Single Versus Double Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This is a clinical study where the investigators will assess the efficacy of a single
      cryoballoon application per vein guided by a multipolar recording catheter as compared with a
      conventional technique with 2 cryoballoon applications for pulmonary vein isolation (PVI) in
      patients with atrial fibrillation (AF).
    

Detailed description: 
      This is a prospective, randomized clinical study performed at one centre. The objective is to
      assess the efficacy of a single cryoballoon application per vein guided by a multipolar
      recording catheter as compared with a conventional technique with 2 cryoballoon applications
      for pulmonary vein isolation in patients with atrial fibrillation (AF).

      140 subjects with paroxysmal or persistent atrial fibrillation referred for their first AF
      ablation procedures will be enrolled.

      Recruitment, ablation and follow-up will be performed at Dep of Cardiology in Uppsala
      University Hospital, Uppsala, Sweden.

      Study duration is 2 years with 12--months enrolment period and 1 year follow-up per subject.

      Pulmonary vein isolation (PVI) will be performed using the Arctic Front Advance cryoballoon
      ablation catheter. Patients will be randomized to a single cryoballoon application guided by
      a multipolar recording catheter or to a conventional technique with 2 cryoballoon
      applications. After cryoballoon ablation of all pulmonary veins, PV conduction block will be
      assessed by a separate circular mapping catheter. Acute procedural success is defined as
      complete electrical isolation of a pulmonary vein assessed by entrance and exit block,
      including 20 minutes waiting time. Complications and duration of the procedure will be
      assessed.

      Patients will be followed at three, six and 12 months after the ablation procedure. A 12 lead
      ECG, a 7 day Holter monitoring, quality of life (EQ5D) and EHRA score, will be performed at
      baseline, 6 and 12 months. as well as Biomarkers including nTproBNP and troponin I, will be
      performed at baseline, and at 6 and 12 months (only nTproBNP). Predictive variables for
      successful outcome/AF recurrence will be analysed.

      The frequency of symptomatic recurrence of AF and number of reablations will be compared at 6
      and 12 months, and in those requiring a redo ablation procedure the status of PV reconduction
      will be assessed.
    

Intervention name(s): PVI by single cryoballoon application guided by Achieve Mapping Catheter; PVI by 2 routine cryoballoon applications
Intervention type(s): Device; Device
Intervention description(s): Pulmonary vein isolation by single cryoballoon application guided by recorded electrogram signals from an internal Mapping Catheter and by temperature drop if mapping of signals is not possible (temperature cutoff < or = -40 degrees C); Pulmonary vein isolation by 2 cryoballoon applications guided by degree of occlusion and by temperature drop according to discretion of physician
Other intervention name(s): Arctic Front™ Advance Cardiac CryoAblation Catheter; Achieve Mapping Catheter; Arctic Front™ Advance Cardiac CryoAblation Catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ablation; Cryoballoon; Achieve