Biosense Webster Enrolls First Patient in SmartPulse Pivotal Trial of Dual Energy RF+PFA Thermocool Smarttouch SF Catheter for Paroxysmal Atrial Fibrillation

Recently, Biosense Webster announced that the first patient was successfully enrolled as part of the SmartPulse critical study for the treatment of paroxysmal atrial fibrillation (AF), using the investigational dual-energy RF+PFA Thermocool Smarttouch SF catheter.

The first surgery was performed by David Newton from the Heart Care Center at Savannah Memorial Health University in the United States and Andrea Natale from St. David's Medical Center in Austin, USA.

Dual Energy Thermocool Smarttouch SF Catheter (Dual Energy STSF) is an investigational focused contact force sensing catheter capable of delivering both RF and PFA energy simultaneously. The investigational Trupulse generator provides the catheter with radiofrequency (RF) energy and pulsed field ablation (PFA) energy by switching between the two energy sources on the generator monitor.

The catheters and generator are integrated with the Carto 3 mapping system, providing electrophysiologists (EP) and their staff with precise 3D visualization using minimal fluoroscopy. Additionally, the platform incorporates parameters such as contact force measurement and ablation index for both radiofrequency and PFA, which have been clinically proven in preclinical studies to be crucial for lesion formation.

SmartPulse is a prospective, single-arm, multi-center clinical evaluation that will enroll approximately 250 patients with paroxysmal AF in the United States to assess the safety and effectiveness of the dual-energy STSF catheter.

The SmartPulse pivotal trial will allow us to learn more about the prospects of PFA in paroxysmal AFib. The dual-energy STSF catheter is an exciting innovation as it allows treatment customization by switching between radiofrequency and pulsed field energy. Natale stated that he conducted the first patient cases, and the ability to deliver two types of energy through a single catheter streamlined the workflow of ablation procedures. Additionally, its integration with the Carto 3 mapping system enables real-time catheter visualization, along with feedback on contact force measurement and ablation index—key factors for the creation of durable lesions.

In July 2023, Biosense Webster announced the completion of enrollment in the SmartfIRE study, which is evaluating the safety and effectiveness of the dual-energy STSF catheter in treating drug-refractory symptomatic paroxysmal AF in Europe.

The Thermocool Smarttouch SF catheter is the most commonly used ablation catheter worldwide. By integrating the advantages of RF and PFA into a single catheter familiar to EP practitioners, we enable physicians to control their preferred energy source while providing the point-by-point workflow many prefer. SmartPulse is the latest study in Biosense Webster's robust global clinical trial program for its investigational PFA portfolio, designed to ensure our differentiated platform equips EP with the real-time tools and information needed to deliver optimal patient care.

The technical opinions in this article do not represent the views of CCI.

Planning: Shen Li/Editor: Chen Baolin

Author: Yun Ye Xuan /Production: Wang Rui