a. Primary adverse events included death, atrioesophageal fistula, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischemic attack, phrenic nerve injury/diaphragmatic paralysis, heart block, PV stenosis, pulmonary edema (respiratory insufficiency), vagal nerve injury, pericarditis, and major vascular access complication/bleeding. Atrioesophageal fistula and PV stenosis that occurring 7–90 days postablation, and cardiac tamponade/perforation occurring ≤30 days of ablation, were also considered primary adverse events. b. The primary effectiveness endpoint was freedom from documented recurrence of AF/AFL/AT ≥30 seconds and freedom from 3 additional failure modes: acute procedural failure (failure to confirm entrance block in all PVs or use of nonstudy catheter), repeat ablation failure (>2 repeat ablation during blanking period, use of nonstudy catheter for repeat ablation during blanking, or any repeat ablation postblanking), and AAD failure (new AAD/higher dose postblanking).
c. A ±5-point change in AFEQT score is considered a clinically significant change in quality of life.
e. Comparing data from nonrandomized, independent, prospective, single-arm multicenter studies with similar designs: Q-FFICIENCY (n=166, Osorio et al 2023), NAVISTAR THERMOCOOL IDE (n=106, Wilber et al, 2010), SMART-AF (n=160, Natale et al, 2014) and VISTAX (n=329, Duytschaever et al, 2020). The Q-FFICIENCY study safety performance goal was met; the posterior mean of the primary adverse event rate was 4.2%, with a 95% Bayesian credible interval of 1.7% to 7.7%, well below the 14% performance criterion. Based on the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement (Calkins et al, 2017), the primary safety events observed in the Q-FFICIENCY study are in line with what is expected of catheter ablation studies for the treatment of atrial fibrillation.
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