PARALELL - Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation
A prospective, two-arm, multi-center, randomized, open-label, pre-market, First-in-Human clinical study designed to provide safety and performance data regarding the use of the Adagio PFA and PFCA Systems in the treatment of PsAF.
• IC 1 Male or female between the ages of 18 - 80 years
• IC 2 Currently scheduled for an ablation of symptomatic persistent (\> 7 days) atrial fibrillation within the past year documented by ECG or Continuous Holter monitoring
• IC 3 Refractory to at least one class I or III AAD. (Refractory defined as not effective or not tolerated)
• IC 4 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study
• IC 5 Willingness and ability to give an informed consent