On-X PAS

On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study

On-X PAS [NCT02677974]

Description: 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).

Device: On-X Aortic Heart Valve replacement

Primary Investigator: Castillo-Sang

Drug/Device Information
To assess the occurrence of bleeding, valve related thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when targeted at an INR level of 1.8 (1.5-2.0 range)
5-year follow-up period
Patients will be under standard anticoagulation INR 2.5 (2.0-3.0 range) for at least 3 months before initiation of low dose INR 1.8 (1.5-2.0 range) anticoagulation treatment
Non randomized, observational single arm study
ON-X Life Technologies, Inc.