a. Primary adverse events were defined as myocardial infarction, thromboembolism, transient ischemic attack, diaphragmatic paralysis, pneumothorax, heart block, pulmonary edema, vagal nerve injury, pericarditis, major vascular access complication or bleeding, death, stroke, or any other cerebrovascular accident. Atrioesophageal fistula and PV stenosis occurring >7 days postablation along with cardiac tamponade or perforations occurring within 30 days of the ablation procedure were also considered primary adverse events.
Figures adapted from Duytschaever M, et al. Circ Arrhythm Electrophysiol. 2023;16(3):e011780 and De Potter, et al. Circ Arrhythm Electrophysiol. 2024. doi: 10.1161/CIRCEP.123.012667 under the CC BY license.
d. ECG was conducted per each site’s standard-of-care practice; it was not mandated by the protocol to be completed on every visit.