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ACCURACY MATTERS - SEE THINGS DIFFERENTLY

The TactiCath™ Quartz ablation catheter enhances the ablation procedure by providing you with easy-to-understand measurements of the contact force (CF) applied between the catheter tip and the tissue surface.

OVERVIEW
EVIDENCE
TECHNOLOGY
SPECIFICATIONS

ONLY ONE HAS 6X GREATER ACCURACY IN CONTACT FORCE SENSING*1,2

The TactiCath™ Quartz ablation catheter has proven greater accuracy in contact force sensing than ThermoCool SmartTouch‡ SF catheter.*1,2

graphic showing the mean absolute difference of force versus maximum force error

 

VIEW ELECTROPHYSIOLOGY PRODUCT CATALOG
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TACTICATH™ QUARTZ ABLATION CATHETER FEATURES AND REQUIREMENT

The main features of this unique ablation catheter include:

  • Force sensor at the distal catheter tip
  • Fiber optic technology for optimal stability during contact force measurement
  • 65 or 75 mm deflectable curve
  • Requires TactiSys™ Quartz hardware system and accessories
  • Compatibility with steerable sheaths (such as the Agilis™ NxT introducer), resulting in increased contact force6
UNIQUE ADVANTAGES OF THE TACTICATH™ QUARTZ ABLATION CATHETER AND THE TACTISYS™ QUARTZ SYSTEM

Designed for seamless integration, the TactiSys Quartz system is a plug-and-play system—eliminating the need for thermal calibrations. It also offers: 

  • High-precision contact force measurements with 1 g resolution
  • Real-time feedback: fast 50 Hz (20 ms) sample rate
  • 2-5-2 electrode spacing for standard electrogram recordings
  • Minimal influence of temperature for stable contact force measurement
  • No impact on the force measurement accuracy from nearby ferrous materials (braiding of sheath, nearby circular mapping catheters)
  • The FTI™ index, a proprietary index calculating force over time, has been clinically validated and is incorporated into the TactiCath Quartz contact force sensing ablation catheter labeling3-5
  • The LSI (Lesion Index) is a proprietary index combining contact force, radiofrequency (RF) application duration and RF current**
  • Full integration with the EnSite™ Precision™ cardiac mapping system   via the EnSite™ contact force module
COMPREHENSIVE CARDIAC ABLATION THERAPY AND ARRHYTHMIA MANAGEMENT

The TactiCath Quartz ablation catheter is one of our featured electrophysiology products. We are leading the way with inventive designs that give you the options you need to diagnose, treat and manage arrhythmias with versatility  and effectiveness. When it comes to understanding and managing cardiac arrhythmias, we are your partner for life.

Read more about our approach to electrophysiology.

RESOURCES AND DOCUMENTATION

Product Manual (Instructions for Use)

Tacticath™ Quartz Ablation Catheter Clinical Compendium

REFERENCES

*In an independent head-to-head bench test comparison with the ThermoCool SmartTouch SF catheter, TactiCath Quartz contact force ablation catheter showed higher accuracy in both axial (perpendicular) and parallel (lateral) orientations.1
**This parameter was displayed during ablation procedures in a 31-patient supplemental study to the TOCCASTAR clinical trial. However, the clinical utility of this parameter has not been evaluated. 

1. Bourier F, Deisenofer I, Hessling G, et al. (2016, May). Contact force sensing electrophysiological catheters: How accurate is the technology? [Abstract PO03-170]. Presented at HRS 2016, San Francisco, CA. Heart Rhythm. 2016;13(5 Suppl 1):S318-S319.
2. Bourier F, Gianni C, Dare M, et al. Fiberoptic Contact-Force Sensing Electrophysiological Catheters: How Precise Is the Technology? J Cardiovasc Electrophysiol. 2017 Jan;28(1):109-114.
3. Reddy, V., Shah, D., Kautzner, J., Schmidt, B., Saoudi, N., Herrera, C., … Kuck, K. H. (2012). The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm, 9(11), 1789-1795. http://dx.doi.org/10.1016/j.hrthm.2012.07.016 
4. Neuzil, P., Reddy, V., Kautzner, J., Petru, J. Wichterle, D., Shah, D., … Kuck, K. H. (2013). Electrical reconnection after pulmonary vein isolation is contingent on contact force during initial treatment: Results from the EFFICAS I Study. Circulation: Arrhythmia and Electrophysiology, 6(2), 327-333. http://dx.doi.org/10.1161/CIRCEP.113.000374 
5. Kautzner, J., Neuzil, P., Lambert, H., Peichl, P., Petru, J., Cihak, R., ... Kuck, K. H. (2015). EFFICAS II: Optimization of catheter contact force improves outcome of pulmonary vein isolation for paroxysmal atrial fibrillation. Europace, 17(8), 1229-1235. http://dx.doi.org/10.1093/europace/euv057
6. Mansour, M. (2014, May). TOCCASTAR: Preliminary results of the first prospective randomized study of a contact force sensing ablation catheter for the treatment of paroxysmal AF. Presented at the meeting of the Heart Rhythm Society, San Francisco, CA.

COMPREHENSIVE SUPPORTING EVIDENCE

At Abbott, our goal is to advance the treatment of cardiac arrhythmias with innovations that improve both cost savings and clinical outcomes.

 

HIGHER ACCURACY6, 10,*

In an independent head-to-head bench test comparison with the ThermoCool SmartTouch SF catheter, TactiCath Quartz contact force ablation catheter showed higher accuracy in both axial (perpendicular) and parallel (lateral) orientations.10

  • ThermoCool SmartTouch‡ SF catheter: 6.0 g mean absolute difference; 30 g maximum error
  • TactiCath Quartz catheter: ≤ 1.2 g mean absolute difference; 5 g maximum error
graphic showing the reference force relationship to the contact force catheter measurement
OPTIMIZED PATIENT OUTCOMES1-4

Data from studies such as TOCCATA, EFFICAS I and EFFICAS II show that contact force (CF) sensing is not only safe for use in pulmonary vein isolation (PVI) but also associated with lower rates of PV reconnection and atrial fibrillation (AF) recurrence.1-4 As the cost of care has been reported to increase approximately four times in the first year after ablation for patients with repeat ablations, increased effectiveness of single ablation procedures for AF could substantially decrease health care costs for patients undergoing these procedures.8, 9

Tacticath™ Quartz Ablation Catheter Study Highlights

graphic showing study highlights

 

Contact Force Recommendations3,4
graphic showing target goals

 

Toccastar Effectiveness: Optimal Contact Forcea Clinical Studies5

 

graphic showing optimal versus non-optimal success at twelve months

 

VIEW ELECTROPHYSIOLOGY PRODUCT CATALOG
View Product Catalog
  • TOCCATA CLINICAL TRIAL

    The purpose of the TOCCATA clinical trial was to evaluate the safety and efficacy of CF sensing during ablation procedures.1, 2

    Key Takeaways:
    • Real-time CF sensing is safe for use in RF ablation of SVT and AF.1
    • There is little correlation between tactile feel and real contact force applied, resulting in high variability of forces applied between users when CF information is not available.
    • High CFs may occur during catheter manipulation and not just during ablation, suggesting that measuring CF may provide additional useful information to the operator for safe catheter manipulation.
    • TOCCATA was the first multicenter trial that used a direct CF catheter in human subjects.
    • The TOCCATA study results were the first to show that CF > 20 g is most likely to result in durable PVI at 12 months, while CF < 10 g is associated with unsuccessful PVI.2
    • Using the TactiCath ablation catheter to measure CF helps ensure successful PVI regardless of anatomical location.2
    • At least 10 g of force is needed to provide sufficiently stable catheter tip contact. Intermittent contact is correlated with low CF (p < 0.001).2
    • TOCCATA validated the safety and feasibility of force-sensing, while confirming the importance of contact force (CF) technology.1, 2
    Recurrence Rates By Average Ablation Contact Force2

    graphic showing a twelve-month, long-term clinical outcome

  • EFFICAS I AND II CLINICAL STUDIES

    EFFICAS is a pair of studies to (I) identify and (II) validate CF recommendations to ensure pulmonary vein isolation.

    Key Takeaways:
    • Minimum CF and minimum FTI™ values are strong predictors of PVI gap likelihood.4
    • Durable PV isolation appears to be further improved when ablation lesions are created point-by-point continuously around the PV using a low Continuity Index™ (CI).5
    • The EFFICAS I trial provided the CF recommendations of a target CF of 20 g, minimum CF ≥ 10 g, minimum FTI of 400 gs, targeting transmurality in a single RF application.4
    • EFFICAS II provided clinical validation that following recommendations to optimize catheter contact force (target CF = 20 g, minimum CF ≥ 10 g, minimum FTI ≥ 400 gs) and creating a contiguous lesion in a single RF application (low CI < 6) can achieve successful PV isolation.5
    • Optimal contact force with the TactiCath ablation catheter and contiguous lesion deployment reduces occurrence of PV gaps at 3 months.5

    Read more about the EFFICAS II study.

    Efficas I and II Clinical Study Summary3,4

     

     

    graphic showing steps to identify and validate recommendations

    Efficas I: PVI Success Rates By Minimum FTI3

    raphic showing steps to identify and validate recommendations

    Efficas II: Continuity Index4

    graphic showing adjacent versus non-adjacent lesions

    Efficas I and Efficas II Clinical Comparison4,5

    graphic showing variant ablations

  • TOCCASTAR CLINICAL TRIAL5

    The TOCCASTAR trial (TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation) is the only prospective, randomized, controlled, multicenter study conducted to date to evaluate the safety and effectiveness of a contact force sensing ablation catheter for the treatment of symptomatic paroxysmal AF.5

    Key Takeaways:

    • The TOCCASTAR trial successfully met its primary safety and efficacy endpoints demonstrating the safety and effectiveness of the TactiCath™ Contact Force ablation catheter for the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation.
    • TactiCath ablation catheter safety results were excellent with 0.7% tamponade.5 (Previous SMART-AF results reported tamponade at 2.5%.7)
    • Physicians who used Optimal CF achieved 12-month clinical success in 85.5% of patients versus 67.7% when Non-optimal CFc was used.a,b,c
      • This is consistent with findings from the TOCCATA and EFFICAS studies that fewer lesions at CF < 10 g correlates with increased treatment success.1-4
    • Optimal CF procedures were associated with similar or lower RF power than non-optimal CF procedures.5
    • Optimal CF group had a 7.2% rate of repeat ablation as compared to 12.7% for the control group and 16.1% for the non-optimal CF group at 12 months.5
    Contact Force and Control: Rate of Repeat Ablation5
     

    graphic showing optimal versus non-optimal CF compared to a control group

Read comprehensive information on these clinical studies:

TactiCath™ Quartz Ablation Catheter Clinical Compendium

ECONOMIC IMPACT OF AF ABLATION FIRST-PROCEDURE SUCCESS USING THE TACTICATH™ QUARTZ CATHETER8, 9

A recent publication by Moussa Mansour et al. demonstrates that for patients undergoing repeat ablations, the cost of care increases approximately four times—to $52,821—in the first year after ablation and remained forty-six percent higher, even when excluding the cost associated with the additional ablation procedures.9

“COST OF CARE REMAINED 46% HIGHER FOR REPEAT ABLATIONS, EVEN EXCLUDING THE COST ASSOCIATED WITH THE ADDITIONAL PROCEDURES.” 9
Key Findings

Another analysis showed that the use of optimal contact force guided AF ablationa with the TactiCath™ Quartz catheter resulted in fewer post ablation clinical events, translating to a 15-percent reduction in post ablation management costs ($3,402 savings per patient) in the year after ablation, compared with patients who were treated with a non-contact force ablation catheter.8

Read the article.

© 2016 by the American College of Cardiology Foundation. Published by Elsevier.

COMPREHENSIVE CARDIAC ABLATION THERAPY AND ARRHYTHMIA MANAGEMENT

The TactiCath Quartz ablation catheter is one of our featured electrophysiology products. As a leader in ablation and mapping technology, our vision is to transform the treatment of cardiac arrhythmias by designing outcome-driven and cost-effective technologies. Read more about our approach to electrophysiology.

RESOURCES AND DOCUMENTATION

Product Manual (Instructions for Use)

Tacticath™ Quartz Ablation Catheter Clinical Compendium

REFERENCES

‡Indicates a third party trademark, which is property of its respective owner.

a. Optimal CF contact defined as those patients where ≥ 90% lesions ≥ 10 g. 
b. Nonoptimal CF contact defined as those patients where ˂ 90% lesions ≥ 10 g. 
c. Clinically relevant success: no documented, symptomatic recurrence of atrial arrhythmia > 30 seconds (patient could use an AAD). 
*In an independent head-to-head bench test comparison with the ThermoCool SmartTouch SF catheter, TactiCath Quartz contact force ablation catheter showed higher accuracy in both axial (perpendicular) and parallel (lateral) orientations.10

1. Kuck K. H., Reddy, V.Y., Schmidt, B., Natale, A., Neuzil, P. Saoudi, N., … Shah, D. C. (2012). A novel radiofrequency ablation catheter using contact force sensing: Toccata study. Heart Rhythm, 9(1), 18-23. http://dx.doi.org/10.1016/j.hrthm.2011.08.021 
2. Reddy, V., Shah, D., Kautzner, J., Schmidt, B., Saoudi, N., Herrera, C., … Kuck, K. H. (2012). The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm, 9 (11), 1789-1795. http://dx.doi.org/10.1016/j.hrthm.2012.07.016 
3. Neuzil, P., Reddy, V., Kautzner, J., Petru, J. Wichterle, D., Shah, D., … Kuck, K. H. (2013). Electrical reconnection after pulmonary vein isolation is contingent on contact force during initial treatment: Results from the EFFICAS I Study. Circulation: Arrhythmia and Electrophysiology, 6 (2), 327-333. http://dx.doi.org/10.1161/CIRCEP.113.000374 
4. Kautzner, J., Neuzil, P., Lambert, H., Peichl, P., Petru, J., Cihak, R., … Kuck, K. (2015). EFFICAS II: optimization of catheter contact force improves outcome of pulmonary vein isolation for paroxysmal atrial fibrillation. Europace, 17(8), 1229-1235. 
5. Reddy, V., Dukkipati, S., Neuzil, P., Natale, A., Albenque, J. Shah, D., … Mansour, M. (2015). Randomized controlled trial of the safety and effectiveness of a contact force sensing irrigated catheter for ablation of paroxysmal atrial fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) study. Circulation, 132 (10), 907-915. http://dx.doi.org/10.1161/CIRCULATIONAHA.114.014092. Optimal CF contact defined as those patients where ≥ 90% lesions ≥ 10 g. Nonoptimal CF contact defined as those patients where ˂90% lesions ≥ 10 g. Direct comparisons between studies are not possible due to differences between study methodology. Repeat ablation after the protocol defined 3-month blanking period, protocol defined success used for analysis. 
6. Bourier, F., Gianni, C., Dare, M., Deisenhofer, I., Hessling, G., Reents, T., . . . Al-Ahmad, A. (2017). Fiberoptic contact-force sensing electrophysiological catheters: how precise is the technology? Journal of Cardiovascular Electrophysiology, 28(1), 109-114. http://dx.doi.org/10.1111/jce.13100 
7. Natale, A., Reddy, V. Y., Monir, G., Wilber, D. J., Lindsay, B. D., McElderry, H. T., … Marchlinski, F. E. (2014) Paroxysmal AF catheter ablation with a contact force sensing catheter: Results of the prospective, multicenter SMART-AF trial. Journal of the American College of Cardiology, 19 (64), 647-656. http://dx.doi.org/10.1016/j.jacc.2014.04.072
8. Mansour, M. (2016, January). Contact force sensing in AF ablation: A health-economic analysis. Presented at the meeting of the AF Symposium, Orlando, FL 
9. Mansour, M., Karst, E., Heist, E. K., Dalal, N., Wasfy, J. H., Packer, D. L., … Mahapatra, S. (2016). The impact of first procedure success rate on the economics of atrial fibrillation ablation. Journal of the American College of Cardiology: Clinical Electrophysiology. Available online 3 August 2016. http://dx.doi.org/10.1016/j.jacep.2016.06.002 
10. Bourier F, Deisenofer I, Hessling G, et al. (2016, May). Contact force sensing electrophysiological catheters: How accurate is the technology? [Abstract PO03-170]. Presented at HRS 2016, San Francisco, CA. Heart Rhythm. 2016;13(5 Suppl 1):S318-S319

 

 

MEASURING CONTACT FORCE THROUGH WHITE LIGHT INTERFEROMETRY

Using light interferometry, the TactiCath™ Quartz Catheter makes an interference analysis to compute both magnitude and orientation of contact force. 

  • A cylindrical titanium sensor that contains 3 gaps (cavities) spaced evenly around the sensor is welded to the tip of the ablation catheter.
  • When a pressure is applied to the tip, the width of the gap changes based on the pressure.
  • Fiber optics based on Fabry-Pérot interferometry are used to measure this gap.

 

graphic showing different light beams and their directions

 

DESIGNED FOR SEAMLESS INTEGRATION

The intuitive display of contact force data allows for enhanced workflow. The EnSite™ contact force module shows the CF data on the EnSite Precision™ cardiac mapping system  providing a single integrated display.

The TactiCath Quartz ablation catheter is also compatible with the following Abbott products:

  • Ampere™ RF Ablation Generator
  • WorkMate Claris™ System
  • VantageView™ System

 

COMPREHENSIVE CARDIAC ABLATION THERAPY AND ARRHYTHMIA MANAGEMENT

The TactiCath Quartz ablation catheter is one of our featured electrophysiology products. As a leader in ablation and mapping technology, our vision is to transform the treatment of cardiac arrhythmias by designing outcome-driven and cost-effective technologies. Read more about our approach to electrophysiology.

 

RESOURCES AND DOCUMENTATION

Product Manuals (Instructions for Use)

TactiCath™ Quartz Ablation Catheter Clinical Compendium

 

VIEW ELECTROPHYSIOLOGY PRODUCT CATALOG
View Product Catalog

TACTICATH™ QUARTZ

Contact Force Ablation Catheter

Open-irrigated 7 F ablation catheter with 75 or 65 mm steerable curve

 

TECHNICAL SPECIFICATIONS

 

Model Number

Description

Curve
(mm)

French
Size

Electrode Spacing (mm)

Tip Electrode (mm)

Length (cm)

PN-004 075

Irrigated Ablation Catheter
(6 hole)

75

7

2 - 5 - 2

3.5

115

PN-004 065

Irrigated Ablation Catheter
(6 hole)

65

7

2 - 5 - 2

3.5

115

 

VIEW ELECTROPHYSIOLOGY PRODUCT CATALOG
View Product Catalog
INDICATIONS, SAFETY & WARNINGS
INDICATIONS, SAFETY & WARNINGS

TactiCath Quartz Ablation Catheter

CAUTION: This product is intended for use by or under the direction of a physician.  Prior to use, reference Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

Indications: The TactiCath Quartz Contact Force Ablation Catheter is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible RF generator and three-dimensional mapping system. 

Contraindications: Do not use for any of the following conditions: certain recent heart surgery; prosthetic valves; active systemic infection; use in coronary vasculature; myxoma or intracardiac thrombus, or an interatrial baffle or patch; retrograde trans-aortic approach in patients with aortic valve replacement. 

Warnings: It is important to carefully titrate RF power; too high RF power during ablation may lead to perforation caused by steam pop. Contact force in excess of 70 g may not improve the characteristics of lesion formation and may increase the risk for perforation during manipulation of the catheter. Patients undergoing septal accessory pathway ablation are at risk for complete AV block which requires the implantation of a permanent pacemaker. Implantable pacemakers and implantable cardioverter/defibrillator may be adversely affected by RF current. Always verify the tubing and catheter have been properly cleared of air prior to inserting the catheter into the vasculature since entrapped air can cause potential injury or fatality. The temperature data transmitted by the sensor in this catheter is representative of the irrigated electrode only and does not provide tissue temperature data. 

Precautions: The long-term risks of protracted fluoroscopy and creation of RF induced lesions have not been established; careful consideration must be given for the use of the device in prepubescent children. When using the catheter with conventional EP lab system or with a 3D navigational system, careful catheter manipulation must be performed, in order to avoid cardiac damage, perforation, or tamponade. Always maintain a constant saline irrigation flow to prevent coagulation within the lumen of the catheter. Access the left side of the heart via a transseptal puncture. Care should be taken when ablating near structures such as the sino-atrial and AV nodes. 

Potential Adverse Events: Potential adverse events include, but are not limited to, cardiovascular related complications, including groin hematoma, pericardial effusion and infection. More serious complications are rare, which can include damage to the heart or blood vessels; blood clots (which may lead to stroke); tamponade; severe pulmonary vein stenosis; heart attack; esophageal fistula, or death. Please refer to the Instructions for Use for a complete list. 

LATEST
ECONOMIC DATA

Dr. Moussa Mansour reveals the important economic benefit of
first-procedure success using TactiCath™ Quartz contact force ablation catheter in AF ablation.

 

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