RHYTHMIA

A Randomized, Prospective Multicenter Pilot Study to Assess the Utility and Efficacy of High-Density Mapping with the Rhythmia Mapping System to Guide PV Re-Isolation in Subjects with Recurrent AF After an Initial Cryoballoon PVI Compared to Repeat cryoballoon PVI

Objective

The objective of the study is evaluate the role of high-density EAM with the Rhythmia mapping system and IntellaMap Orion mapping catheter to localize PV reconnection and guide repeat AF ablation with IntellaNav Open-Irrigated (Boston Scientific, Marlborough, MA) or other approved ablation catheters for atrial fibrillation in individuals with recurrent AF following an initial cryoballoon AF ablation and assess the clinical impact in regards to arrhythmia fee survival over 6 months of follow-up compared to repeat cryoballoon PVI. High-density mapping will allow detailed electroanatomic characterization of the patterns of PV reconnection following cryoablation.

Eligibility

  • Individuals with paroxysmal or persistent AF undergoing repeat AF ablation as per recent HRS guidelines and standard practice
  • Individuals in whom the initial ablation approach was cryoballoon PVI more than 3 month or more prior to the anticipated repeat ablation