Comparison of PVI Plus Catheter Ablation or PVI Alone for the Treatment of AFib for Patients With Paroxysmal Atrial Fibrillation

Comparison of Pulmonary Vein Isolation Plus Additional Catheter Ablation or Pulmonary Vein Isolation Alone for the Treatment of Atrial Fibrillation for Patients With Paroxysmal Atrial Fibrillation: A Prospective, Randomized Study

There is a need to compare the efficacy of PVI versus PVI plus catheter ablation, which includes ablation of complex fractionated atrial electrograms (CFAE) and linear lesions in the same procedure. If it is found that the PVI alone is as effective as PVI plus catheter ablation of CFAE and linear lesions, it may reduce the need for catheter ablation.

Inclusion Criteria:

(Step 1 - Registration)

• The subject is 18 years of age or older
• Left atrium < 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view
• performed within 6 months)
• Documentation of AF that terminates spontaneously or with intervention within 7 days of onset (PAF) Failed or refractory to one AAD (class I and/or III)
• Provided written informed consent
• Be eligible for an AF ablation procedure for Paroxysmal AF

(Step 2 - Randomization)

• Sustained AF following PVI with ability to receive additional linear or focal intracardiac catheter ablation

Exclusion Criteria:

(Step 1 - Registration)

• Pregnant or planning to become pregnant during study
• Co-morbid medical conditions that limit one-year life expectancy
• Previous cardiac surgery
• Patients who have active infection or sepsis
• Patients with esophageal ulcers strictures and varices
• Patients who are contraindicated for anticoagulants such as heparin and warfarin
• Patients who are being treated for ventricular arrhythmias
• Patients who have had a previous left atrial catheter ablation for AF (does not
• include ablation for AFL or other supraventricular arrhythmias)
• Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
• Not competent to legally represent him or herself (e.g., requires a guardian or
• caretaker as a legal representative)

(Step 2 Randomization)

• Not able to receive additional linear or focal intracardiac catheter ablation