NCT02088554

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,312 (actual)
• Sponsor: Medtronic Cardiac Surgery · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Model 400 aortic valve bioprosthesis

Timeline

• Start date: 2014-05-12
• Primary completion: 2023-04-17
• Completion: 2035-12-31
• First posted: 2014-03-17
• Last updated: 2025-10-16
• Results posted: 2024-06-04

Locations

38 sites across 8 countries: United States, Canada, France, Germany, Italy, Netherlands, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study