This blocks the electrical path that causes the abnormal heart rhythm. For general information, Learn About Clinical Studies. COVID-19 is an emerging, rapidly evolving situation. The catheter is removed after treatment. Two types of ThermoCool SmartTouch catheter are available, with either a uni‑directional tip (available with deflectable distal curves of 73.5 mm, 84.5 mm or 98.5 mm) or a bi‑directional tip (available with symmetrical deflectable distal curves of 73.5 mm, 84.5 mm or 98.5 mm and asymmetrical deflectable distal curves of 73.5 mm/84.5 mm or 84.5 mm/98.5 mm). Sign in to add this product to your favorites! Additional components needed for the ablation procedure include: The CARTO 3 navigation system, with SmartTouch 3D software module and integrated display screen, designed to visualise the real‑time calculated position and orientation of the catheter within the patient's heart. One specialist commentator noted that the consistent message from general published evidence is that contact force‑guided ablation results in better isolation of the pulmonary veins, and improvement in clinical outcomes in addition to other surrogates such as procedure time and radiation dose, when compared with non‑contact force‑guided ablation. One specialist commentator stated that contact force is 1 of several variables that affect ablation delivery. Biosense Webster offers a number of service contracts for hardware covering 1, 2 or 3 years, which cost: CARTO 3 navigation system: £12,000, £23,000, £32,000. Using either the CARTO or NavX system, the 3-D shell representing the LA and PVs is constructed using the ablation or ring catheter, or both. Load Time 0.06 seconds • System time 2020-10-14 19:11:09. ThermoCool SmartTouch would be used in people diagnosed with symptomatic atrial fibrillation when drug treatment has failed to control their symptoms (NICE guidance on the management of atrial fibrillation). The manufacturer states that the patient having had a ventriculotomy or atriotomy within the preceding 4 weeks and the presence of a prosthetic valve are contraindications for using ThermoCool SmartTouch. Biosense Webster, Inc. is a global leader in the science of diagnosing and treating heart rhythm disorders. Listing a study does not mean it has been evaluated by the U.S. Federal Government. PVI catheter ablation is typically done under fluoroscopy guidance and therefore not recommended in people who are pregnant. One specialist commentator noted that real‑time dynamic contact force feedback during cardiac ablation procedures would enable operators to adjust catheter position, improve procedure efficacy and increase safety by avoiding the application of excessive force. Biosense Webster does not specify a target contact force or a force range for an ablation procedure. Caution: US Federal law restricts this device to … It would replace conventional radiofrequency ablation catheters without contact force‑sensing technology, which are typically used with a separate mapping catheter. The guidance further recommends that the procedure should only be done in specialist units and with arrangements for cardiac surgical support in the event of complications, and should only be done by cardiologists with extensive experience of other types of ablation procedures. NICE has produced a medtech innovation briefing on the TactiCath Quartz catheter. ThermoCool SmartTouch and its additional components are indicated for catheter‑based cardiac ablation when used with a compatible radiofrequency generator, and also for cardiac electrophysiological mapping. The catheters comprise several parts: A deflectable distal section containing several electrodes, including a 3.5 mm tip electrode. Observe and characterize the changes in relative conductivity between the six ACL patches over period of six hours. This allows a representation of part of catheter to be seen within the mapping system and contributes to the reduced need for fluoroscopy during catheter manipulation. Page 1. Fluoroscopy and electrocardiograms are used to aid catheter positioning. PLEASE READ THIS DOCUMENT CAREFULLY BEFORE USING THE CARTO® 3 SYSTEM. Six disposable dispersive pads and an earthing pad which complete the ablation circuit. ThermoCool SmartTouch can only be used with Biosense Webster radiofrequency generators, such as the SMARTABLATE system with integrated irrigation pump (£35,000) or the Stockert EP Shuttle radiofrequency generator used with the separate COOLFLOW irrigation pump (£14,999 and £8,999 respectively). All of the electrodes may be used for stimulating and recording (required for electrophysiological mapping) so a separate cardiac mapping catheter is not needed when using ThermoCool SmartTouch for ablation. ** In accordance with catheter indication for use. These costs can be reduced for customised NHS contracts depending on volume and contract duration, and local arrangements . Contraindications for use are similar to other cardiac ablation catheters, and include: cardiac surgery within previous 8 weeks; artificial heart valves; active systemic infection; use in coronary vasculature; myxoma (a heart tumour) or intracardiac thrombus (blot clot); trans‑septal atrial approach in patients with an interatrial baffle or patch; retrograde trans‑aortic approach in patients with aortic valve replacement; and use with an introducer sheath of less than 8.5 Fr. References * The open-platform feature of the EnSite Precision™ cardiac mapping system allows for use of almost any catheter for mapping, thus offering superior flexibility as compared to the CARTO ‡ system by Biosense Webster, which limits use to Biosense Webster catheters only. This requires the integration of other variables than contact force into ablation delivery. a git repository would be checked if the GIT_TAG does not refer to a specific commit). Tissue thicknesses differ between different areas of the atrium and the atrium is surrounded by structures such as the oesophagus posteriorly which may be particularly sensitive to heating. Study record managers: refer to the Data Element Definitions if submitting registration or results information. A reduction in fluoroscopy time was highlighted as being important by another specialist commentator given the hazards associated with ionising radiation to both patients and operators.
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