NCT02686814

PERIGON Japan Trial

A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the 17mm MDT-2215 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Medtronic Cardiac Surgery · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.

Detailed description

This is a prospective, interventional, non-randomized, multi-center trial, with each site following a common protocol in Japan. A maximum of 20 subjects will be implanted at a maximum of 10 sites in Japan. The trial will include male and female patients of legal age to provide informed consent in Japan, 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. This clinical trial information was submitted voluntarily under the applicable law and therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CRF 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act of 42 CRF 11.24 and 11.44.)

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	17mm MDT-2215 aortic valve bioprosthesis

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-05-01
• Completion: 2022-07-15
• First posted: 2016-02-22
• Last updated: 2024-04-12
• Results posted: 2024-04-12

Locations

10 sites across 1 country: Japan