CryoLife® 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.

PROACT PAS

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.

PROACT Mitral

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.

PROACT Xa

A Trial to Determine if Participants with an On-X Aortic Valve Can Be Safely Maintained On Apixaban

Currently, warfarin is the only approved anticoagulation for patients with mechanical valves.1 The purpose of this study is to determine if participants with an On-X Aortic Valve can take apixaban oral medication that does not require INR measurement.2

On-X Heart Valve Clinical Milestones

  • 5

    2001

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

  • 4

    2002

    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

    2006

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

  • 4

    2009

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

  • 5

    2015

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

  • 4

    2017

    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

    2020

    Enrollment in PROACT Xa Clinical Trial commences to determine if participants with On-X Aortic Valve can take apixaban oral medication instead of warfarin.

  • 5

    2020

    Enrollment complete for Mitral Arm of PROACT.

Click Here to View References
Q

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.

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