Clinical Evidence

Clinical Evidence

Biosense Webster, Inc. is committed to the dissemination of peer-reviewed scientific evidence. 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.

ATTEST Prospective, Multicenter, Randomized Study

ATTEST Prospective, Multicenter, Randomized 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 controlled study to introduce progression from paroxysmal to persistent AF as a clinical endpoint in an AF study. ATTEST demonstrated that early radiofrequency catheter ablation—as part of standard-of-care AF management including antiarrhythmic drugs—is superior to guideline-directed antiarrhythmic drugs therapy alone in delaying AF progression. Patients receiving radiofrequency ablation were approximately 10x less likely to progress to persistent AF than those receiving antiarrhythmic drugs.

PRECEPT study summary image

PRECEPT Prospective, Multicenter 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.

Positive clinical benefit on patient care, quality of life, and symptoms after contact force-guided radiofrequency ablation in persistent atrial fibrillation: Analyses from the PRECEPT prospective multicenter study
Natale A, et al. Circ Arrhythm Electrophysiol. 2021;14(1):e008867.

PRECEPT evaluated safety/effectiveness of persistent AF radiofrequency catheter 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 documented symptomatic recurrence) at 15 months. Patients experienced clinically meaningful improvement in quality of life, AF symptoms, AAD use, cardioversion, and cardiovascular hospitalizations.

Summary image of OCTARAY™ Mapping Catheter first-in-human study

First-in-Human Experience With OCTARAY™ Mapping Catheter With TRUERef™ Technology

An early multicenter experience of the novel high-density star-shaped mapping catheter in complex arrhythmias 
J Interv Card Electrophysiol. 2022;64(1):223-232. 

First-in-human experience with OCTARAY™ Mapping Catheter with TRUERef™ Technology showed good safety profile and positive physician feedback 

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Summary image of study comparing radiofrequency and cryoballoon ablation outcomes

AF Ablation Outcomes in Patients Treated With Radiofrequency or Cryoballoon catheters

Atrial fibrillation ablation with advanced radiofrequency catheter versus second-generation cryoballoon catheter
J Comp Eff Res. 2022;11(9):659-668.

This retrospective cohort study examined costs and 12-month readmission of AF patients undergoing catheter ablation with THERMOCOOL SMARTTOUCH® SF Catheter or Arctic Front Advance™ cryoballoon catheter.

The study found that patients treated with THERMOCOOL SMARTTOUCH® SF Catheter experienced:

  • 21% lower supply cost
  • 10% lower combined procedural and readmission costs
  • 34% lower odds of 12-month AF-related inpatient readmissions

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Same-day discharge summary image

Same-Day Discharge of AF Ablation in Low-Risk Patients

Prospective implementation of a same-day discharge protocol for catheter ablation of paroxysmal atrial fibrillation.
Rajendra A, et al. J Interv Card Electrophysiol. Published online November 21, 2020. doi: 10.1007/s10840-020-00914-8.

This real-world study implemented a specific protocol to prospectively identify low-risk paroxysmal AF patients suitable for same-day discharge and a postprocedural checklist to safely execute same-day discharge after ablation facilitated by contemporary radiofrequency catheter ablation technology.

Same day discharge protocol success:

  • 93% of low-risk patients prospectively identified for same-day discharge went home after an 8-hr observation period
  • No safety differences were observed between patients going home on the same day and those staying overnight

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Healthcare utilization after catheter ablation summary image

Healthcare Utilization Before and After AF Catheter Ablation

Catheter ablation and healthcare utilization and cost among patients with paroxysmal versus persistent atrial fibrillation.
Friedman DJ, et al. Heart Rhythm O2. 2021;2(1):28-36.

This retrospective, observational cohort study examined if ablation would be associated with reductions in 12-month AF-related healthcare utilization in patients with paroxysmal (PAF) and persistent atrial fibrillation (PsAF).

The study found that after ablation there were:

  • 70%/67% fewer inpatient admissions for PAF/PsAF patients, respectively
  • 73%/62% fewer emergency department visits for PAF/PsAF patients, respectively
  • 54%/58% fewer cardioversions for PAF/PsAF patients, respectively

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SMART SF study summary image


Safety and efficiency of porous-tip contact-force catheter for drug-refractory symptomatic paroxysmal atrial fibrillation ablation: Results from the SMART SF trial
Chinitz LA, et al. Europace. 2018;20(Fl_3):f392-f400.

Long-term safety and effectiveness of paroxysmal atrial fibrillation ablation using a porous tip contact force-sensing catheter from the SMART SF trial
Natale A, et al. J Interv Card Electrophysiol. Published online May 27, 2020. doi: 10.1007/s10840-020-00780-4.

The multicenter, nonrandomized SMART SF evaluated the safety and efficiency of the THERMOCOOL SMARTTOUCH® SF Catheter with CARTO VISITAG™ Module for symptomatic, drug refractory paroxysmal atrial fibrillation.

SMART SF study outcomes: 

  • 96.2% acute procedural effectiveness
  • 2.5% primary adverse event rate
  • 74.9% freedom from recurrence at 12-months

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Atrioesophageal Fistula clinical evidence

Atrioesophageal Fistula Safety

Comparing rates of atrioesophageal fistula with contact force-sensing and non-contact force-sensing catheters: Analysis of post-market safety surveillance data
Calkins H, et al. J Interv Card Electrophysiol. 2020;59(1):49-55.

A retrospective data analysis determined atrioesophageal fistula rates associated with the use of contact force sensing and non-contact force-sensing catheters.

Retrospective analysis outcomes:

  • Contact-force sensing catheters were used 2 to 5 times more frequently in left atrial procedures
  • Atrioesophageal fistula rates: 0.006% for contact-force sensing catheters versus 0.005% for non-contact force-sensing catheters
  • Atrioesophageal fistula events are associated with the use of high power, high force, and long radiofrequency duration

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Additional Clinical Evidence

  • Calkins H, Gache L, Frame D, et al. Predictive value of atrial fibrillation during the postradiofrequency ablation blanking period. Heart Rhythm 2021;18(3):366-373.
  • Macle L, Frame D, Gache LM, et al. Atrial fibrillation ablation with a spring sensor-irrigated contact force sensing catheter compared with other ablation catheters: Systematic literature review and meta-analysis. BMJ Open  2019;9(6):e023775.
  • Zei PC, Hunter TD, Gache LM, O'Riordan G, Baykaner T, Brodt CR. Low-fluoroscopy atrial fibrillation ablation with contact force and ultrasound technologies: A learning curve. Pragmat Obs Res. 2019;10:1-7.
  • De Potter T, Van Herendael H, Balasubramaniam R, et al. 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. 2018;20(FI_3):f410-f418.
  • Reddy VY, Pollak S, Lindsay BD, et al. Relationship between catheter stability and 12-month success after pulmonary vein isolation: A subanalysis of the SMART-AF Trial.  JACC Clin Electrophysiol. 2016;2(6):691-699.
  • Marchlinski FE, Haffajee CI, Beshai JF, Dickfeld T-ML, Gonzalez MD, Hsia HH, et al. Long-term success of irrigated radiofrequency catheter ablation of sustained ventricular tachycardia: Post-approval THERMOCOOL VT trial. J Am Coll Cardiol. 2016;67(6):674-683.
  • Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: Results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014;64(7):647-56.
  • Oza SR, Hunter TD, Biviano AB, et al. Acute safety of an open-irrigated ablation catheter with 56-hole porous tip for radiofrequency ablation of paroxysmal atrial fibrillation: analysis from 2 observational registry studies. J Cardiovasc Electrophysiol. 2014;25(8):852-858.
  • Waldo AL, Wilber DJ, Marchlinski FE, et al. Safety of the open-irrigated ablation catheter for radiofrequency ablation: safety analysis from six clinical studies. Pacing Clin Electrophysiol. 2012;35(9):1081-1089.
  • Wilber DJ, Pappone C, Neuzil P, et al. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: A randomized controlled trial. JAMA. 2010;303(4):333-340.
  • Stevenson WG, Wilber DJ, Natale A, et al. Irrigated radiofrequency catheter ablation guided by electroanatomic mapping for recurrent ventricular tachycardia after myocardial infarction: The multicenter Thermocool Ventricular Tachycardia Ablation trial. Circulation. 2008;118(25):2773-2782.

The THERMOCOOL SMARTTOUCH® SF Catheter is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (AF) and for drug refractory recurrent symptomatic persistent AF (continuous AF > 7 days but < 1 year), refractory or intolerant to at least 1 Class I or III AAD, when used with the CARTO® 3 System.

The CARTO VISITAG™ Module provides access to data collected during the application of RF energy. The data does not indicate the effectiveness of RF energy application. CARTO VISITAG™ Module settings are user defined based on the user’s clinical experience and medical judgment. Biosense Webster, Inc. does not recommend any settings for the CARTO VISITAG™ Module.

DO NOT use OCTARAY™ Mapping Catheter with TRUEref™ Technology in patients with prosthetic valves.

The third-party trademarks used herein are the properties of their respective owners.

Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions. Caution: US law restricts this device to sale by or on the order of a physician.

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