Biosense Webster’s Thermocool SmartTouch SF dual-energy catheter enables the use of both radio-frequency (RF) and pulse-field (PF) techniques in catheter ablation procedures. The SmartfIRE pivotal, prospective, multi-center, single-arm study will evaluate such an approach for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (AFib) during standard electrophysiology mapping and ablation procedures.
Minimally invasive catheter ablation treats heart rhythm disorders, including AFib, by interrupting irregular electrical pathways in the heart by delivering either heat (RF ablation) or cold (Cryoablation), according to a press release from Biosense Webster. PF ablation offers a new way to treat AFib, using a controlled electric field to selectively ablate cardiac tissue that causes the irregular heartbeat through a process called irreversible electroporation (IRE). The process may help reduce the risk of damage to surrounding tissues including esophageal, pulmonary vein, and phrenic nerve injury, since it does not rely on thermal effects to ablate target cardiac tissue.
The first procedure using the Thermocool SmartTouch SF dual energy catheter the study was performed by Tom De Potter, MD, FEHRA, associate director, Cardiovascular Center, Department of Cardiology, Electrophysiology Section, OLV Hospital, Aalst, Belgium, and several additional cases were handled by Dr. Mattias Duytschaever at AZ Sint-Jan Brugge Oostende AV in Brugge, Belgium, which is also taking part in the clinical trial.
"While radiofrequency ablation has decades of safety and efficacy data to support it, pulse field ablation is a novel technology that shows promise in advancing the safety and ease of catheter ablation procedures; the versatility of a dual-energy catheter would give electrophysiologists the choice of using either one or both modalities at their fingertips," explained De Potter in the release. "In caring for patients with AFib, my goal is to deliver a treatment that is maximally safe and efficient at the same time, and this dual-energy system may give me the ability to switch between radiofrequency and pulsed field and customize treatment during a procedure to deliver the most appropriate energy.''
SmartfIRE will evaluate Thermocool SmartTouch SF's principal components: the dual-energy catheter and the TruPulse generator. The catheter utillizes bi-directional navigation and contact force sensing for a steerable, multielectrode luminal, irrigated system. The catheter is CE marked for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a RF generator, for cardiac ablation.
In this investigational study, the dual-energy catheter is to be used with the investigational TruPulse generator, which provides both the RF energy and the novel unipolar, biphasic pulse sequence to the catheter through the toggling of the two energy sources on the generator monitor. This transmits the PF or RF energy to the catheter tip electrode for cardiac ablation. The catheter and the generator are integrated with the Carto system.
Neither the Thermocool SmartTouch SF catheter nor the TruPulse generator is available for sale in the United States. The study will enroll approximately 135 patients in Europe.
Last year, Biosense Webster introduced its Octaray Mapping Catheter with Trueref technology powered by the Carto 3 Version 7 System. According to MD+DI, the new cardiac mapping catheter was developed for the mapping of cardiac arrhythmias, including atrial fibrillation (AFib).Â