Clinical Evidence

Clinical Evidence

Biosense Webster, Inc. is committed to the dissemination of scientific evidence in peer-reviewed journals. We are proud of our track record of publishing cutting-edge clinical research that fuels the development of devices, which provide novel alternatives for the treatment of complex heart arrhythmias.

Clinical Evidence
VISTAX Prospective, Multicenter, Nonrandomized Study

VISTAX Prospective, Multicenter, Nonrandomized Study

Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions: The multicentre VISTAX trial. Duytschaever M, et al. Europace. 2021;23(3):362-369.

VISTAX demonstrated the reproducibility of an optimized VISITAG SURPOINT™ Module PVI ablation workflow in patients with drug refractory paroxysmal AF treated in 17 European sites. ~90% of patients were free of arrhythmia recurrence or repeat ablation at 12-month.
 

Watch Video Summaries

VISTAX study presentation

VISTAX study presentation

Optmized PVI Workflow – Step-by-Step

Optmized PVI Workflow – Step-by-Step

Optimized PVI Workflow- Tips and Tricks

Optimized PVI Workflow- Tips and Tricks

PRECEPT Prospective, Multicenter, Nonrandomized Study

PRECEPT Prospective, Multicenter, Nonrandomized Study

Persistent atrial fibrillation ablation with contact force-sensing catheter: The prospective multicenter PRECEPT trial
Mansour M,  et al. JACC Clin Electrophysiol. 2020;6(8):958-969.  

PRECEPT evaluated safety/effectiveness of persistent atrial fibrillation ablation with the contact-force sensing THERMOCOOL SMARTTOUCH™ SF Catheter and CARTO VISITAG™ Module using a tailored PVI-only/PVI+ approach. 80% of patients experienced clinical success (ie, freedom from symptomatic recurrence) at 15 months.

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ATTEST Prospective, Multicenter, Randomized Controlled Study

ATTEST Prospective, Multicenter, Randomized Controlled Study

Catheter ablation or medical therapy to delay progression of atrial fibrillation: The randomized controlled atrial fibrillation progression trial (ATTEST) Kuck, K-H, et al. Europace. 2021;23(3):362-369.

ATTEST was the first randomized study demonstrating that early RF catheter ablation is superior to antiarrhythmic drug therapy in delaying AF progression. RF ablation patients were approximately 10x less likely to progress to persistent AF.

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Standardization of AF Ablation Workflow With THERMOCOOL SMARTTOUCH© CATHETER and VISITAG SURPOINT™ Module

Standardization of AF Ablation Workflow With THERMOCOOL SMARTTOUCH© CATHETER and VISITAG SURPOINT™ Module

De Potter T, et al. J Interv Card Electrophysiol. 2020:59(1):21-27

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Meta-Analysis THEMOCOOL SMARTTOUCH® Catheter Ablation vs Other Technologies

Meta-Analysis THEMOCOOL SMARTTOUCH® Catheter Ablation vs Other Technologies

Macle L, et al. BMJ Open. 2019;9(6):e023775.

 

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Standardization of AF Ablation Workflow With THERMOCOOL SMARTTOUCH© CATHETER and CARTO VISITAG™ Module

Standardization of AF Ablation Workflow With THERMOCOOL SMARTTOUCH© CATHETER and CARTO VISITAG™ Module
 

Osorio J, et al. J Atr Fibrillation. 2018;11(4):2097.

 

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Additional Clinical Evidence

  • Calkins, H. et al (2020). Comparing rates of atrioesophageal fistula with contact force-sensing and non-contact force-sensing catheters: analysis of post-market safety surveillance data. Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 59(1), 49–55. Retrieved March 31, 2021 from https://doi.org/10.1007/s10840-019-00653-5 
  • Natale, A. et al (2020). Long-term safety and effectiveness of paroxysmal atrial fibrillation ablation using a porous tip contact force-sensing catheter from the SMART SF trial. Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 10.1007/s10840-020-00780-4. Advance online publication. Retrieved March 31, 2021 from https://doi.org/10.1007/s10840-020-00780-4 
  • Ioannou, A. et al (2020). Efficacy and safety of ablation index-guided catheter ablation for atrial fibrillation: an updated meta-analysis. Europace: European pacing, arrhythmias, and cardiac electrophysiology: Journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 22(11), 1659–1671. Retrieved March 31, 2021 from https://doi.org/10.1093/europace/euaa224 
  • Stabile, G. et al (2020). Reproducibility of pulmonary vein isolation guided by the ablation index: 1-year outcome of the AIR registry. Journal of cardiovascular electrophysiology, 31(7), 1694–1701. Retrieved March 31, 2021 from https://doi.org/10.1111/jce.14531 
  • Gupta, D. et al (2020). Comparative effectiveness of catheter ablation devices in the treatment of atrial fibrillation: a network meta-analysis. Journal of comparative effectiveness research, 9(2), 115–126. Retrieved March 31, 2021 from https://doi.org/10.2217/cer-2019-0165 
  • Hussein, A. et al (2020). Treatment of Atrial Fibrillation Using Ablation Index-Guided Contact Force Ablation: A Matching-Adjusted Indirect Comparison to Cryoballoon Ablation. Advances in therapy, 37(2), 785–799. Retrieved March 31, 2021 from https://doi.org/10.1007/s12325-019-01173-4 
  • Duytschaever, M. et al (2020). Long-term impact of catheter ablation on arrhythmia burden in low-risk patients with paroxysmal atrial fibrillation: The CLOSE to CURE study. Heart rhythm, 17(4), 535–543. Retrieved March 31, 2021, from https://doi.org/10.1016/j.hrthm.2019.11.004 
  • Santoro, F. et al (2019). Left atrial anterior line ablation using ablation index and inter-lesion distance measurement. Clinical research in cardiology : official journal of the German Cardiac Society, 108(9), 1009–1016. Retrieved March 31, 2021, from https://doi.org/10.1007/s00392-019-01428-8 
  • Halbfass, P. et al (2019). Incidence of acute thermal esophageal injury after atrial fibrillation ablation guided by prespecified ablation index. Journal of cardiovascular electrophysiology, 30(11), 2256–2261. Retrieved March 31, 2021, from https://doi.org/10.1111/jce.14193 
  • Berte, B. et al (2020). Pulmonary vein isolation using ablation index vs. CLOSE protocol with a surround flow ablation catheter. Europace: European pacing, arrhythmias, and cardiac electrophysiology: Journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 22(1), 84–89. Retrieved March 31, 2021, from https://doi.org/10.1093/europace/euz244 
  • O'Neill, L. et al (2019). Pulmonary vein encirclement using an Ablation Index-guided point-by-point workflow: cardiovascular magnetic resonance assessment of left atrial scar formation. Europace: European pacing, arrhythmias, and cardiac electrophysiology : Journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 21(12), 1817–1823. Retrieved March 31, 2021, from https://doi.org/10.1093/europace/euz226 
  • Pranata, R. et al (2019). Ablation-index guided versus conventional contact-force guided ablation in pulmonary vein isolation - Systematic review and meta-analysis. Indian pacing and electrophysiology journal, 19(4), 155–160. Retrieved March 31, 2021, from https://doi.org/10.1016/j.ipej.2019.05.001 
  • Lee, S. R. et al (2019). Efficacy of the optimal ablation index-targeted strategy for pulmonary vein isolation in patients with atrial fibrillation: the OPTIMUM study results. Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 55(2), 171–181. Retrieved March 31, 2021, from https://doi.org/10.1007/s10840-019-00565-4 
  • Solimene, F. et al (2019). Reproducibility of acute pulmonary vein isolation guided by the ablation index. Pacing and clinical electrophysiology : PACE, 42(7), 874–881. Retrieved March 31, 2021, from https://doi.org/10.1111/pace.13710 
  • Casella, M. et al (2020). An ablation index operator-independent approach to improve efficacy in atrial fibrillation ablation at 24-month follow-up: a single center experience. Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 57(2), 241–249. Retrieved March 31, 2021, from https://doi.org/10.1007/s10840-019-00587-y 
  • Dhillon, G. et al (2019). A multicentered evaluation of ablation at higher power guided by ablation index: Establishing ablation targets for pulmonary vein isolation. Journal of cardiovascular electrophysiology, 30(3), 357–365. Retrieved March 31, 2021, from https://doi.org/10.1111/jce.13813 
  • Wolf, M. et al (2019). Endoscopic evaluation of the esophagus after catheter ablation of atrial fibrillation using contiguous and optimized radiofrequency applications. Heart rhythm, 16(7), 1013–1020. Retrieved March 31, 2021, from https://doi.org/10.1016/j.hrthm.2019.01.030 
  • Pedrote, A. et al (2019). Analysis of late reconnections after pulmonary vein isolation: Impact of interlesion contiguity and ablation index. Pacing and clinical electrophysiology : PACE, 42(6), 678–685. Retrieved March 31, 2021, from https://doi.org/10.1111/pace.13673 
  • Casella, M. et al (2019). Ablation Index as a predictor of long-term efficacy in premature ventricular complex ablation: A regional target value analysis. Heart rhythm, 16(6), 888–895. Retrieved March 31, 2021, from https://doi.org/10.1016/j.hrthm.2019.01.005 
  • De Pooter, J. et al (2019). Pulmonary Vein Reconnection No Longer Occurs in the Majority of Patients After a Single Pulmonary Vein Isolation Procedure. JACC. Clinical electrophysiology, 5(3), 295–305. Retrieved March 31, 2021, from https://doi.org/10.1016/j.jacep.2018.11.020 
  • Solimene, F. et al (2019). Safety and efficacy of atrial fibrillation ablation guided by Ablation Index module. Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 54(1), 9–15. Retrieved March 31, 2021, from https://doi.org/10.1007/s10840-018-0420-5 
  • Zei, P. C. et al (2019). Low-fluoroscopy atrial fibrillation ablation with contact force and ultrasound technologies: a learning curve. Pragmatic and observational research, 10, 1–7. Retrieved March 31, 2021, from https://doi.org/10.2147/POR.S181220 
  • De Potter, T. et al (2018). Safety and long-term effectiveness of paroxysmal atrial fibrillation ablation with a contact force-sensing catheter: real-world experience from a prospective, multicentre observational cohort registry. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 20(FI_3), f410–f418. Retrieved March 31, 2021, from https://doi.org/10.1093/europace/eux290 
  • Reddy, V. Y. et al (2016). Relationship Between Catheter Stability and 12-Month Success After Pulmonary Vein Isolation: A Subanalysis of the SMART-AF Trial. JACC. Clinical electrophysiology, 2(6), 691–699. Retrieved March 31, 2021, from https://doi.org/10.1016/j.jacep.2016.07.014 
  • Marchlinski, F. E. et al (2016). Long-Term Success of Irrigated Radiofrequency Catheter Ablation of Sustained Ventricular Tachycardia: Post-Approval THERMOCOOL VT Trial. Journal of the American College of Cardiology, 67(6), 674–683. Retrieved March 31, 2021, from https://doi.org/10.1016/j.jacc.2015.11.041 
  • Natale, A. et al (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, 64(7), 647–656. Retrieved March 31, 2021, from https://doi.org/10.1016/j.jacc.2014.04.072 

The CARTO VISITAG™ Module provides access to data collected during the application of RF energy. The Tag Index values should not be used to guide RF energy delivery. 

Important information: Prior to use, refer to the instructions for use supplied with the device for indications, contraindications, side effects, warnings and precautions. 


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