Randomized On-X Anticoagulation Trial
Clinical Trial of the On-X® Valve Using Low Dose Anticoagulation
Purpose of Study
The On-X® heart valve, (the prosthesis), is intended for treatment of patients who have been diagnosed with disease of a heart valve, and require replacement of their natural aortic or mitral valve, or previously implanted mechanical or tissue aortic or mitral valve.
The purpose of this study is to define the lowest level of required antithrombotic (anti-blood clot) therapy for the prosthesis. It is a study of three different antithrombotic drug therapies. The therapies include three treatment groups for subjects with:
1) low risk of clotting having an aortic valve replacement,
2) higher risk of clotting having an aortic valve replacement, and
3) mitral valve replacement.
Sponsor: On-X Life Technologies, Inc.
Local Principal Investigator: Vinay Badhwar, MD
Melissa Enlow, RN, MSN
Patients that have been implanted with the On-X heart valve are eligible for enrollment.
For more information, visit ClinicalTrials.gov link.