THERMOCOOL SMARTTOUCH™ SF Catheter
The porous tip of the catheter paired with contact force technology is designed to optimize efficiency. The THERMOCOOL SMARTTOUCH™ SF Catheter provides uniform cooling at half the flow rate of earlier generation irrigated catheters, easing the fluid management process.
The catheter is seamlessly integrated with the CARTO™ 3 System, which combines contact force technology, 3-D mapping and advanced navigation capabilities to provide active measurement of stable contact force and catheter tip location.
About this device
The THERMOCOOL SMARTTOUCH™ SF Bi-Directional Navigation Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) energy to the catheter tip electrode for ablation purposes.
The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with a compatible RF generator and a dispersive pad (indifferent electrode). The catheter has force-sensing technology that provides a real-time measurement of contact force between the catheter tip and the heart wall.
Specialties
Electrophysiology (EP)
Procedures
Cardiac Catheter Ablation
Uniform cooling at half the flow rate
- Porous tip design enables maximum cooling efficiency regardless of catheter orientation or power delivered
- Designed to achieve the level and duration of power necessary to optimize lesion creation
Improves outcomes with more stable catheter-tissue contact force
- Allows active measurement of stable contact force and catheter tip direction
- Provides consistent movement in response to contact force using precision spring
- Sends accurate location reference signal via location sensor and transmitter coil
- Promotes consistent lesion formation
- Reduces ablation time6
- Improves outcomes with more stable catheter-tissue contact force2
Clinical evidence
88%
Up to 88% success rate1,2,i
In the multicenter SMART-AF clinical study, the THERMOCOOL SMARTTOUCH® Catheter demonstrated a 74% success rate and up to an 88% success rate, depending on the stability
within the contact force range2,3,*i
↓55%
Fluoroscopy5**
Reduction in total fluoroscopy time
↓19%
Procedure time4
Reduction in overall procedure time
↓52%
Fluid reduction4
Reduction in fluid delivered via catheter*
An integrated system
nGEN™ Generator
CARTO VIZIGO™ Bi-Directional Guiding Sheath
CARTO™ System Software
OCTARAY™ Mapping Catheter with TRUEref™ Technology
Related products
VARIPULSE™ Catheter
The VARIPULSE™ Platform’s full integration may reduce the need for multiple methods of catheter visualization used in one procedure, creating a streamlined workflow. Both clinical trial and real world evidence demonstrate the safety and value of VARIPULSE™ Platform.
QDOT MICRO™ Catheter
QDOT MICRO™ Catheter has been designed to provide temperature control through automatic adjustment of power and fluid output based on real-time temperature measurement. Use of higher average RF power with QDOT MICRO™ Catheter is enabled by this optimized temperature control.
THERMOCOOL™ Catheter
The catheter incorporates a thermocouple temperature sensor that is embedded in the 3.5 mm tip electrode. The high-torque shaft also allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.
References
- Natale A, Reddy V, Monir G, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014;64(7):647-656.
- THERMOCOOL SMARTTOUCH®, Bi-Directional Navigation Catheter M-5276-694E [Instructions for Use]. Irvine, CA: Biosense Webster, Inc.; 2014
- Prospective safety assessment of the ThermoCool SmartTouch™ SF family of contact force sensing catheters for the radiofrequency ablation treatment of drug refractory symptomatic PAF (SMART-SF). Data on file. Biosense Webster, Inc. Final Clinical Report, January 2016.
- Chinitz LA, Melby DP, Marchlinski FE, et al. Safety and efficiency of porous-tip contact-force catheter for drug-refractory symptomatic paroxysmal atrial fibrillation ablation: results from the SMART SF trial. Europace. 2018;20(FI_3):f392-f400. doi:10.1093/europace/eux264
- Osorio J., Maccioni S., Sharma R., et al. "QDOT MICRO™ versus THERMOCOOL® SMARTTOUCH™ and THERMOCOOL® SMARTTOUCH® Surround Flow in Radiofrequency Ablation of Paroxysmal Atrial Fibrillation". Journal of Comparative Effectiveness Research (2023).
- Martinek M, Lemes C, et al. Clinical impact of an open-irrigated radiofrequency catheter with direct force measurement on atrial fibrillation ablation. Pacing Clin Electrophysiol. 2013;35(11):1312-1318
i. Success defined as freedom from any atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) 12 months post-procedure when operator remained in the preset contact force range. Further subanalysis showed that when the contact force was within investigator-selected range ≥85% of time, success was increased by 21% to 88% (≥85%: n = 32; <85%: n = 73).
*When compared with the THERMOCOOL SMARTTOUCH™ Catheter.
**Ratio of Means: 0.45
95% CI: 0.38-0.54
When compared to ST/STSF. Retrospective study with a total of 435 patients
DO NOT use OCTARAY™ or OPTRELL™ Mapping Catheters with TRUEref™ Technology in patients with prosthetic valves.
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.
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
QDOT MICRO™ Catheters and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a compatible radiofrequency generator, for the treatment of:
- Type I atrial flutter in patients age 18 or older.
- Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.
QDOT MICRO™ Catheters provide real-time measurement of contact force between the catheter tip and heart wall, as well as location information when used with CARTO™ 3 Navigation System.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions. Caution: US law restricts this device to sale by or on the order of a physician.
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