ICE: Intracardiac Ultrasound Within the Left Atrium During Radiofrequency Ablation of Nonvalvular Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of
      Radiofrequency Ablation of Atrial Fibrillation
    

Detailed description: 
      Atrial fibrillation is the most common rhythm disturbance affecting the human population.

        1. Its prevalence increases with age and can be found in >8% of humans over the age of
           eighty;

        2. Radiofrequency ablation for drug refractory nonvalvular atrial fibrillation has become a
           common therapy available to patients. It has been shown to be both efficacious and cost
           effective;

        3. The standard approach to atrial fibrillation involves electrical isolation of the
           pulmonary veins (PVI) from the rest of the atrium chamber. This involves moving a 3.5mm
           tip ablation catheter point to point around the PV structures until an encircling
           ablation line is formed. This can be made difficult by not knowing if the tip is in good
           contact with the atrial tissue. In addition the esophagus is a posterior lying structure
           and injury to the esophagus by ablating the overlying tissue has been reported, at times
           fatal;

        4. Currently, intracardiac imaging of the left atrium has FDA approval in the right atrial
           chamber. This leads to difficulty in visualizing tip tissue interface, and important
           left sided structures such as carina, ligaments, and esophagus. By placing the tip of
           the ICE catheter in the left atrium, enhanced visualization of the tip tissue interface
           may lead to more effective ablation points, fewer needed ablation points, and enhanced
           safety by avoiding placement over adjacent noncardiac structures.
    

Intervention name(s): Biosense Webster irrigated tip catheter; Biosense Webster irrigated tip catheter; Pulmonary vein isolation; ICE catheter placed through one of two existing 8F sheaths
Intervention type(s): Device; Device; Procedure; Procedure
Intervention description(s): The second group (study group) will have the ICE catheter placed through one of two existing 8F sheaths already in the left atrium. The ICE catheter will be exchanged in the sheath utilizing the lasso multipolar mapping catheter during left pulmonary vein ablation lines. During exchange, suction and irrigation techniques will be utilized to avoid any air or thrombus embolization. All patients will have standard anticoagulation during the procedure with heparin infusion adjusted to an activated clotting time (ACT) of 350-400. The left sided ICE catheter will be adjusted to visualize left sided structures, ablation tip and tissue interface, and adjacent noncardiac structures such as the esophagus during radiofrequency ablation of the left pulmonary vein system.; Group 1 will receive standard pulmonary vein isolation (PVI) procedure utilizing intracardiac guided ultrasound (ICE) placed within the right atrium via the femoral vein.
Other intervention name(s): 3.5mm Biosense Webster irrigated tip catheter.; 3.5mm Biosense Webster irrigated tip catheter.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial Fibrillation