stenosis

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 12, 2014 (Actual)
Primary completion: Apr 17, 2023 (Actual)
Completion: Dec 31, 2035 (Estimated)
Last update posted: Apr 29, 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 29, 2026 · Synced Oct 23, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02088554 live on ClinicalTrials.gov.

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