Last updated on April 2019

PERIGON Pivotal Trial

Brief description of study

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

Detailed Study Description

This is a prospective, interventional, non-randomized, worldwide, multi-center trial, with each site following a common protocol. A maximum of 1300 subjects will be implanted at a maximum of 40 sites in the US, Europe and Canada. The trial will include male and female patients of legal age to provide informed consent in the country where they enroll in the trial, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Patients will be followed and assessed after implant for up to 5 years.

Clinical Study Identifier: NCT02088554

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