Paroxysmal AF Catheter Ablation With a Contact Force Sensing Catheter: Results of the Prospective, Multicenter SMART-AF Trial Journal Article

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Authors: Natale, A.; Reddy, V. Y.; Monir, G.; Wilber, D. J.; Lindsay, B. D.; McElderry, H. T.; Kantipudi, C.; Mansour, M. C.; Melby, D. P.; Packer, D. L.; Nakagawa, H.; Zhang, B; Stagg, R. B.; Boo, L. M.; Marchlinski, F. E.
Article Title: Paroxysmal AF Catheter Ablation With a Contact Force Sensing Catheter: Results of the Prospective, Multicenter SMART-AF Trial
Abstract: BACKGROUND: Catheter ablation is important for treatment of paroxysmal atrial fibrillation (PAF). Limited animal and human studies suggest a correlation between electrode-tissue contact and radiofrequency lesion generation. OBJECTIVES: The study sought to assess the safety and effectiveness of an irrigated, contact force (CF)-sensing catheter in the treatment of drug refractory symptomatic PAF. METHODS: A prospective, multicenter, nonrandomized study was conducted. Enrollment criteria included: >/=3 symptomatic episodes of PAF within 6 months of enrollment and failure of >/=1 antiarrhythmic drug (Class I to IV). Ablation included pulmonary vein isolation with confirmed entrance block as procedural endpoint. RESULTS: A total of 172 patients were enrolled at 21 sites, where 161 patients had a study catheter inserted and 160 patients underwent radiofrequency application. Procedural-related serious adverse events occurring within 7 days of the procedure included tamponade (n = 4), pericarditis (n = 3), heart block (n = 1, prior to radiofrequency application), and vascular access complications (n = 4). By Kaplan-Meier analyses, 12-month freedom from atrial fibrillation/atrial flutter/atrial tachycardia recurrence was 72.5%. The average CF per procedure was 17.9 +/- 9.4 g. When the CF employed was between investigator selected working ranges >/=80% of the time during therapy, outcomes were 4.25 times more likely to be successful (p = 0.0054; 95% confidence interval: 1.53 to 11.79). CONCLUSIONS: The SMART-AF trial demonstrated that this irrigated CF-sensing catheter is safe and effective for the treatment of drug refractory symptomatic PAF, with no unanticipated device-related adverse events. The increased percent of time within investigator-targeted CF ranges correlates with increased freedom from arrhythmia recurrence. Stable CF during radiofrequency application increases the likelihood of 12-month success. (THERMOCOOL(R) SMARTTOUCH(R) Catheter for Treatment of Symptomatic Paroxysmal Atrial Fibrillation; NCT01385202).
Journal Title: Journal of the American College of Cardiology
Volume: 64
Issue: 7
ISSN: 1558-3597; 0735-1097
Publisher: Elsevier Inc  
Journal Place: United States
Date Published: 2014
Start Page: 647
End Page: 656
Language: eng
DOI/URL:

10.1016/j.jacc.2014.04.072
Notes: CI: Copyright (c) 2014; JID: 8301365; OTO: NOTNLM; 2014/02/03 [received]; 2014/04/01 [revised]; 2014/04/06 [accepted]; ppublish