TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

It has been hypothesized that the ability to create durable lesions during radiofrequency (RF) ablation is directly correlated with a reduction in the recurrence of arrhythmia in patients with paroxysmal atrial fibrillation (PAF). Lesion depth is directly correlated with the contact force measured between the the tip of the catheter and the heart tissue. In this study, patients in whom a pulmonary vein isolation procedure has been prescribed for the treatment of PAF will be randomized for treatment with either a device incorporating contact force sensing or one without.

To be included in the study, patients 18 or older must demonstrate a history of atrial fibrillation and will have failed treatment using antiarrhythmic medications. In both study arms, ablation will be performed using an accepted treatment strategy and standard procedures. Patients will receive routine follow-up for 12 months after the procedure, with the addition of ambulatory monitoring to detect the recurrence of episodes of atrial arrhythmia. The study will compare the effectiveness of the procedure in the two arms, and will characterize any differences in safety outcomes primarily related to complications arising from the use of an ablation device and the ablation procedure.

Inclusion criteria

• symptomatic PAF refractory to at least one Class I-IV antiarrhythmic drug
• minimum one documented PAF episode >30 sec duration within prior 12 months
• minimum three PAF episodes during prior 12 months
• 18 years or older

Exclusion criteria

• persistent or long-standing persistent AF
• four or more cardioversions in prior 12 months
• MI, CABG or PCI within preceding 3 months
• left atrial diameter > 5.0 cm
• LVEF < 35%
• NYHA class III or IV
• previous left atrial ablation procedure
• previous tricuspid or mitral valve repair surgery