HVP_2005-01 (PROACT)

Clinical Trial of the On-X® Valve Using Low Dose Anticoagulation

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).

Key Inclusion Criteria:

1. Patients requiring isolated aortic valve replacement (AVR), or isolated mitral valve replacement (MVR).
2. 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

See clinicaltrials.gov for full details.
Phase III/IV
NCT00291525
Heart and Vascular, All Other
Valvular Heart Disease
Emery Douville MD
Medical Carbon Research Institute
Michelle Dixon