Artivion™ is active in patient-focused clinical studies for the management of heart valve replacement. You can learn more about the On-X® Heart Valve Clinical Studies below.


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

The purpose of this study is to better understand the incidence of bleeding, valve-related blood clots and valve thrombosis with the On-X Aortic Heart Valve when used with the INR level of 1.8 (1.5-2.0 range)1 during a 5-year follow-up period.


Prospective Randomized On-X  Anticoagulation Clinical Trial Mitral Arm

To determine whether it is safe and effective to manage patients with less aggressive anticoagulation therapy than is currently recommended by ACC/AHA guidelines2 after implantation of the
On-X​ bi-leaflet mechanical heart valve in the mitral position.

On-X Heart Valve Clinical Milestones

  • 5


    US FDA approves On-X Aortic Valve with Standard sewing ring.

  • 4


    US FDA approves On-X Mitral Valve with Standard and Conform-X sewing rings. CE mark approval for Aortic Valve with Conform-X sewing ring.

  • 5


    US FDA approves IDE trial for lowered anticoagulation for the On-X Prosthetic Heart Valves (PROACT).

  • 4


    Enrollment complete in the PROACT Aortic Valve Replacement high-risk aortic patient group.

  • 5


    US FDA approves On-X Aortic Heart Valves with INR 1.5–2.0 after 3 months standard anticoagulation.

  • 4


    2017 AHA/ACC Guidelines include On-X Aortic Valve INR 1.5-2.0 in patients without risk of TE.2,*

    *After 3 months standard therapy.

  • 5


    Enrollment complete for Mitral Arm of PROACT.

Click Here to View References

Clinical Trial References

Clinical Studies

  1. Otto CM, et al. Circulation. 2021;143: doi: 10.1161/CIR.0000000000000923.
  2. Granger C. et al. N Engl J Med 2011; 365:981-992 DOI: 10.1056/NEJMoa1107039.

Important Safety Information

Know the Facts

Your choice of aortic or mitral heart valve can affect how long and how well you live.

Patient Videos

See what other heart valve  patients have to say. Click below to watch videos.

Find a Surgeon

Find an experienced valve replacement surgeon in your area.