SHS_300270 BARG CONX 14075

Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT)

This is a longitudinal, randomized (randomization to occur at the 3 month follow-up) study comparing the On-X valve on low dose anticoagulation (test group) to concomitant control groups of On-X valves receiving standard Coumadin/aspirin therapy, and also to FDA objective performance criteria (OPC) for heart valve replacement. It is a multicenter study consisting of 20 centers in the United States enrolling no more than 1200 patients (200 in each of 6 groups). There are three test arms of the study: low risk aortic valve replacement, high risk aortic valve replacement and mitral valve replacement. Each arm has an equivalent control. Test therapies are: low risk aortic valve replacement - aspirin/Plavix, high risk aortic valve replacement - Coumadin at INR of 1.5 to 2.0 plus aspirin, and mitral valve replacement - Coumadin at an INR of 2.0 to 2.5 plus aspirin. Follow-up will run for 5 years in each patient.

Inclusion Criteria:
•Patients requiring isolated aortic valve replacement (AVR), or isolated mitral valve replacement (MVR).
•AVR patients receiving low dose or antiplatelet only anticoagulation will be divided into groups at low risk and high risk for thromboembolism with all patients being in the low risk group except for patients with the following conditions which place a patient in the high risk group: Chronic atrial fibrillation; Left ventricular ejection fraction < 30 %
◦Enlarged left atrium >50mm diameter; Spontaneous echo contrasts in the left atrium
◦Vascular pathology; Neurological events; Hypercoagulability; Left or right ventricular aneurysm; Lack of platelet response to aspirin or clopidogrel; Women receiving estrogen replacement therapy

Exclusion Criteria:
•Right side valve replacement
•Double (aortic plus mitral) valve replacement
•Patients with active endocarditis at the time of implant
•Previous confirmed or suspected thromboembolic event or thrombophlebitis
Phase IV
Heart and Vascular
Eric Lehr, M.D.
On-X Life Technologies
Andrea Drouhard
  • Swedish Medical Center