Abstract: . . .  specify the extent or percentage of narrowing that constitutes stenosis. The importance of adequate and appropriate follow-up of study subjects cannot be overemphasized. Our experience is that many clinical investigators omit or perform incomplete post-procedure testing and evaluations once the procedure has been completed. Results obtained from effective follow-up contribute significantly to the review . . .
. . .  Pappone C, Rosanio S, Augello G, et al. Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation : outcomes from a controlled nonrandomized long-term study. J Am Coll Cardiol 2003;42:18597. 6 Ernst S, Ouyang F, Lober F, et al. Catheter-induced linear lesions in the left atrium in patients with atrial fibrillation . J Am Coll Cardiol . . .
. . .  managed control patients to receive ablation procedures after a pre-specified time (e.g., six months in a control arm). These considerations will allow study sponsors to develop reasonable study designs that facilitate assessment of safety and effectiveness by the FDA consistent with a least burdensome approach to device regulation. Study End Points Primary Effectiveness Endpoint . . .
. . .  vein ablation. J Cardiovasc Electrophysiol 2002;13:764-767. 5 Pappone C, Rosanio S, Augello G, et al. Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation : outcomes from a controlled nonrandomized long-term study. J Am Coll Cardiol 2003;42:18597. 6 Ernst S, Ouyang F, Lober F, et al. Catheter-induced linear lesions . . .
. . .  Anticoagulation We recommend that you explicitly define and explain post-procedure anticoagulation protocols, as currently there is no evidence-based consensus guideline for anticoagulation ollowing percutaneous catheter based AF ablation. f 10 Page 14 Contains Nonbinding Recommendations 11 Study Monitoring In . . .
. . .  circumferential pulmonary vein ablation for atrial fibrillation : outcomes from a controlled nonrandomized long-term study. J Am Coll Cardiol 2003;42:18597. 6 Ernst S, Ouyang F, Lober F, et al. Catheter-induced linear lesions in the left atrium in patients with atrial fibrillation . J Am Coll Cardiol 2003:42:1271-1282.  . . .
. . .  pulmonary vein ablation. J Cardiovasc Electrophysiol 2002;13:764-767. 5 Pappone C, Rosanio S, Augello G, et al. Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation : outcomes from a controlled nonrandomized long-term study. J Am Coll Cardiol 2003;42:18597. 6 Ernst S, Ouyang F, Lober F, et al. Catheter-induced linear . . .
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