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.
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 valve will be implanted in approximately 20 and at least 15 patients who will be followed for at least 1 year. Patients will be any age and will require this size valve as determined in surgery but will be recruited prior to surgery based on results of preoperative screening tests. Enrollment into the 23mm mitral arm of the study has been terminated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Heart aortic valve replacement surgery: 17mm Aortic
Heart mitral valve replacement surgery: 23mm Mitral
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Maine Medical Center
Portland, Maine, United States
Children's Heart Center Nevada
Las Vegas, Nevada, United States
Number of Valve Related Adverse Events at 1 Year
Number of subjects with a valve related adverse event at 1 year.
Time frame: 1 Year
Diagnosis of Valve Thrombosis at 1 Year
Number of subjects with a diagnosis of Valve Thrombosis at 1 year
Time frame: 1-year
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