CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation

CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation

The aim of the study is to compare the acute procedure and safety outcomes as well as long term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).

Inclusion Criteria:

• Patient must not have undergone a previous ablation for the treatment of PAF
• AF Type - Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) where PAF is defined as recurrent (two or more) episodes of AF that terminate spontaneously in less than seven days, usually less than 48 hours

Exclusion Criteria:

• Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
• Diagnosed with persistent atrial fibrillation defined as recurrent episodes lasting more than 7 and less than 365 days
• More than 4 electrical cardioversions in the year prior to enrollment but not including cardioversions performed within 48 hours of arrhythmia onset
• Documented left atrial thrombus on imaging
• Cannot be removed from anti-arrhythmic drugs for other reasons than atrial fibrillation
• New York Heart Association (NYHA) functional Class III or Class IV heart failure
• Left ventricular ejection fraction < 30%
• Left atrial size > 55 mm as measured in the parasternal antero-posterior view
• Myocardial infarction within 60 days prior to enrolment
• Woman of childbearing potential who is pregnant, lactating or not using adequate birth control