Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study

Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study

This investigation is designed with the hypothesis that combined PV Antral Isolation and Ablation of Complex Fractionated Electrograms (PVI+CFE) approach will offer a higher success rate compared to the Wide Circumferential Pulmonary Vein Antrum Isolation (PVI) approach and to the Combined PV Antral Isolation and Empiric Linear Ablation (PVI+Lines) approach.

Inclusion Criteria:

• Patients age is18 years or greater;
• Patients undergoing a first-time ablation procedure for AF;
• Patients with persistent AF;
• Persistent AF will be defined as a sustained episode lasting > 7 days and less than 3 years.
• Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication;
• At least one episode of persistent AF must have been documented by ECG, holter, loop recorder, telemetry, trans telephonic monitoring (TTM), or implantable device within last 2 years of enrollment in this investigation;
• Patients must be able and willing to provide written informed consent to participate in this investigation; and
• Patients must be willing and able to comply with all peri-ablation and follow-up requirements.

Exclusion Criteria:

• Patients with paroxysmal AF;
• Patients with long-standing persistent AF;
• Patients for whom cardioversion or sinus rhythm will never be attempted/pursued;
• Patients with AF felt to be secondary to an obvious reversible cause;
• Patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor;
• Patients with left atrial size ≥ 60 mm (2D echocardiography, parasternal long axis view); and
• Patients who are pregnant.