Thermocool Smarttouch SF Catheter Demonstrates High Efficacy in Patients with Atrial Fibrillation
In the SmartfIRE study, the Thermocool Smarttouch SF catheter showed an 86.9% effectiveness rate among patients treated with high adherence to recommended ablation parameters.
One-year data from the SmartfIRE trial show that Johnson & Johnson’s (J&J) dual energy Thermocool Smarttouch SF catheter demonstrated high efficacy in treating drug-refractory symptomatic paroxysmal atrial fibrillation (AFib). According to the company, the catheter combines pulsed field (PF) ablation and radiofrequency (RF) ablation.1
“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, MD, head of electrophysiology, associate director, heart center, OLV Hospital, Aalst, Belgium, in a press release. “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.”
The open-label interventional SmartfIRE study evaluated the safety and efficacy of the Thermocool Smarttouch SF catheter in 149 adults with drug-refractory paroxysmal AFib throughout Europe. Patients underwent either PF or RF catheter ablation using the Thermocool Smarttouch SF catheter and the Trupulse generator. The study also included patients with recurrent symptomatic atrial fibrillation who had previously used at least one antiarrhythmic drug (AAD), could not tolerate an AAD, or for whom an AAD was contraindicated.
Results showed that the catheter achieved an 86.9% effectiveness rate among patients treated with high adherence to recommended ablation parameters. The study also reported a 40.8% reduction in cardiovascular-related hospitalizations and a 60.4% reduction in class I/III AAD use. Approximately 3.6% of patients experienced serious adverse device effects, which were not reported to be related to PF energy.
J&J Medtech is also presenting findings from its 68-center REAL AF Registry, highlighting the safety and effectiveness of catheter ablation, including gender differences in outcomes and comparisons of zero-fluoroscopy vs. conventional approaches. Additionally, it is supporting further studies on the Thermocool Smarttouch SF catheter, including the GPfIRE study, which explores the effects of pulsed field and radiofrequency energy on autonomic modulation and heart rate variability after pulmonary vein isolation in atrial fibrillation patients.1
As AFib prevalence continues to rise, the condition remains a major public health concern. According to the Centers for Disease Control and Prevention, AFib contributed to 232,030 deaths in 2021, with 28,037 classified as the underlying cause. The risk of AFib increases with age and is more common in women, largely due to their longer life expectancy.
Each year, AFib leads to over 454,000 hospitalizations in the United States and contributes to approximately 158,000 deaths, with its mortality rate rising over the past two decades.2 By 2030, the number of Americans living with AFib is projected to reach 12.1 million.3
“At Johnson & Johnson MedTech, we recognize that advancing patient care requires strong collaborations and rigorous clinical research,” said Jennifer Currin, PhD, VP, scientific affairs, J&J MedTech, in the press release. “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.”
References
1. Johnson & Johnson MedTech Presents Pivotal 12-Month Effectiveness and Safety Data from SmartfIRE Study at 2025 EHRA Congress. J&J. March 31, 2025. Accessed April 2, 2025. https://www.jnj.com/media-center/press-releases/johnson-johnson-medtech-presents-pivotal-12-month-effectiveness-and-safety-data-from-smartfire-study-at-2025-ehra-congress
2. About Atrial Fibrillation. CDC. Accessed April 2, 2025. https://www.cdc.gov/heart-disease/about/atrial-fibrillation.html
3. Atrial Fibrillation: Facts, Statistics, and You. Healthline. Accessed April 2, 2025. https://www.healthline.com/health/living-with-atrial-fibrillation/facts-statistics-infographic
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FSP Outsourcing in Clinical Research: Trends and Opportunities
June 9th 2025When drug developers choose the right outsourcing strategies in clinical research, they can gain significant benefits in terms of quality, efficiency, and operational success. In its third annual Functional Service Provider (FSP) Trends Report, Thermo Fisher Scientific’s clinical research business—PPD—gathered insights from 150 global biotech and pharma leaders to determine how FSP models help sponsors address common industry obstacles.
