The Mount Sinai Medical Center has become the first hospital in the United States to perform a cardiac catheterization procedure using the TactiCath force-sensing ablation catheter for the treatment of symptomatic paroxysmal atrial fibrillation (AF), or periodic rapid and irregular heartbeats. The new procedure will allow physicians to more safely and effectively treat AF, which affects more than two million Americans.
The first catheter ablation procedure was performed at the end of February by Vivek Y. Reddy, MD, Professor of Medicine and Director of the Cardiac Arrhythmia Service at Mount Sinai Heart, and his colleagues, Andre d'Avila, MD, Co-Director of the Cardiac Arrhythmia Service, and Srinivas Dukkipati, MD, Director of the Experimental Electrophysiology Laboratory. Dr. Reddy is the national principal investigator on TOCCASTAR (TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation), a clinical trial that is exploring the use of TactiCath for patients who have symptomatic paroxysmal AF and who are resistant or intolerant to at least one anti-arrhythmic drug.
During catheter ablation, the physician inserts a catheter into the heart to create a series of lesions along the heart wall that disrupt 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. TactiCath allows physicians to control how much force is required to create the lesions during ablation procedures. This creates a delicate balancing act between procedure effectiveness and safety, as too little force may render the procedure ineffective and too much force can perforate the heart wall.
"The ability of physicians to control contact force during ablation procedures has long been a missing link in catheter ablation, and the consequence of this has been an historic tradeoff between procedure safety and effectiveness," said Dr. Reddy. "Contact force sensing will likely allow us to more accurately and safely perform the procedure, improving 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. While medications are often ineffective in patients with AF, catheter ablation offers the possibility of more definitive treatment of the arrhythmia.
The TactiCath, developed by Endosense Inc, is the first force-sensing ablation catheter to give physicians a real-time, objective measure of tip-to-tissue contact force during the catheter ablation procedure using fiber optic sensor technology. Based on validated sensor technology, it provides highly accurate and sensitive measurements at the catheter tip. A growing body of evidence has reinforced the value of force sensing in improving patient outcomes of catheter ablation procedures and has supported the TactiCath's potential to improve the effectiveness, safety and accessibility of catheter ablation treatment of cardiac rhythm disorders, including AF.
"Mount Sinai Heart has been a pioneer in heart rhythm disorders," said Valentin Fuster, MD, PhD, Director of Mount Sinai Heart, the Zena and Michael A. Wiener Cardiovascular Institute and the Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, The Mount Sinai Medical Center. "The initiation of this clinical trial at Mount Sinai reflects our continued commitment to leading the charge in the United States in bringing important breakthroughs to the clinical setting."
Patients enrolled in TOCCASTAR will be randomly assigned to receive treatment with either the TactiCath or an alternative FDA-cleared device and will be followed for 12 months by study physicians. Results of TOCCASTAR will be used to support a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for clearance of the TactiCath catheter and accompanying TactiSys system. To enroll or for more information, please call Anaya Abdullah at (212)-241-4313 or email [email protected].
Dr. Reddy and his colleagues have long been leaders in the field, being the first in the United States or the world to use a number of novel technologies including: the cryoballoon ablation catheter, the visually-guided laser balloon ablation catheter, and the first to perform robotically-guided navigation of ablation catheters for AF ablation.
Dr. Vivek Reddy received financial compensation as a consultant for Endosense, the sponsor of this study and the manufacturer of the TactiCath.
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