1. Primary adverse events within 7 days of initial ablation, included pericarditis, myocardial infarction, cardiac tamponade/perforation, thromboembolism, stroke or cerebrovascular accident, transient ischemic attack, phrenic nerve paralysis, or major vascular access complication/bleeding, as well as death, PV stenosis, and atrioesophageal fistula that occurred later than 7 days post-procedure. All safety events were adjudicated by an independent clinical endpoint committee​
  2. The 12-month effectiveness is based on the 83 participants that completed 12-month follow-up at the time of the prespecified interim analysis.​
     
  1. Ablation recommendation: at least 12 applications per PV (translates to 48 applications per participant).​​
Figures adapted from Duytschaever M, et al. Circ Arrhythm Electrophysiol. 2023;16(3):e011780 under the CC BY license.
 


Patient Eligibility Criteria

  1. ECG was conducted per each site’s standard-of-care practice; it was not mandated by the protocol to be completed on every visit.​