Three-month follow-up results from the SmartfIRE clinical trial, investigating Biosense Webster’s Thermocool Smarttouch SF dual energy catheter were presented in a late-breaking trial session at the European Heart Rhythm Association (EHRA) congress (7–9 April, Berlin, Germany).
Tom De Potter, an investigator in the study, reported that the findings showed that the use of the catheter during standard electrophysiology mapping and ablation procedures in drug refractory symptomatic paroxysmal AFib patients led to a 100% acute procedural success, with 96.8% no acute reconnections shown in the veins.
The Dual Energy Thermocool Smarttouch SF catheter is a dual energy pulsed field ablation (PFA)/radiofrequency (RF) ablation catheter integrated with a PF and RF ablation index.
The ablation system evaluated in the SmartfIRE study consists of the dual energy Thermocool Smarttouch SF catheter—an irrigated, contact-force sensing catheter—and the Trupulse generator, providing both RF and PF energy to the catheter through the toggling of the two energy sources on the generator monitor.
The catheter and the generator are fully integrated with the world’s leading Carto3 system, enabling live 3D mapping and advanced visualisation during ablation procedures.
“Early results from the SmartfIRE study show that the use of the dual energy Thermocool Smarttouch SF ablation system led to complete three-month acute procedural success in patients with paroxysmal atrial fibrillation, while demonstrating the seamless transition of ablation workflow to a dual energy platform,” said Mattias Duytschaever (Sint-Jan Hospital, Brugge, Belgium), an investigator in the study. “Having the ability to easily switch between RF and PF energy provides the flexibility to customise treatment depending on the patient anatomy and clinical need, enabling electrophysiologists to perform more targeted ablation procedures which could lead to improved outcomes for patients.”
SmartfIRE is a prospective, multicentre, single-arm study evaluating the safety and efficacy of the Dual Energy Thermocool Smarttouch SF catheter with the Trupulse generator, in the treatment of patients with recurrent paroxysmal AF in Europe.
When used for isolation of the atrial pulmonary veins (PVs) in the treatment of patients with paroxysmal AF (n=137), catheter ablation using PF and RF enabled a total energy application time of median 12.8 minutes and fluoroscopy exposure of 4.2 minutes.
Primary adverse events in the SmartfIRE study were seen in 4.4% of patients (n=137). Prespecified remapping performed at 75 (+/-15) days post-procedure in subset of patients showed 87% of targeted veins as durable isolated.
