Last updated on February 2018

On-X Heart Valve - 17mm Aortic and 23mm Mitral

Brief description of study

This study examines the hemodynamic and hemolytic properties of two additional smaller size valves to the On-X line of valves already approved by FDA.

Detailed Study Description

The purpose of the study is to assess the safety and efficacy of the 17mm On-X Aortic Prosthetic Heart Valve and the 23mm On-X Mitral Prosthetic Heart Valve when used to replace diseased aortic or mitral valves in human subjects.

The On-X 17mm aortic and 23mm mitral valves will be implanted in approximately 20 and at least 15 patients per size and each will be followed for at least 1 year. Patients will be any age and will require these size valves as determined in surgery but will be recruited prior to surgery based on results of preoperative screening tests.

Clinical Study Identifier: NCT01812174

Contact Investigators or Research Sites near you

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Vincent Gaudiani

El Camino Hospital
Mountain View, CA United States
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Recruitment Status: Open

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