Enrolment completed in SmartfIRE clinical study

Thermocool Smarttouch SF

Biosense Webster has announced that enrolment has been completed in the SmartfIRE study evaluating the safety and efficacy of its investigational Thermocool Smarttouch SF dual energy catheter and investigational Trupulse generator for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (AF) during standard electrophysiology mapping and ablation procedures.

SmartfIRE is a pivotal, prospective, multicentre, single-arm study evaluating Biosense Webster’s dual energy pulsed field (PF) and radiofrequency (RF) ablation system. Since the study’s commencement in February 2023, the trial has enrolled 149 patients with paroxysmal AF across nine centres in Europe. Patients will be assessed for 12 months for safety and efficacy.

“Biosense Webster’s dual energy ablation system has the potential to enable electrophysiologists to eliminate the need to exchange catheters and allow them to seamlessly switch the energy source, whether RF or PF, based on patient needs,” said Gediminas Račkauskas (Vilnius University Hospital Santaros Clinics, Vilnius, Lithuania). “Together with the Carto 3 mapping system that enables real-time catheter visualisation, this system has the potential to drive enhanced safety, efficiency, and effectiveness of ablation procedures, while allowing doctors to utilise a familiar workflow.”

The Thermocool Smarttouch SF radiofrequency catheter has been available in Europe since 2016. The Thermocool Smarttouch SF dual energy catheter with contact force sensing capability is an investigational steerable, multi-electrode luminal, irrigated catheter for PF and RF ablation. The investigational Trupulse generator provides both the RF energy and the novel unipolar, biphasic PF energy to the catheter through the toggling of the two energy sources on the generator monitor.

The Thermocool Smarttouch SF catheter is to be used in this investigational study with the Trupulse generator, to transmit the PF or RF energy to the catheter tip electrode for cardiac ablation. The catheter and the generator are integrated with the Carto 3 system. The Trupulse generator is an investigational device and is not available for sale in the USA or in Europe.

“Given the strong trust and familiarity physicians have with the Thermocool Smarttouch SF catheter and also industry interest in the potential of PFA, we saw a high level of excitement for participation in the SmartfIRE clinical trial,” said Jasmina Brooks, president, Biosense Webster. “This study will contribute to a growing body of evidence being developed by Biosense Webster to support the use of PFA as an additional option for AF treatment, complementing our best-in-class RF ablation catheter portfolio.”


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