Pradaxa is not for heart valve related a-fib. Why?

8 Jan 2012

You will need to have your cardiologist determine whether your afib is valve related or not. Have you had a stress test or heart catheterization done by your cardiologist since your surgery? The clinical trial that was completed for Pradaxa was to test for non-valvular atrial fibrillation. The reason for this is because non-valvular atrial fibrillation represents approximately 95 percent of all atrial fibrillation cases in the U.S. There will have to be a separate clinical trial that is approved by the FDA for Pradaxa to be approved for use as a medication to treat valvular atrial fibrillation.