On-X Heart Valve - 17mm Aortic and 23mm Mitral
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.
• Patients of any age; unless waived by local IRB assent of the patient and in all cases consent of parent or legally authorized representative is required if a patient is under the age of majority and not legally emancipated.
• Patients who are sufficiently ill to warrant replacement of their diseased natural or prosthetic valve, based on standard cardiovascular diagnostic workups.
• Patients who are in sufficient satisfactory condition, based on the physical exam and investigator's experience, to be an average or better operative risk, (i.e., likely to survive one year postoperatively).
• Patients who require an isolated aortic valve replacement size 17 mm or isolated mitral valve replacement size 23mm.
• Patients who are geographically stable and willing to return to the implanting center for follow-up visits.
• Patients or legally authorized representatives who are adequately informed of their participation in the clinical study and what will be required of them in order to comply with the protocol.
• Patients requiring concomitant cardiovascular surgery, such as coronary bypass may be included in the study.