Safety and Effectiveness IDE Trial for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation


To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).


  • History of recurrent symptomatic Paroxysmal Atrial Fibrillation, defined as AF that terminates spontaneously or with intervention (either procedure or drug therapy) within seven days of onset. Minimum documentation includes at least two separate AF episodes within 6 months prior to enrollment documented with physician's note. At least one of these episodes must be documented with Holter monitor, rhythm strip, TTM or 12-leads ECG
  • No amiodarone use within 90 days prior to enrollment
  • Subjects who are indicated for an ablation procedure for paroxysmal atrial fibrillation (PAF) according to 2017 HRS expert consensus statement on catheter and surgical ablation of atrial fibrillation
  • Subjects refractory or intolerant to at least one class I or III antiarrhythmic medication

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