The Mount Sinai Medical Center has become the first hospital on the east coast to perform a cardiac ablation procedure using the Thermocool Smarttouch Contact Force-Sensing Catheter for the treatment of symptomatic, paroxysmal atrial fibrillation (AF), or periodic rapid and irregular heartbeats. The catheter, combined with 3D mapping and navigation software, gives physicians a real-time, objective measure of tip-to-tissue contact force during the catheter ablation procedure and will hopefully allow physicians to more safely and effectively treat AF, which affects more than two million Americans.
The procedure was performed in July by Vivek Y. Reddy, MD, Professor of Medicine, and Director of the Cardiac Arrhythmia Service at Mount Sinai Heart; Andre d'Avila, MD, Co-Director of the Cardiac Arrhythmia Service; and Srinivas Dukkipati, MD, Director of the Experimental Electrophysiology Laboratory at The Mount Sinai Medical Center. The procedure was part of the SMART-AF Investigational Device Exemption (IDE) clinical trial, which is designed to demonstrate the safety and effectiveness of the Thermocool Smarttouch catheter in the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation.
The Thermocool SmartTOUCH catheter was developed by Biosense Webster, Inc. A growing body of evidence has reinforced the value of force-sensing in improving the effectiveness, safety and accessibility of catheter ablation treatment of cardiac rhythm disorders, including AF.
"At Mount Sinai Heart, we are committed to implementing the latest technologies in treating our patients," said Dr. Reddy. "I am convinced that our ability to visualize and control the catheter-to-tissue contact force during atrial fibrillation ablation procedures will improve our patient outcomes."
In patients with AF, the heart beats irregularly due to abnormal electrical activity in its upper chambers. This irregular beating can cause symptoms such as shortness of breath, fatigue and dizziness, and can ultimately lead to stroke and heart failure. As medications are often ineffective in patients with AF, catheter ablation offers the possibility of more definitive treatment of the arrhythmia.
During catheter ablation, the physician inserts a catheter into the heart to create a series of lesions along the heart wall that disrupt the abnormal electrical activity. With no way to objectively measure the contact force between the catheter tip and beating heart wall, the physician has to estimate - and sometimes guess - the level of force required. Thermocool Smarttouch allows physicians to control how much force is required to create the lesions during ablation procedures. This information is graphically displayed on the Carto® 3 Smarttouch™ Module, a 3D Mapping System, which allows physicians to fully visualize the ablation procedure.
All patients enrolled in SMART-AF will receive treatment with the Thermocool Smarttouch Catheter and will be followed for 12 months by study physicians. Results of SMART-AF will be used to support a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for clearance of the Thermocool Smarttouch catheter and accompanying Carto 3 Smarttouch Module.
Dr. Reddy and his colleagues have long been leaders in this field, and were the first in the United States or the world to use a number of novel technologies, including: the TactiCath catheter, cryoballoon ablation catheter, the visually-guided laser balloon ablation catheter. The team also was the first to perform robotically-guided navigation of ablation catheters for AF ablation.
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