ON-X AORTIC PROSTHETIC HEART VALVE LOW DOSE WARFARIN POST APPROVAL CLINICAL REGISTRY STUDY
Heart & Vascular - Cardiac Surgery,
Heart & Vascular
Glenn R. Barnhart, MD
The purpose of the proposed study is to assess the occurrence of bleeding, valve- related thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when targeted at an International Normalized Ratio (INR) level of 1.8 (1.5-2.0 range) during a 5-year follow-up period. The objective will be to compare adverse event rates for patients in subgroups as listed below targeted at 1.8 (range 1.5 to 2.0) per On-X instructions for use to rates from the previous IDE trial (G050208).
Adult patients who have received an On-X aortic prosthetic heart valve implant within 1 year prior to enrolling in the study