Substrate Versus Trigger Ablation for Paroxysmal Atrial Fibrillation

Open to people ages 21 years and up

• male or female >21 years
• reported incidence of at least two documented episodes of symptomatic paroxysmal atrial fibrillation (AF) during the three months preceding trial entry (at least 1 episode documented by 12-lead ECG or ECG rhythm strip)
• women without childbearing potential or women of childbearing potential who are not pregnant per a serum HCG test
• refractory to at least one Class I or III anti-arrhythmic medications. Drug doses must be therapeutic and stable
• willingness, ability and commitment to participate in baseline and follow-up evaluations without participation in another clinical trial (unless documented approval received from both sponsors)
• oral anticoagulation required for those subjects who have a score of two or more based on the following criteria (CHAD score):
  • Congestive heart failure (1 point)
  • hypertention (1 point)
  • age 75 years or older (2 points)
  • diabetes (1 point)
  • prior stroke or transient ischemic attack (2 points)
  • vascular disease (1 point)
  • age 65 years or older (1 point)
  • sex category: female (1 point)
• patient is willing and able to remain on anti-coagulation therapy for a minimum of 3 months post procedure for all subjects, and potentially indefinitely post procedure if the patient has CHAD score >or=2
• signed informed consent after a full discussion of the risks and benefits of both therapy arms, and the concept of randomization
• NYHA Class 0,I, II stable on medical therapy for > 3months
• left atrial diameter <or= 5.5cm
• LVEF >or=40%
• sustained AF during the procedure

• atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, pericarditis)
• cardiac or thoracic surgery within the past 180 days
• AF secondary to electrolyte imbalance, thyroid disease
• contraindication to Heparin
• Contraindication to Warfarin or other novel oral anticoagulants
• history of significant bleeding abnormalities
• history of significant blood clotting abnormalities, systemic thrombi or systemic embolization
• ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve
• atrial clot/thrombus on imaging such as on a trans-esophageal echocardiogram (TEE) within 72 hours of the procedure
• intramural thrombus or other cardiac mass that may adversely effect catheter introduction or manipulation
• significant pulmonary embolus within 6 months of enrollment
• acute illness or active systemic infection or sepsis that may ordinarily warrant postponement of the procedure
• history of recent cerebrovascular disease (stroke or TIA) or systemic thromboembolism within < 6 months
• NYHA classes III, IV
• heart failure that is not stable on medical therapy
• pulmonary edema, that may make planned anesthesia or sedation difficult
• stable/unstable angina or ongoing myocardial ischemia
• myocardial infarction (MI) within the past three months
• structural heart disease of clinical significance including:
  • congenital heart disease where the abnormality or its correction prohibit or increase the risk of ablation
  • acquired heart disease that may increase risk of ablation, such as significant ventricular septal defect post myocardial infarction
  • rheumatic valve disease, since this produces a unique AF phenotype
  • extreme left atrial enlargement (LA volume index > 60 ml/m2) in whom PVI has low success and 55 mm baskets are too small for the atria
• cardiac transplantation or other cardiac surgery planned within the 12 month followup period of the trial
• life expectancy less than 12 months (the followup period of the trial)
• significant pulmonary disease (e.g., COPD) or any other disease that significantly increase the risk to the patient from sedation or anesthesia
• untreatable allergy to contrast media
• at time of ablation procedure, clinically significant abnormalities in serum potassium, sodium, magnesium or other electrolytes that affect the suitability of the patient for ablation at that time