A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Medtronic Atrial Fibrillation Solutions Medtronic Cardiac Rhythm and Heart Failure