Ablation or Surgery for Atrial Fibrillation (AF) Treatment

Atrial Fibrillation is the most common cardiac arrhythmia, affecting millions of people around the world. It is a large burden on health care resources and may even lead to a shorter life expectancy. Drug treatment has been found insufficient and sometimes even hazardous to the pt. Traditionally, there was only one invasive approach available, being MAZE 3 procedure by means of full open chest cardiac surgery. This was a very invasive approach, limited to only a few skilled surgeons, with insufficient options to treat large pt volume.

With the discovery that AF often is initiated and maintained by electrical instability inside and around the Pulmonary Veins, catheter ablation is now a widely accepted early invasive strategy to cure AF. Success rates of 60% to 90% have been reported, depending on technique employed and the type of AF (Resp, chronic versus paroxysmal)

Inclusion criteria

• Patient has a history of symptomatic paroxysmal and/or persistent atrial fibrillation for at least 12 months
• Patient is refractory to or intolerant of at least one antiarrhythmic drug
• Patient has an enlarged atrium >40 mm and/or Patient has a failed previous catheter ablation and/or Patient has additional risk factors such as hypertension, increasing age
• Patient is between 30 and 70 years of age
• Patient is mentally able and willing to give informed consent

Exclusion criteria

• Cardiac ablation or surgical cardiac procedure in the last 3 months
• Previous cardiac tamponade
• Previous stroke or TIA
• Left atrial thrombus
• Left atrial size >65 mm
• Left ventricular ejection fraction <45 %
• Active infection or sepsis
• Pregnancy
• Unstable angina
• Myocardial infarction (MI) within previous 3 months
• Atrial fibrillation is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause
• History of blood clotting abnormalities
• Known sensitivity to heparin or warfarin
• Life expectancy is less than 12 months
• Patient is involved in another clinical study involving an investigational drug or device
• Pleural adhesions
• Prior thoracotomy
• Prior cardiac surgery
• Elevated hemi diaphragm