Biosense Webster has announced the first patient cases with the investigational dual energy Thermocool Smarttouch SF catheter took place as part of the SmartPulse pivotal study for treatment of paroxysmal atrial fibrillation (AF).
The first procedures were performed by David Newton (Memorial Health University Physicians Heart Care, Savannah, USA) and Andrea Natale (St David’s Medical Center, Austin, USA).
The Dual Energy Thermocool Smarttouch SF Catheter (Dual Energy STSF) is an investigational focal, contact force sensing catheter able to deliver both RF and PFA energy. The investigational Trupulse generator provides both the radiofrequency (RF) energy and pulsed field ablation (PFA) energy to the catheter through the toggling of the two energy sources on the generator monitor.
The catheter and the generator are integrated with the Carto 3 mapping system to enable accurate 3D visualisation with minimal fluoroscopy for electrophysiologists (EPs) and their staff. Additionally, this platform integrates parameters such as contact force measurement and ablation indexes for RF and PFA which have proven in preclinical studies to be critical for lesion creation.
SmartPulse is a prospective, single arm, multicentre, clinical evaluation that will enrol approximately 250 patients with paroxysmal AF in the USA to evaluate the safety and effectiveness of the Dual Energy STSF catheter.
“The SmartPulse pivotal trial will allow us to learn more about the promise of PFA in paroxysmal AFib. The Dual Energy STSF catheter is an exciting innovation because it allows customisation of treatment by switching between radiofrequency and pulsed field energy,” said Natale, who conducted one of the first patient cases. “The ability to deliver both types of energy via one catheter simplifies the workflow for ablation procedures, while integration with the Carto 3 mapping system enables real-time catheter visualization and feedback on contact force measurements and ablation indexes—important factors for durable lesion formation.”
In July 2023, Biosense Webster announced it completed enrolment of the SmartfIRE study that is evaluating the safety and efficacy of the Dual Energy STSF Catheter for the treatment of drug refractory symptomatic paroxysmal AF in Europe.
“The Thermocool Smarttouch SF catheter is the most commonly used ablation catheter globally. By bringing the benefits of RF and PFA to a single catheter that EPs are accustomed to, we are giving physicians control of their preferred energy source and offering a point-by-point workflow that many prefer,” said Jasmina Brooks, president, Biosense Webster. “SmartPulse is the latest study in a robust global clinical trial program for the Biosense Webster investigational PFA portfolio aimed at ensuring our differentiated platform gives EPs the tools and information they need in real-time to deliver the best possible patient care.”
