ON-X
Clinical Trial of the On-X® Valve Using Low Dose Anticoagulation
The purpose of this study is to define the lowest level of required antithrombotic (anti-blood clot) drug therapy after receiving the On-X heart valve. The On-X heart valve is approved by the Food and Drug Administration (FDA) and is intended for treatment of patients who have been diagnosed with a diseased heart valve, and require replacement of their natural aortic or mitral valve, or previously implanted mechanical or tissue aortic or mitral valve. The study treatment will be similar to that provided to patients who have their heart valves replaced with any other commercially available prosthetic heart valve. This study is a randomized trial of three different antithrombotic drug therapies.