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Home » Differences in AF Are Key in Ablation Device Trials
Differences in AF Are Key in Ablation Device Trials
September 30, 2009
When designing clinical trials for surgical ablation devices to treat atrial fibrillation (AF), sponsors should take into account the differences between long-standing persistent AF and symptomatic paroxysmal AF and adjust patient selection criteria and effectiveness assessments accordingly, the FDA’s Center for Devices and Radiological Health (CDRH) says in a draft guidance.