smartfIRE

Footnotes:

*86.9% is based on a post hoc subgroup analysis treated with adherence to the recommended ablation workflow.

a. Freedom from recurrence was defined as freedom from documented symptomatic and asymptomatic atrial arrhythmia (AF/AFL/AT) episodes based on electrocardiographic data (≥30 seconds on arrhythmia monitoring device) during the effectiveness evaluation period (Day 91–365) on or off antiarrhythmic therapy. Acute procedural failure was also considered a failure for this endpoint.

b. Standard-of-care monitoring included 12-lead ECG and 24-hour Holter but did not include TTM.

c. In a post-hoc analysis, the high adherence group consisted of patients with more than 95% of applications maintaining an ITD of ≤6 mm and over 70% of applications achieving a minimum PF/RF index of 400 in the posterior wall and 500 in the anterior wall of the PV regions. Patients not meeting these criteria were categorized into the low adherence group.

d. Primary effectiveness endpoint was acute procedural success, defined as electrical isolation of targeted PVs (confirmed by final entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure. Use of a nonstudy device to achieve PV isolation was considered an acute procedural failure. The prespecified performance goal was 90%.

e. Primary adverse events included major vascular access complication or bleeding, myocardial infarction, pericarditis, pulmonary oedema, stroke or cerebrovascular accident, transient ischemic attack, thromboembolism, heart block, vagal nerve injury or gastroparesis, cardiac tamponade or perforation (up to 30 days post-procedure), and permanent phrenic nerve paralysis as well as PV stenosis, atrioesophageal fistula, and death (up to 90 days post-procedure). The protocol-defined performance goal was 12%. The safety evaluation was also conducted in a subset of patients (n=31) undergoing cardiac CT/MRA imaging for PV narrowing, neurological assessment for cerebral lesion including silent cerebral lesion, and esophageal endoscopy for esophageal thermal injury in a prospective manner. The primary adverse events reported in SmartfIRE were 2 PV stenosis, 2 cardiac tamponade/perforation, 1 stroke, and 1 pericarditis; all resolved without clinical sequelae. The primary adverse event adjudication based on specific energy type (RF or PF) was not an option and would have helped to further understand the relationship between adverse events and energy.

f. CTI ablation was included.

g. The PF ablations with all applications <100% status were excluded and considered as invalid; the time spent on energy delivery was counted as ablation time, excluding the intervals between each delivery.

h. At baseline, 27/134 (20.1%) patients had hospitalizations related to CV events, compared with 16/134 (11.9%) patients during the 12 months after ablation. The use of Class I/III AADs reduced to 23.9% (32/134), resulting in a relative reduction of 60.4% compared to baseline (P<0.001 with McNemar test).

Abbreviations:


AAD, antiarrhythmic drug; AF, atrial fibrillation; AFEQT, Atrial Fibrillation Effect on Quality-of-Life; AFL, atrial flutter; AT, atrial tachycardia; CI, confidence interval; CT, computed tomography; CTI, cavotricuspid isthmus; CV, cardiovascular; DE STSF, Dual Energy THERMOCOOL SMARTTOUCH™ SF; ECG, electrocardiogram; ITD, intertag distance; LA, left atrial; MRA, magnetic resonance angiogram; PAE, primary adverse event; PAF, paroxysmal atrial fibrillation; PF, pulsed field; PFA, pulsed field ablation; PV, pulmonary vein; PVI, pulmonary vein isolation; RF, radiofrequency; SOC, standard of care; TTM, transtelephonic monitoring.

Reference:

1. Duytschaever M, Račkauskas G, De Potter T, et al. Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results. Europace. 2024;26(5):euae088.
2. De Potter T, Scherr D, Pürerfellner H, et al. Dual energy for pulmonary vein isolation using focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 12-month results. Europace. 2025;27(9):euaf174.
   

Additional DE STSF Platform publications:

• Di Biase L, Marazzato J, Zou F, et al. Point-by-point pulsed field ablation using a multimodality generator and a contact force-sensing ablation catheter: Comparison with radiofrequency ablation in a remapped chronic swine heart. Circulation: Arrhythmia and electrophysiology. 2023;16(12):663–671.
• Nakagawa H, Farshchi S, Maffre J, et al. Evaluation of ablation parameters to predict irreversible lesion size during pulsed field ablation. Circulation: Arrhythmia and electrophysiology. 2024;17(8):e012814.  
• Verma A, Maffre J, Sharma T, et al. Effect of sequential,  co-localized radiofrequency and pulsed field ablation on cardiac lesion size and histology. Circulation: Arrhythmia and Electrophysiology. 2025; 18(2):e013143.
• Kawamura I, Bhardwaj R, Govari A, et al. Coronary involvement with pulsed field ablation and radiofrequency ablation: preclinical insights. Circulation: Arrhythmia and Electrophysiology. 2025;18(1):e013161.

Disclosures:


The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter and TRUPULSE™ Generator with Connection Interface Unit have received CE mark for use in the European Union but are currently investigational in the United States and have not been approved by the FDA. 
Important information: Prior to use, refer to the instructions for use supplied with the device for indications, contraindications, side effects, warnings and precautions.

Always verify catheter tip location using common clinical practice for real-time verification (inspection of IC signals, direct imaging guidance such as fluoroscopy or ultrasound, etc.) and consult the CARTO™ 3 System User Guide regarding recommendations for fluoroscopy use.
 


Canpolat, U. et al (2020). State of Fluoroless Procedures in Cardiac Electrophysiology Practice. J Innov Cardiac Rhythm Management. 11(3), 4018–4029.
 Sommer, P. et al (2018) Safety profile of near-zero fluoroscopy atrial fibrillation ablation with non-fluoroscopic catheter visualization: experience from 1000 consecutive procedures, EP Europace, Volume 20, Issue 12, Pages 1952–1958.

The THERMOCOOL SMARTTOUCH™ SF Catheter is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (AF) and for drug refractory recurrent symptomatic persistent AF (continuous AF > 7 days but < 1 year), refractory or intolerant to at least 1 Class I or III AAD, when used with the CARTO™ 3 System.

DO NOT use OCTARAY™ Mapping Catheter with TRUEref™ Technology in patients with prosthetic valves.

DO NOT use PENTARAY™ NAV ECO High Density Mapping Catheter or OCTARAY™ Mapping Catheter with TRUEref™ Technology in patients with prosthetic valves

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