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
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.