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A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation


A Randomized, Controlled Clinical Trial of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation.




This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada. Subjects with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy failure of one or more Study Atrial Fibrillation (AF) Drugs (flecainide, propafenone or sotalol) were randomized 2:1 to cryoablation intervention (Experimental Subjects, ES) or to a Study AF Drug (Control Subjects, CS). Subjects were followed for 12 months with scheduled and symptom-driven assessments to detect recurrent atrial fibrillation by means of periodic electrocardiograms, weekly scheduled trans-telephonic monitoring, patient-initiated trans-telephonic monitoring, and 24-hour Holter monitoring at 6 and 12 months. The first 90 days after study therapy was initiated was considered a blanked period for all subjects.

Study Status: Completed


Condition Intervention Phase
Paroxysmal Atrial Fibrillation Device: Arctic FrontĀ® Cryoablation Catheter
Drug: Flecainide or Sotalol or Propafenone
Phase 3

Verified by Medtronic Atrial Fibrillation Solutions July, 2012

Sponsored by: Medtronic Atrial Fibrillation Solutions
Information provided by: Medtronic Atrial Fibrillation Solutions identifier: NCT00523978

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Douglas L. Packer, MD., Principal Investigator

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