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Get in Rhythm. Stay in Rhythm.™ View Replays from Atrial Fibrillation Patient Conference Aug 4-6, 2017, in Dallas, TX
Get in Rhythm. Stay in Rhythm.™ View Replays from Atrial Fibrillation Patient Conference Aug 4-6, 2017, in Dallas, TX

FDA Weighs Flexibility In Trials of Heart Treatment

New York Times article on FDA oversight meeting regarding atrial fibrillation clinical trials

September 21, 2007 6:20 AM CT

This NY Times article reports on the September 20, 2007 meeting in which the U.S. Food and Drug Administration heard from a panel of experts about the challenges of conducting atrial fibrillation clinical trials and the need to relax restrictions requiring the comparison of ablations to anti-arrhythmic drug therapy. Companies reported on their difficulty enrolling participants in trials of ablation devices when patients must have first failed with anti-arrhythmia drugs, but if accepted into the trial may find themselves assigned to drugs rather than a procedure. The meeting also discussed the challenges with gathering and interpreting atrial fibrillation treatment data.

As we afib patients know, once you have failed on drugs and are ready for a procedure, drugs become an unacceptable atlernative. No wonder it's so hard to get the results data we need to make informed decisions.

F.D.A. Weighs Flexibility In Trials of Heart Treatment, by Barnaby Feder

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Last Modified September 21, 2007

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