TactiCath™ Family of Contact Force Ablation Catheters | Abbott Cardiovascular
CARDIOVASCULAR
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ACCURACY MATTERS – SEE THINGS DIFFERENTLY

Our TactiCath™ family of contact force ablation catheters includes two cutting-edge catheters that are innovative solutions for the treatment of atrial fibrillation (AF). The TactiCath™ contact force ablation catheter, Sensor Enabled™ offers procedural effectiveness and is fully integrated with the EnSite Precision™ cardiac mapping system. The TactiCath™ Quartz ablation catheter provides contact force measurements in real-time. The Abbott contact force ablation catheters enhance 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.

THIS DEVICE IS COMMERCIALLY AVAILABLE FOR USE IN SELECT INTERNATIONAL MARKETS.
ONLY ONE HAS 6X GREATER ACCURACY IN CONTACT FORCE SENSING*****1,15

The TactiCath™ Quartz ablation catheter, has proven greater accuracy in contact force sensing than ThermoCool SmartTouch‡ SF catheter.*****1,15

 

  • There was ≤ 1.2 g mean absolute difference between the force reading and actual force of the TactiCath™ ablation catheter. The ThermoCool SmartTouch SF catheter showed a 6.0 g mean absolution difference.1,15*****

ADVANCED SOLUTIONS FOR AF

  • Building on the advanced features of the TactiCath™ Quartz contact force ablation catheter, TactiCath™ contact force ablation catheter, Sensor Enabled™* elevates procedural effectiveness and efficiency through accurate1,2, effortless***,3-6 and integrated7,8 performance. With advanced handle and shaft technology and full integration with the EnSite Precision™ cardiac mapping system.
  • 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 tissue surface. Contact force feedback may assist in the creation of safe, effective and durable lesions.9-12
SEE THE RESULTS

Supported by clinical evidence, our TactiCath™ Quartz contact force ablation catheter technology offers you accuracy, efficiency and results you can rely on. The TactiCath Quartz catheter also demonstrated higher accuracy in axial and parallel orientations in an independent head-to-head comparison with the ThermoCool SmartTouch‡ SF catheter.*****1,15

Accuracy graphs
FEEL THE DIFFERENCE

Discover the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™, which is uniquely designed for effortless performance***,3-6 and offers consistent and comfortable usability:

  • The advanced handle-shaft combination offers reduced physical strain and optimal maneuverability for performance consistency.***,3-6
  • Using bidirectional or select unidirectional handle with symmetric and asymmetric curves offers you the opportunity to gain additional reach.
TactiCath features
DISCOVER THE SYNERGY

Seamless integration with EnSite Precision™ cardiac mapping system enables automated,13 flexible**13 and precise14 performance and is designed to improve patient outcomes****,11,12 and workflow efficiency.

  • Procedural consistency may increase through automated guidance of lesion marking via the AutoMark feature.7
  • Verify ablation catheter stability and AutoMark placement with the AutoTrack feature, which automatically records the precise location of the tip during RF during energy application.7

Learn more about the technology of the revolutionary TactiCath™ family of contact force ablation catheters.

COMPREHENSIVE CARDIAC ARRHYTHMIA MANAGEMENT

The TactiCath™ family of contact force ablation catheters are part of our cardiac arrhythmia management portfolio. 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 cardiac arrhythmias management.

RESOURCES AND DOCUMENTATION
REFERENCES

*The TactiCath™ contact force ablation catheter, Sensor Enabled™ is an update to the TactiCath™ contact force catheter family using the FlexAbility™ catheter family platform handle and shaft and a tip and force sensor derived from the TactiCath™ Quartz catheter. TactiCath™ and TactiCath™ Quartz contact force ablation catheter clinical data are applicable to the TactiCath™ ablation catheter, Sensor Enabled as mechanical/function testing and preclinical studies have demonstrated equivalent performance and safety profile. See Abbott, data on file, Report 90195941.
** The open-platform feature of the EnSite Precision™ cardiac mapping system allows for use of almost any catheter, thus offering superior flexibility as compared to Biosense Webster’s Carto™‡ system, which limits use to Biosense Webster‡ catheters only. ***Effortless is based on comparison of the TactiCath™ contact force ablation catheter, Sensor Enabled™ to the TactiCath™ contact force ablation catheter from physician feedback on catheter handling performance between the two catheters during preclinical and bench testing comparing the two catheters with respect to torque response and actuation force.
****Refers to the use of TactiCath™ Quartz ablation catheter when using contact force recommendations. The EnSite™ contact force module integrates the TactiCath™ Quartz ablation catheter.
***** 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.15
1. 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
2. Yokoyama, K., Nakagawa, H., Shah, D. C., Lambert, H., Leo, G., Aeby, N., … Jackman, W. M. (2008). Novel contact force sensor incorporated in irrigated radiofrequency ablation catheter predicts lesion size and incidence of steam pop and thrombus. Circulation: Arrhythmia and Electrophysiology, 1, 354-362. http://dx.doi.org/10.1161/CIRCEP.108.803650
3. Abbott. Data on file, Report 90247461.
4. Abbott. Data on file, Report 90211752.
5. Abbott. Data on file, Report 90223883.
6. Abbott. Data on file, Report C278453.
7. Abbott. Data on file, Report 90214738.
8. Abbott. Data on file, Report 90253949.
9. 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.
10. 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
11. 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
12. 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
13. Ptaszek, L., Moon, B., Sacher, F., Jais, P, Mahapatra, S. & Mansour, M. (2015). A novel tool for mapping multiple rhythms from a single mapping procedure. Poster abstract P849. Europace, 17(Suppl. 3), iii115. https://academic.oup.com/europace/article/17/suppl_3/iii108/2483490/POSTER-SESSION-3
14. Abbott. Data on file, Report 90237452.
15. 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.

INNOVATIVE TECHNOLOGIES FOR EFFECTIVE AF TREATMENT

ENHANCED WORKFLOW AND 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™ family of contact force ablation catheters is also compatible with the following St. Jude Medical™ products: 

  • Ampere™ RF Ablation Generator
  • WorkMate Claris™ Cardiac Mapping System
  • VantageView™ Cardiac Mapping System
MEASURING CONTACT FORCE THROUGH WHITE LIGHT INTERFEROMETRY

Using light interferometry, the catheters in the TactiCath™ family of contact force ablation catheters make 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.
TactiCath infographic
TACTICATH™ FAMILY OF CONTACT FORCE ABLATION CATHETERS FEATURES AND REQUIREMENT

The main features of these advanced ablation catheters include:

  • Force sensor at the distal catheter tip
  • Fiber optic technology for optimal stability during contact force measurement
  • TactiCath™ Quartz catheter offers 65 or 75 mm deflectable curve
  • Requires TactiSys™ Quartz hardware equipment and accessories
  • Compatibility with steerable sheaths (such as the Agilis™ NxT introducer) , resulting in increased stability and contact force—potentially offering more durable lesion formation, with improved long-term outcome1
UNIQUE ADVANTAGES OF THE TACTICATH™ FAMILY OF CONTACT FORCE ABLATION CATHETERS AND THE TACTISYS™ QUARTZ EQUIPMENT

Designed for seamless integration, the TactiSys™ Quartz equipment 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 
  • 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 labeling2,3 
  • The LSI™ Index (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 ARRHYTHMIA MANAGEMENT

The TactiCath™ family of contact force ablation catheters are part of our cardiac arrhythmia management portfolio. 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
REFERENCES

1. 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
2. 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
3. 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

IMPROVING ADVANCED ABLATION WITH COMPREHENSIVE CLINICAL STUDIES

Over the years, the TactiCath™ ablation catheters have been involved in a comprehensive set of clinical studies1-4,6 on contact force (CF) sensing; these studies provide evidence to recommend contact force management to optimize patient outcomes.1-4

Data from studies such as TOCCATA, EFFICAS I and EFFICAS II show that 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.5

TACTICATH™ ABLATION CATHETER STUDY HIGHLIGHTS
TactiCath study highlights
CONTACT FORCE RECOMMENDATIONS3,4
TOCCASTAR features
TOCCASTAR EFFECTIVENESS: OPTIMAL CONTACT FORCEa CLINICAL STUDIES6
TOCCASTAR clinical trial graphic
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.2
  • 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

Contact force ablation chart
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™ Index values are strong predictors of PVI gap likelihood.3
  • 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).4
  • The EFFICAS I trial provided the CF recommendations of a target CF of 20 g, minimum CF ≥ 10 g, minimum FTI™ Index of 400 gs, targeting transmurality in a single RF application.3
  • EFFICAS II provided clinical validation that following recommendations to optimize catheter contact force (target CF = 20 g, minimum CF ≥ 10 g, minimum FTI™ Index ≥ 400 gs) and creating a contiguous lesion in a single RF application (low CI < 6) can achieve successful PV isolation.4
  • Optimal contact force with the TactiCath ablation catheter and contiguous lesion deployment reduces occurrence of PV gaps at 3 months.4

Read more about the EFFICAS II study:

EFFICAS II: Optimization of Catheter Contact Force Improves Outcome of Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

EFFICAS I AND II CLINICAL STUDY SUMMARY3,4
EFFICAS study chart
EFFICAS I: PVI SUCCESS RATES BY MINIMUM FTI™ INDEX3
EFFICAS II: CONTINUITY INDEX4
EFFICAS lesions chart
EFFICAS I AND EFFICAS II CLINICAL COMPARISION3,4

 

EFFICAS clinical study chart
TOCCASTAR CLINICAL TRIAL6

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.6

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.6 (Previous SMART-AF results reported tamponade at 2.5%.7c)
  • Physicians who used Optimal CFa achieved 12-month clinical success in 85.5% of patients versus 67.7% when Non-optimal CFb was used (p=0.009).6
    • 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 CFb procedures were associated with similar or lower RF power than non-optimal CF procedures.6
  • Furthermore, the Optimal CFa group had fewer repeat ablation procedures (7.2%) than both the Control group (12.7%) and Non-optimal CFb group (16.1%) at 12 months.6
CONTACT FORCE AND CONTROL: RATE OF REPEAT ABLATIONd,6

 

Contact force chart

Read comprehensive information on these clinical studies:

COMPREHENSIVE CARDIAC ARRHYTHMIA MANAGEMENT

The TactiCath™ family of contact force ablation catheters are part of our cardiac arrhythmia management portfolio. 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

Reimbursement Information

REFERENCES

a. Optimal CF contact defined as those patients where ≥ 90% lesions ≥ 10 g.
b. Non-optimal CF contact defined as those patients where ˂90% lesions ≥ 10 g.
c. Direct comparisons between studies are not possible due to differences between study methodology.
d. Repeat ablation after the protocol defined 3-month blanking period, protocol defined success used for analysis.

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., Peichl, P., Petru, J., Cihak, R., Skoda, J., … Kuck, K. (2012). Contact force, force time integral and lesion continuity are critical to improve durable PV isolation: EFFICAS 2 results. Heart Rhythm, 9(5), S28. http://dx.doi.org/10.1016/j.hrthm.2012.03.025 
5. Mansour, M., Karst, E., Dala, N., Heist, E. K., Packer, D., Calkins, H., … Mahapatra, S. (2015, May). Economic impact of repeat ablation for atrial fibrillation. Presented at the meeting of the Heart Rhythm Society, Boston, MA.
6. 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
7. Natale, A., Reddy, V.Y., Monir, G., Wilber, D.J., Lindsay, B.D., McElderry, H.T., … Marchlinski, F.E. 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

TACTICATH™ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED™

IRRIGATED ABLATION CATHETERS
ORDERING INFORMATION

Reorder Number

Description

Curve

French Size

Electrode Spacing (mm)

Tip Electrode (mm)

Length (cm)

A-TCSE-DD

Bi-D Irrigated Ablation Catheter

D-D

8

2-2-2

3.5

115

A-TCSE-DF

Bi-D Irrigated Ablation Catheter

D-F

8

2-2-2

3.5

115

A-TCSE-FF

Bi-D Irrigated Ablation Catheter

F-F

8

2-2-2

3.5

115

A-TCSE-FJ

Bi-D Irrigated Ablation Catheter

F-J

8

2-2-2

3.5

115

A-TCSE-JJ

Bi-D Irrigated Ablation Catheter

J-J

8

2-2-2

3.5

115

A-TCSE-D

Uni-D Irrigated Ablation Catheter

D

8

2-2-2

3.5

115

A-TCSE-F

Uni-D Irrigated Ablation Catheter

F

8

2-2-2

3.5

115

A-TCSE-J

Uni-D Irrigated Ablation Catheter

J

8

2-2-2

3.5

115

SEE FULL PRODUCT DETAILS and any references for this product.

TACTICATH™ QUARTZ CONTACT FORCE ABLATION CATHETER

CONTENTS: OPEN-IRRIGATED 7F ABLATION CATHETER WITH 75 OR 65 MM STEERABLE CURVE
ORDERING INFORMATION

Reorder Number

Description

Curve

French Size

Tip Electrode (mm)

Electrode Spacing (mm)

Length (cm)

PN-004 075

Irrigated Ablation Catheter (6 hole)

75 mm

7

3.5

2 - 5 - 2

115

PN-004 065

Irrigated Ablation Catheter (6 hole)

65 mm

7

3.5

2 - 5 - 2

115

SEE FULL PRODUCT DETAILS and any references for this product.

TACTISYS™ QUARTZ EQUIPMENT

ORDERING INFORMATION

Reorder Number

Description

PN-004 400

TactiSys™ Quartz Equipment

PN-004 515

TactiSys Quartz St. Jude Medical RF Cable

H702500

EnSite™ Contact Force Module v.2.0

SEE FULL PRODUCT DETAILS and any references for this product.

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