SmartFire Study Data at EHRA 2025

The findings showed that the use of the Dual Energy Thermocool Smarttouch SF Catheter was 86.9% effective when patients were treated with high adherence to the recommended ablation parameters. There was also a clinically meaningful improvement in quality of life and reduced healthcare utilization, with a significant reduction in total antiarrhythmic drug (AAD) use observed.

The Dual Energy Thermocool Smarttouch SF Catheter is an irrigated, contact-force sensing catheter powered by the Trupulse Generator, and is fully integrated with the Carto 3 System for advanced electro-anatomical mapping and for tag indexing. The platform is the first dual energy pulsed field ablation (PFA) / radiofrequency (RF) ablation catheter integrated with a PF and RF ablation index, which have proven to be important factors for durable lesion formation. The Dual Energy Thermocool Smarttouch SF Catheter is designed on the familiar platform of the RF Thermocool Smarttouch SF Catheter, with many years of physician experience. It received the European CE Mark approval in December 2024; it is currently investigational in the United States.

SmartfIRE was the first-in-human study assessing the safety and effectiveness of the Dual Energy Thermocool Smarttouch SF Catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation. Primary endpoints were met at the 3-month follow up. The latest findings were observed among eligible participants completing 12-month follow-up, which include: i) · 71.5% 12-month freedom from recurrence with protocol-required stringent monitoring; this rate increased to 86.9% among patients who were treated with high adherence to the recommended ablation workflow; ii) · 3.6% serious adverse device effects (SADE) rate; the SADEs were not classified as related to PF energy; iii) · 40.8% relative reduction in CV-related hospitalizations compared to baseline; iv) · 60.4% relative reduction in Class I/III antiarrhythmic drug use (AAD) compared to baseline, with a significant reduction in total AAD use observed.

“With the global incidence of AFib rising due to an aging population and the increasing prevalence of cardiovascular risk factors, there is a growing need for advanced, integrated technologies that support cardiac ablation procedures with clinical precision, proven efficacy, and optimized procedural efficiency,” said Tom De Potter, M.D., Head of Electrophysiology and Associate Director of the Heart Center, OLV Hospital, Aalst, Belgium. “With an efficacy rate of 86.9% with high adherence to the recommended ablation protocol leveraging the PF & RF Tag Index, the 12-month SmartfIRE data supports the effectiveness, safety, and clinical benefits of ablation performed with the Dual Energy Thermocool Smarttouch SF Catheter.”

About the SmartfIRE Study
SmartfIRE is an open-label interventional study evaluating the safety and efficacy of the investigational Dual Energy Thermocool Smarttouch SF Catheter with the Trupulse Generator, in the treatment of paroxysmal atrial fibrillation. The study enrolled 149 adult patients in Europe with drug refractory paroxysmal AFib, identified as candidates for catheter ablation, to receive PF or RF catheter ablation using the Dual Energy Thermocool Smarttouch SF Catheter and Trupulse generator during their cardiac ablation procedure. The study includes patients experiencing recurrent symptomatic atrial fibrillation following at least one AAD; class I to IV, or patients who can either not tolerate AAD or for whom AAD is contraindicated.

Johnson & Johnson MedTech is also supporting the presentation of real-world evidence data from the company sponsored REAL AF Registry, a database comprised of 68 centers investigating real-world safety and effectiveness of catheter ablation procedures, health outcomes, research, and the future of electrophysiology practice. The data presented from the REAL AF Registry included those that examine gender differences in ablation strategies and outcomes, and outcomes with zero-fluoroscopy vs conventional approaches.

As part of its leadership in research to inform future clinical practice in catheter ablation, Johnson & Johnson MedTech is supporting additional studies with the Dual Energy Thermocool Smarttouch SF Catheter, as well as a number of investigator-initiated collaborative studies. The first patients have been enrolled in the GPfIRE collaborative study evaluating the impact of PF energy, both alone and in combination with RF energy, on vagal modulation after Pulmonary Vein Isolation (PVI) in PAF. Activation of the autonomic nervous system can induce changes to atrial electrophysiology. GPfIRE is designed to assess how ablation with PF and RF energy affects the autonomic nervous system and, in turn, heart rate variability. The first cases were performed by Dr. Tom De Potter at OLV Hospital in Aalst, Belgium.

“At Johnson & Johnson MedTech, we recognize that advancing patient care requires strong collaborations and rigorous clinical research. By supporting studies like GPfIRE, we are committed to generating robust clinical evidence, especially for pulsed field ablation, that not only informs treatment decisions but also drives innovation in AFib care. Our goal is to empower clinicians with the insights needed to enhance workflows and optimize patient outcomes,” said Jennifer Currin, Ph.D., Vice President, Scientific Affairs, Johnson & Johnson MedTech.

In addition to the Dual Energy Thermocool Smarttouch SF Catheter, Johnson & Johnson MedTech is committed to offering a versatile portfolio of PFA products designed for seamless integration. Tools like the Dual Energy Thermocool Smarttouch SF Catheter and the Varipulse Platform work together to create optimal efficiency and compatibility in the treatment of cardiac arrhythmias.