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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.
PROACT PAS
On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
PROACT Mitral
Prospective Randomized On-X Anticoagulation Clinical Trial Mitral Arm
On-X bi-leaflet mechanical heart valve in the mitral position.
On-X Heart Valve Clinical Milestones
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2001
US FDA approves On-X Aortic Valve with Standard sewing ring.
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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.
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2006
US FDA approves IDE trial for lowered anticoagulation for the On-X Prosthetic Heart Valves (PROACT).
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2009
Enrollment complete in the PROACT Aortic Valve Replacement high-risk aortic patient group.
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2015
US FDA approves On-X Aortic Heart Valves with INR 1.5–2.0 after 3 months standard anticoagulation.
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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.
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2020
Enrollment complete for Mitral Arm of PROACT.
Clinical Trial References
Clinical Studies
- Otto CM, et al. Circulation. 2021;143: doi: 10.1161/CIR.0000000000000923.
- Granger C. et al. N Engl J Med 2011; 365:981-992 DOI: 10.1056/NEJMoa1107039.
Important Safety Information
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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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Find a Surgeon
Find an experienced valve replacement surgeon in your area.