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Ablation for atrial fibrillation (AF) is now one of the most commonly performed cardiac electrophysiology procedures. Most randomized, controlled trials (RCTs) of ablation compare ablation with medical therapy or compare different types of ablation with one another. To address the criticism that a placebo effect may account for much, if not all, of the observed success of ablation in previous studies, researchers conducted a sham-controlled RCT.
One hundred and twenty-six patients (mean age, 67 years; 71% men) with paroxysmal (21%) or persistent (79%) AF were randomized to cryoballoon ablation or a sham procedure, in which catheters were advanced into the heart and phrenic nerve stimulation was performed. All patients received implantable lo…