Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter

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.

Inclusion criteria

• Documented paroxysmal atrial fibrillation
• ≥18 and ≤75 years of age
• Failure of one or more antiarrhythmic drugs
• Referral for a pulmonary vein isolation catheter ablation procedure to treat atrial fibrillation

Exclusion criteria

• Previous ablation of atrial fibrillation
• Documented left atrial thrombus
• Irregular pulmonary vein anatomy according to transesophageal echocardiography
• Atrial fibrillation secondary to reversible cause
• Amiodarone therapy in the previous 6 months
• Cardiac surgery within the prior 6 months
• Myocardial infarction within the previous 2 months
• Ejection fraction < 40%
• NYHA class III or IV
• Moderate to severe valvular heart disease
• Previous valve replacement
• Pacemaker or implantable cardioverter defibrillator placement in the prior 3 months
• History of stroke or TIA within the previous 12 months
• Left atrial size ≥ 50 mm
• Contraindication for anticoagulation medication
• Life expectancy of less than 12 months
• Pregnancy