Atrial Fibrillation Clinical Trial
Official title:
ICE: Intracardiac Ultrasound Within the Left Atrium During Radiofrequency Ablation of Nonvalvular Atrial Fibrillation
Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of Radiofrequency Ablation of Atrial Fibrillation
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.
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