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.
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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.
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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 complete for Mitral Arm of PROACT.

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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.
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Important Safety Information

Know the Facts

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

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Patient Videos

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

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