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PERIGON Pivotal Trial — PERIGON  

Aortic Stenosis Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02088554
Study type Interventional
Source Medtronic Cardiac Surgery
Contact
Status Active, not recruiting
Phase N/A
Start date May 12, 2014
Completion date December 31, 2035
View Details
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