Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures

Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (REAFFIRM)

The study is a prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM procedures followed by conventional ablation including PVI versus a standard PVI procedure for the treatment of persistent atrial fibrillation (AF).

Key Inclusion Criteria:

• At least two (2) documented episodes of persistent atrial fibrillation during prior 3 months
• Refractory, intolerant, or contraindicated to Class I or III anti-arrhythmic medications
• Left atrial diameter < 6.0 cm

Key Exclusion Criteria:

• Previous AF Ablation
• Presence of structural heart disease
• New York Heart Association (NYHA) Class IV.
• Ejection fraction < 35%.
• History of myocardial infarction (MI) within the past three months.