Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Atrial fibrillation (AF) is the most frequent sustained cardiac arrhythmia,
      impairs quality of life and increases stroke risk and mortality. Recent clinical experience
      with the Arctic Front™ cryoballoon ablation catheter system (Medtronic) suggests that it can
      be used to isolate the pulmonary veins (PVs) safely and effectively in patients with AF,
      thereby eliminating the recurrence of AF.

      Hypothesis: Our hypotheses are (1) that visualization of real-time pulmonary vein conduction
      during cryoballoon ablation of atrial fibrillation using a novel spiral circumferential
      mapping catheter (Achieve™) is feasible and safe, and (2) that procedure and fluoroscopy
      times decrease with experience.

      Objective: The purpose of this study is to assess safety, feasibility, and a learning curve
      associated with cryoballoon catheter ablation using a novel circular mapping catheter
      (Achieve™, Medtronic) inserted through the lumen of the cryoballoon in patients with
      symptomatic paroxysmal atrial fibrillation.

      The primary goal is to evaluate successful pulmonary vein isolation using the Achieve™
      mapping catheter. The reduction of procedure and fluoroscopy times during the first 40
      patients treated with this approach will be analyzed to evaluate a potential learning curve
      upon introduction of the technique.
    

Detailed description: 
      A total of 40 patients scheduled for a first ablation of paroxysmal AF will be included. All
      study subjects will undergo cryoablation using the 28 mm Arctic Front™ Cryoablation Catheter.
      A double transseptal approach will be followed in all study patients, allowing for use of
      regular guide wire and circular mapping catheter, respectively, if required.

      Use of the 20 mm Achieve™ circular mapping catheter is preferred. The 15 mm AchieveTM
      catheter may be used at the physician's discretion. If stable balloon positions cannot be
      obtained, the Achieve™ catheter will be replaced by a regular guide wire and pulmonary vein
      isolation will be assessed by a circular mapping catheter (Lasso™; Biosense Webster)
      introduced through a second transseptal puncture. Cryoablations will be applied for 5 minutes
      each. Premature terminations will be allowed at the physician's discretion but should be
      avoided to allow for detection of late pulmonary vein isolation during cryoenergy
      application. Cryoballoon catheter manipulations (e.g., pull down maneuver) may be performed
      during energy application. During ablation of septal pulmonary veins, electrical phrenic
      nerve stimulation will be performed to exclude phrenic nerve palsy. If additional single
      point ablations are required to achieve electrical isolation of pulmonary veins, a linear
      cryocatheter (Freezor™ Max; Medtronic) will be used.
    

Intervention name(s): Cryoballoon ablation.
Intervention type(s): Procedure
Intervention description(s): Cryoballoon ablation using a novel circular mapping catheter.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial fibrillation; catheter ablation; circular mapping catheter; cryoballoon