On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Who Is on the Research Team?
Goeff Tsang, MBChB
Principal Investigator
Southampton University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Treatment
Patients are under standard anticoagulation (INR 2.5) for at least 3 months before initiation of low dose anticoagulation treatment
Treatment
Participants receive low dose warfarin anticoagulation with an INR target of 1.5 to 2.0, with or without home monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- On-X Aortic Heart Valve replacement
Find a Clinic Near You
Who Is Running the Clinical Trial?
On-X Life Technologies, Inc.
Lead Sponsor
North American Science Associates Inc.
Collaborator