Prospective Randomized On-X Valve Anticoagulation Clinical Trial (PROACT)
US FDA IDE Approved
In January of 2006, the FDA approved the first and only IDE (Investigational Device Exemption) lowered anticoagulation trial for a mechanical valve to be conducted at 40 sites in the United States for the On-X Prosthetic Heart Valve.
PROACT Study Drug Therapy Groups
Low risk aortic patients: clopidogrel plus aspirin (81mg/day)
High risk aortic patients: INR of 1.5-2.0 plus aspirin (81mg/day)
Mitral patients: INR of 2.0-2.5 plus aspirin (81mg/day)
Control groups: American Heart Association/American College of Cardiology standards for mechanical heart valves
Reduction of turbulence provided by a more natural design has lowered complication rates for the On-X Prosthetic Heart Valve.
CAUTION: Federal law restricts this device to sale by or on the order of a physician. Refer to the instructions for use that accompany each valve for indications, contraindications, warnings, precautions and possible complications. CAUTION: This investigational use of this device is limited by Federal law to investigational sites.