Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation (AFLIT-PAF)

• any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy after the initial six months follow-up [ Time Frame: 3 years ] [ Designated as safety issue: No ]
• comparison of the subjective findings of recurrence of AF by the patient through QoL and symptom questionnaires [ Time Frame: 3, 6, 12, 24 and 36 months ] [ Designated as safety issue: No ]
• number of track complications, both acute (during the procedure) and chronic throughout the trial [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
• hospitalization rate during a two and a half year follow-up following the initial six months follow-up [ Time Frame: 3 years ] [ Designated as safety issue: No ]

The purpose of this study is to determine whether catheter ablation is more effective than antiarrhythmic drugs in the early stages of paroxysmal atrial fibrillation. In all the patients a subcutaneous loop recorder will be implanted.

• Catheter ablation
  Intervention: Procedure: Catheter ablation using cryothermia
• No Intervention: Antiarrhythmic drugs
  Three months before starting antiarrhythmic drugs, a subcutaneous loop recorder will be implanted.

Inclusion Criteria:

• Age between 18 and 65
• At least three episodes of paroxysmal atrial fibrillation documented on an electrocardiogram or event recording during the last three years
• Never taken antiarrhythmic drugs or at most a pill in the pocket approach
• Willingness, ability and commitment to participate in baseline and follow-up evaluations

Exclusion Criteria:

• Paroxysmal AF for more than three years
• An episode of atrial fibrillation that lasted more than seven days within the past six months
• Persistent/permanent atrial fibrillation
• Atrial fibrillation from reversible cause (i.e. surgery, hyperthyroidism, pericarditis)
• Documented atrial flutter

• Structural heart disease of clinical significance including:

  • Cardiac surgery within six months of screening
  • Unstable symptoms of congestive heart failure (CHF) including NYHA Class III or IV CHF at screening and/or ejection fraction <30% as measured by echocardiography or catheterization
  • Unstable angina
  • Myocardial infarction within six months of screening
  • Surgically corrected atrial septal defect with a patch or closure device
  • LA size > 40mm
• Any prior ablation of the pulmonary veins
• Enrollment in any other ongoing protocol
• Untreatable allergy to contrast media
• Pregnancy
• Any contraindication to cardiac catheterization
• Prosthetic mitral heart valve
• Poor general health that, in the opinion of the Investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, etc.)
• Contraindication to coumadin or heparin
• History of pulmonary embolus or stroke within one year of screening
• Acute pulmonary edema
• Atrial clot on TEE regardless of the patient's anticoagulation medication status