The TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) study was a prospective, randomized, controlled, multicenter study conducted to evaluate the safety and effectiveness of the CF catheter (TactiCath, St. Jude Medical, St. Paul, MN) for the treatment of symptomatic paroxysmal AF. The study, conducted under an Investigational Device Exemption for regulatory approval, was designed as a noninferiority trial for safety and effectiveness. It was not powered for superiority. Subjects were enrolled at 17 clinical sites and treated by 47 operators in Europe and the United States. The Ethics Committee or Institutional Review Board of each participating institution approved the study protocol, and written informed consent was obtained from all patients. An independent Data Safety Monitoring Board supervised the study.
Tacticath
Manufactured by Abbott
Sourced in United States
TactiCath is a medical device designed for use in cardiac ablation procedures. It is an electrophysiology catheter that provides real-time tissue contact force measurement to assist physicians during the procedure.
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Lab products found in correlation
Thermocool smarttouch, by Johnson & Johnson (8 mentions)
Navistar thermocool, by Johnson & Johnson (3 mentions)
Pentaray, by Johnson & Johnson (3 mentions)
Coolflex, by Abbott (2 mentions)
Flexability, by Abbott (2 mentions)
Thermocool, by Johnson & Johnson (2 mentions)
Carto 3, by Johnson & Johnson (2 mentions)
Arctic front advance, by Medtronic (2 mentions)
Smarttouch, by Johnson & Johnson (2 mentions)
Ensite velocity system, by Abbott (2 mentions)
Thermocool sf, by Johnson & Johnson (1 mentions)
Celsius, by Johnson & Johnson (1 mentions)
Inquiry optima, by Abbott (1 mentions)
Blazer, by Boston Scientific (1 mentions)
Ensite velocity, by Abbott (1 mentions)
Rhythmia mapping system, by Boston Scientific (1 mentions)
Brockenbrough needle, by Abbott (1 mentions)
Carto 3 system, by Johnson & Johnson (1 mentions)
Intellamap orion, by Boston Scientific (1 mentions)
Sapphire blue, by Abbott (1 mentions)
21 protocols using tacticath
1
TactiCath Contact Force Ablation for AF
2
Comprehensive Atrial Fibrillation Ablation Protocol
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We performed electroanatomical mapping using a three-dimensional (3D) electroanatomical mapping system (NavX; Abbott Inc, Minnetonka, Minnesota, USA, or CARTO; Biosense Webster Inc, Diamond Bar, California, USA) merged with 3D spiral CT. To conduct circumferential PVI, we used an open-irrigated tip catheter (Celsius, Johnson & Johnson; Navistar ThermoCool, Biosense Webster; ThermoCool SF, Biosense Webster; ThermoCool SmartTouch, Biosense Webster; Coolflex, St. Jude Medical; FlexAbility, St. Jude Medical; and TactiCath, St. Jude Medical). After circumferential PVI, we confirmed electrical PVI and bidirectional block. Additional linear ablation, such as posteroinferior line, roof line, anterior line, left lateral isthmus line, right atrial ablation and/or complex fractionated electrograms, was performed at the operator’s discretion. After completion of the circumferential PVI or extra-PV ablation, isoproterenol infusion (5–10 µg/min) was administered to map the extra-PV triggers. If mappable AF triggers or frequent premature atrial complex (PAC) were present, we carefully mapped and ablated the non-PV triggers.
3
Radiofrequency Catheter Ablation for Atrial Fibrillation
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All procedures were performed under general anesthesia. Transoesophageal echocardiography was performed preprocedurally to exclude the presence of left atrial thrombus. Vascular access was via the right and/or left femoral veins using two transseptal long sheaths (SL0, St. Jude Medical Inc., St Paul, MN, USA). Transseptal access was performed using a Brockenbrough needle (St. Jude Medical Inc.). After gaining LA access, unfractionated heparin was given to achieve an activated clotting time of greater than 300 seconds.
Mapping and ablation were performed using an electro‐anatomic mapping system (CARTO‐3 system, Biosense Webster, Diamond Bar, CA, USA; EnSite Velocity, St. Jude Medical, St Paul, MN, USA; Rhythmia mapping system, Boston Scientific, Marlborough, MA, USA). Multipolar mapping catheters were used in all cases (Lasso or PentaRay, Biosense Webster; Inquiry Optima, St. Jude Medical; IntellaMap Orion, Boston).
Ablation was performed with 3‐4 millimetre irrigated‐tip catheters (Thermocool SmartTouch or Thermocool, Biosense Webster; TactiCath or Flexability, St. Jude Medical; Blazer, Boston Scientific). Power settings of 25‐30 watts (w) were used in all areas other than for a cavotricuspid isthmus (CTI) line, where up to 40 w was used, and for a mitral isthmus line, where up to 35 w was used. No specific guidance concerning contact force settings was given.
Mapping and ablation were performed using an electro‐anatomic mapping system (CARTO‐3 system, Biosense Webster, Diamond Bar, CA, USA; EnSite Velocity, St. Jude Medical, St Paul, MN, USA; Rhythmia mapping system, Boston Scientific, Marlborough, MA, USA). Multipolar mapping catheters were used in all cases (Lasso or PentaRay, Biosense Webster; Inquiry Optima, St. Jude Medical; IntellaMap Orion, Boston).
Ablation was performed with 3‐4 millimetre irrigated‐tip catheters (Thermocool SmartTouch or Thermocool, Biosense Webster; TactiCath or Flexability, St. Jude Medical; Blazer, Boston Scientific). Power settings of 25‐30 watts (w) were used in all areas other than for a cavotricuspid isthmus (CTI) line, where up to 40 w was used, and for a mitral isthmus line, where up to 35 w was used. No specific guidance concerning contact force settings was given.
4
Irrigated RF Ablation Lesions
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With a 7-Fr irrigated ablation catheter (TactiCath, St. Jude Medical, Minnetonka, MN, USA), 40 W, 30, and 60 s point-by-point RF ablation lesions using a cardiac ablation generator (IBI-1500T7, Irvine Biomedical, CA, USA) were created at random positions at the LA wall. Care was taken to achieve stable catheter contact. The experimental setup did not allow to measure contact force even though a contact force catheter was used. Heparinized saline catheter irrigation was set at 30 mL/min during ablation, maximum tip temperature was set at 42°C. Number of bubbles, bubble size, and total gas volume per application were measured and stored.
5
Circumferential Pulmonary Vein Isolation
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Circumferential PVI was performed in all 29 patients point by point using irrigated catheters (Cool-Flex/TactiCath/Sapphire-Blue, St. Jude Medical). Energies ranging 25–35 W were delivered via conventional ablation in both pairs of pulmonary veins. Additionally, FIRMap 64-poles mapping catheters were consecutively placed in the right and left atrium for 3-dimensional electroanatomic imaging (NavX, St. Jude Medical). Cather placement was achieved via vein access through the femoral vein reaching the right atrium and later to the left atrium through transeptal punction. In patients arriving in sinus rhythm electrical burst pacing was used to induce AF (Rodrigo et al., 2020 (link)).
6
Radiofrequency Ablation Technique for Atrial Fibrillation
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For the MAN group, ablation was done by standard technique utilizing open irrigated ablation and mapping catheters (3.5 mm Navistar thermocool, Biosense-Webster Inc./Flexibility, St. Jude Medical Inc./Tacticath, St. Jude Medical Inc.) and multipolar deflectable catheters (Lasso, Biosense-Webster Inc. or Inquiry Optima Plus, St. Jude Medical Inc.). The two 3D electroanatomic mapping system used were the Carto3 (Biosense-Webster Inc.) as described above or the Ensite NavX system (St. Jude Medical Inc.). Briefly, the Ensite NavX system uses impedance measurements between individual catheter electrodes and external patches placed on the chest to project a 3D image of the catheters. Temperature control settings were similar to the remote magnetic navigation group.
7
Cryoballoon, PVAC, and RF Ablation Protocols
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Every patient signed written informed consent prior to the ablation procedure. Transesophageal echocardiography was performed immediately prior to the procedure in all patients. PVI was done with the cryoballon (second‐generation cryoballoon [ArcticFront Advance, Medtronic, Minneapoiis]; n = 79), the multielectrode phased‐radiofrequency ablation catheter (PVAC Gold catheter [Medtronic, Minneapolis, USA], n = 41)5 or a radiofrequency point‐by‐point ablation (n = 26)6 under sedation with midazolam and/or propofol. Surface electrocardiograms and endocardial electrograms were continuously monitored and stored on a computer‐based recording system. Patients of cryoballoon and the PVAC group were treated with one transseptal sheath. Patients of the radiofrequency (RF)‐group were ablated employing two transseptal sheaths for a decapolar LASSO‐catheter and a 3.5 mm irrigated tip catheter (Tacticath, St. Jude Medical, Saint Paul, Minnesota) and a 3D mapping system (NavX, St. Jude Medical).7 In all groups, the catheter setup was complemented by a decapolar coronary sinus catheter and a quadripolar catheter that was positioned in the right ventricle. After ablation, protone pump‐inhibitors were added to the medication of every patient for 4 weeks after ablation to prevent esophageal damage associated to ablation.8 , 9 , 10
8
Contact Force Sensing Catheter for Atrial Flutter Ablation
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A novel CF-sensing catheter were used as described previously (TactiCath; St. Jude Medical). 9, 10 Briefly, it is an open-irrigation catheter that contains a triaxial sensor located between the second and third electrodes, which measures the force (amplitude and direction) of the contact between the tissue and the catheter-tip electrode. The CF sensor has a resolution and sensitivity of 1 gram (g) in a bench test. 9 Each RF lesion was logged for average CF (in g) and force-time integral (FTI = real-time force x ablation time, g*s). 9 The average CF, FTI, lesion location on the CTI and the duration of RF were recorded. The CTI was divided into equal length segments (annular, mid, and caval) for the purpose of region-specific analysis of CF. 11 RF time required to achieve bidirectional block for the first time during the procedure, the site of the last lesion that resulted in bidirectional block, and site of acute conduction recurrence were recorded.
9
Catheter Ablation of Atrial Flutter
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Induction of AFL was done through rapid pacing with and without isoproterenol as needed. A surface electrocardiogram with a visible AFL wave was added to the mapping window to confirm stability of the reference electrogram relative to the AFL wave. The timing reference for the window was set at 60 ms before the onset of the most prominent flutter wave on the surface electrocardiogram, and the window spanned 95% of the tachycardia cycle length. Isochronal maps were created and were displayed as 8 equal time intervals, with the AFL circuit delineated by tracing the leading edge of each color.
CI sites were identified as areas with significant conduction slowing, similarly defined by isochronal crowding (>3 isochrones within a 1 cm radius), and where ablation terminated the arrhythmia. Ablation was performed during AFL targeting the narrowest portion of the region exhibiting maximal conduction slowing (isochronal crowding), confirmed to have long-duration fractionated signals. Ablation was performed using an open irrigated ablation catheter (Tacticath; Abbott Laboratories or IntellaNav; Boston Scientific) at 35–50 watts. The procedural endpoint was noninducibility of AFL. All patients also underwent pulmonary vein isolation (PVI) if pulmonary vein conduction was present.7 (link)
CI sites were identified as areas with significant conduction slowing, similarly defined by isochronal crowding (>3 isochrones within a 1 cm radius), and where ablation terminated the arrhythmia. Ablation was performed during AFL targeting the narrowest portion of the region exhibiting maximal conduction slowing (isochronal crowding), confirmed to have long-duration fractionated signals. Ablation was performed using an open irrigated ablation catheter (Tacticath; Abbott Laboratories or IntellaNav; Boston Scientific) at 35–50 watts. The procedural endpoint was noninducibility of AFL. All patients also underwent pulmonary vein isolation (PVI) if pulmonary vein conduction was present.7 (link)
10
PV Mapping and Ablation Procedure Protocol
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All patients underwent an electrophysiological study in the fasting state under conscious sedation. A 20‐pole catheter was inserted through the right jugular vein (BeeAT® Japan Lifeline). The proximal portion of the catheter was positioned along the superior vena cava and crista terminalis, and the distal portion was positioned in the coronary sinus (CS) for pacing and internal cardioversion.
Following a trans‐septal puncture under guidance with an intracardiac echocardiography catheter (5.5–10 MHz, 8Fr, AcuNav™, Biosense Webster), two or three long sheaths (SL1®, AF Division, St. Jude Medical) were introduced into the LA via the same trans‐septal puncture site. After a left atriography was performed, 20‐pole circular mapping catheters (1–5–1 mm interelectrode spacing, 20 mm in diameter, and/or 1–3.5–1 mm interelectrode spacing, 15 mm in diameter) and a 3.5 mm open‐irrigated‐tip ablation catheter (Navistar® Thermocool®, Biosense Webster or Thermocool Smarttouch®, Biosense Webster, or TactiCath™, Abbott) were positioned in the PVs for PV mapping (Figure1A ). In four patients, PV mapping was also performed with a 64‐pole basket catheter (Constellation®, Boston Scientific) (Figure 1B ). The electrophysiological studies were performed under support of an electroanatomical mapping system with the CARTO® system (Biosense Webster) or Ensite Velocity™ system (St. Jude Medical).
Following a trans‐septal puncture under guidance with an intracardiac echocardiography catheter (5.5–10 MHz, 8Fr, AcuNav™, Biosense Webster), two or three long sheaths (SL1®, AF Division, St. Jude Medical) were introduced into the LA via the same trans‐septal puncture site. After a left atriography was performed, 20‐pole circular mapping catheters (1–5–1 mm interelectrode spacing, 20 mm in diameter, and/or 1–3.5–1 mm interelectrode spacing, 15 mm in diameter) and a 3.5 mm open‐irrigated‐tip ablation catheter (Navistar® Thermocool®, Biosense Webster or Thermocool Smarttouch®, Biosense Webster, or TactiCath™, Abbott) were positioned in the PVs for PV mapping (Figure
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