A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      STOP AF (PS-023) is a randomized, controlled study of subjects 18 to 75 years old who had
      been referred for ablative intervention after failing one or two (but not all three)
      anti-arrhythmic drugs used in the treatment of AF (flecainide, propafenone and sotalol).
      Study subjects were randomized into two arms: the cryoablation (treatment) arm and the
      membrane-active antiarrhythmic drug (control) arm. A 90- day blanked follow-up period,
      including reablation and medication adjustments was applied in both arms to optimize
      therapies. All subjects underwent follow-up assessments at 1, 3, 6, 9 and 12 months, weekly
      transtelephonic monitoring, 24-hour Holter monitoring and CT/MRI of the pulmonary veins(at 6
      and 12 months) during the trial period. Control subjects who were confirmed to be chronic
      treatment failures were permitted to crossover to cryoablation in this trial.

      Acute procedural success was defined for subjects that underwent cryoablation and
      demonstrated electrical isolation in ≥ 3 Pulmonary Veins (PVs) at the conclusion of the first
      protocol-defined cryoablation procedure using the Arctic Front® Cardiac CryoAblation Catheter
      System.

      The primary effectiveness endpoint was defined as having acute procedural success and freedom
      from chronic treatment failure (CTF) for experimental subjects, and freedom from CTF for
      control subjects. Freedom from (CTF) was defined for both groups as the occurrence of
      detectable AF during a non-blanked follow-up period, or an AF Intervention, or the use of a
      non-study AF drug at any time.

      The co-primary safety outcome measures were Cryoablation Procedure Events (CPEs) in
      cryoablated subjects and Major Atrial Fibrillation Events (MAFEs) in both groups. CPEs were
      device- or procedure-related serious adverse events.

      Other safety assessments were made during the course of the STOP AF trial specific to
      pulmonary vein stenosis (PVS) and phrenic nerve injury.
    

Intervention name(s): Arctic Front® Cryoablation Catheter; Flecainide or Sotalol or Propafenone
Intervention type(s): Device; Drug
Intervention description(s): Experimental Subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci with the cryoablation catheter system.; Flecainide 200 mg / day Propafenone 450 mg / day Propafenone-SR 650 mg / day Sotalol 240 mg / day
Other intervention name(s): Arctic Front® Cardiac CryoAblation Catheter System; Artic Front®; Tambocor; Sotalol; Propafenone
Intervention MeSH terms: Flecainide; Sotalol; Propafenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial Fibrillation