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PERIGON Pivotal Trial | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

PERIGON Pivotal Trial

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

NCT02088554•Medtronic Cardiac Surgery

View on ClinicalTrials.gov

Summary

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

Detailed Description

This is a prospective, interventional, non-randomized, worldwide, multi-center trial. A maximum of 1300 subjects were to be implanted at a maximum of 40 sites in the US, Europe and Canada. The trial includes male and female patients of legal age to provide informed consent in the country where they enrolled in the trial, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Subjects are followed out to 5 years, and select sites follow subjects out to 12 years. Enrollment closed on 14Jul2017 for all valve sizes. Enrollment was reopened in Apr2019 for the 29mm valve size at a subset of US and Canadian sites to obtain greater patient numbers required by the FDA to support US commercial approval of this valve size. Enrollment for the 29mm valve size closed on 14Feb2023.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient has moderate or greater aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:
•i. Left atrial appendage (LAA) ligation ii. CABG (coronary artery bypass grafting) iii. Patent foramen ovale (PFO) closure iv. Ascending aortic aneurysm or dissection repair not requiring circulatory arrest v. Resection of a sub-aortic membrane not requiring myectomy
•2. Patient is geographically stable and willing to return to the implanting site for all follow-up visits
•3. Patient is of legal age to provide informed consent in the country where they enroll in the trial
•4. Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial

Exclusion Criteria

•1. 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
•2. Patient has had previous implant and then explant of the Model 400 aortic valve bioprosthesis
•3. Patient presents with active endocarditis, active myocarditis or other systemic infection
•4. 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)
+16 more criteria

Locations (38)

University of Southern California (USC) University Hospital

Los Angeles, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

University of Florida Shands

Gainesville, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan Cardiovascular Center

Ann Arbor, Michigan, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Maimonides Medical Center

Brooklyn, New York, United States

Key Dates

Start Date

May 12, 2014

Primary Completion Date

April 17, 2023

Completion Date

December 31, 2035

Last Updated

October 16, 2025

Enrollment

1,312

ACTUAL participants

Conditions

Aortic Stenosis

Interventions

Model 400 aortic valve bioprosthesis

DEVICE

Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

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Aortic Stenosis Treated With TAVIAortic Diseases

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Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)

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Aortic Stenosis With Bicuspid Valve

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PERIGON Pivotal Trial

Inclusion Criteria

Exclusion Criteria

Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)

Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System

Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.

Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement

Impact of Enhanced Information on Subjective Information Level and PROMs in Patients with Aortic Stenosis