TY - JOUR
T1 - Persistent Atrial Fibrillation Ablation With Contact Force–Sensing Catheter
T2 - The Prospective Multicenter PRECEPT Trial
AU - Mansour, Moussa
AU - Calkins, Hugh
AU - Osorio, Jose
AU - Pollak, Scott J.
AU - Melby, Daniel
AU - Marchlinski, Francis E.
AU - Athill, Charles A.
AU - Delaughter, Craig
AU - Patel, Anshul M.
AU - Gentlesk, Philip J.
AU - DeVille, Brian
AU - Macle, Laurent
AU - Ellenbogen, Kenneth A.
AU - Dukkipati, Srinivas R.
AU - Reddy, Vivek Y.
AU - Natale, Andrea
N1 - Funding Information:
The authors thank all the PRECEPT trial investigators. The authors wish to thank the following individuals for their efforts in execution of the trial, statistical analysis, medical writing, and providing valuable input/contribution to the development of this paper: Robert Stagg, Reecha Sharma, Lee Ming Boo, Christina Kaneko, Bharat Kumar Janapala, Yiyang Zhu, Tiffany Tan, and MedErgy HealthGroup. The PRECEPT study was funded and sponsored by Biosense Webster, Inc. Dr. Natale serves as a consultant for Abbott, Biosense Webster, Inc., Biotronik, Boston Scientific, Baylis, and Medtronic. Dr. Mansour has served as a consultant for Biosense Webster, Inc., Abbott, Medtronic, Boston Scientific, Janssen, Philips, Novartis, and Sentre Heart; has received research grants from Biosense Webster, Inc., Abbott, Boston Scientific, Medtronic, Pfizer, and Boehringer Ingelheim; and has an equity interest in EPD Solutions, NewPace Ltd, and Affera. Dr. Calkins has received honoraria and consulting fees from Biosense Webster, Inc., Medtronic, Abbott, Atricure, and Boston Scientific. Dr. Osorio serves as a consultant for Biosense Webster, Inc. and Boston Scientific; and has received honorarium and research grants from Biosense Webster, Inc. and Boston Scientific. Dr. Pollak has received personal fees from Biosense Webster, Inc. Dr. Melby has received honoraria for physician education from Biosense Webster, Inc. Dr. Marchlinski serves as a consultant for Abbott, Medtronic, Biosense Webster, Inc.; and has received honorarium from Biotronik and Boston Scientific. Dr. Athill has received a research grant from Biosense Webster, Inc.; has received honoraria from Janssen; and is a consultant for Abbott and Boston Scientific. Dr. Delaughter serves as a consultant for Biosense Webster, Inc. Dr. Patel has received research grant and personal fees from Biosense Webster, Inc. Dr. DeVille has served as a consultant for Biosense Webster, Inc., Medtronic, and Boston Scientific; and has received honorarium from Biosense Webster, Inc., Medtronic, and Boston Scientific. Dr. Macle has received research grants from Biosense Webster, Inc. and Abbott; and has received honorarium from Biosense Webster, Inc. Dr. Dukkipati has received a research grant from Biosense Webster, Inc. Dr. Reddy has received research grants from Biosense Webster, Inc.; serves as an unpaid consultant to Biosense Webster, Inc; is a consultant to Abbott, Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Autonomix, Axon, Backbeat, BioSig, Biotronik, Boston Scientific, Cardiofocus, Cardionomic, CardioNXT/AFTx, Circa Scientific, Corvia Medical, East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Fire1, Impulse Dynamics, Javelin, Keystone Heart, LuxCath, Manual Surgical Sciences, Medlumics, Medtronic, Middlepeak, Newpace, Nuvera, Philips, Stimda, Surecor, Thermedical, Valcare, and Vizara; and has equity in Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Autonomix, Baclbeat, BioSig, Circa Scientific, Corvia Medical, East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo Farapulse, Fire 1, Javelin, Keystone Heart, LuxCath, Manual Surgical Sciences, Medlumics, Middlepeak, Newpace, Nuvera, Surecor, Valcare, and Vizara. Dr. Ellenbogen serves as a consultant for Biosense Webster, Inc., Medtronic, Boston Scientific, and Abbott; and has received honorarium from Biosense Webster, Medtronic, Boston Scientific, and Abbott. Dr. Natale has served as a consultant for Abbott, Biosense Webster, Inc., Biotronik, Boston Scientific, Baylis, and Medtronic. Dr. Gentlesk has reported that he has no relationships relevant to the contents of this paper to disclose.
Funding Information:
The PRECEPT study was funded and sponsored by Biosense Webster, Inc. Dr. Natale serves as a consultant for Abbott, Biosense Webster, Inc., Biotronik, Boston Scientific, Baylis, and Medtronic. Dr. Mansour has served as a consultant for Biosense Webster, Inc., Abbott, Medtronic, Boston Scientific, Janssen, Philips, Novartis, and Sentre Heart; has received research grants from Biosense Webster, Inc., Abbott, Boston Scientific, Medtronic, Pfizer, and Boehringer Ingelheim; and has an equity interest in EPD Solutions, NewPace Ltd, and Affera. Dr. Calkins has received honoraria and consulting fees from Biosense Webster, Inc., Medtronic, Abbott, Atricure, and Boston Scientific. Dr. Osorio serves as a consultant for Biosense Webster, Inc. and Boston Scientific; and has received honorarium and research grants from Biosense Webster, Inc. and Boston Scientific. Dr. Pollak has received personal fees from Biosense Webster, Inc. Dr. Melby has received honoraria for physician education from Biosense Webster, Inc. Dr. Marchlinski serves as a consultant for Abbott, Medtronic, Biosense Webster, Inc.; and has received honorarium from Biotronik and Boston Scientific. Dr. Athill has received a research grant from Biosense Webster, Inc.; has received honoraria from Janssen; and is a consultant for Abbott and Boston Scientific. Dr. Delaughter serves as a consultant for Biosense Webster, Inc. Dr. Patel has received research grant and personal fees from Biosense Webster, Inc. Dr. DeVille has served as a consultant for Biosense Webster, Inc., Medtronic, and Boston Scientific; and has received honorarium from Biosense Webster, Inc., Medtronic, and Boston Scientific. Dr. Macle has received research grants from Biosense Webster, Inc. and Abbott; and has received honorarium from Biosense Webster, Inc. Dr. Dukkipati has received a research grant from Biosense Webster, Inc. Dr. Reddy has received research grants from Biosense Webster, Inc.; serves as an unpaid consultant to Biosense Webster, Inc; is a consultant to Abbott, Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Autonomix, Axon, Backbeat, BioSig, Biotronik, Boston Scientific, Cardiofocus, Cardionomic, CardioNXT/AFTx, Circa Scientific, Corvia Medical, East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Fire1, Impulse Dynamics, Javelin, Keystone Heart, LuxCath, Manual Surgical Sciences, Medlumics, Medtronic, Middlepeak, Newpace, Nuvera, Philips, Stimda, Surecor, Thermedical, Valcare, and Vizara; and has equity in Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Autonomix, Baclbeat, BioSig, Circa Scientific, Corvia Medical, East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo Farapulse, Fire 1, Javelin, Keystone Heart, LuxCath, Manual Surgical Sciences, Medlumics, Middlepeak, Newpace, Nuvera, Surecor, Valcare, and Vizara. Dr. Ellenbogen serves as a consultant for Biosense Webster, Inc., Medtronic, Boston Scientific, and Abbott; and has received honorarium from Biosense Webster, Medtronic, Boston Scientific, and Abbott. Dr. Natale has served as a consultant for Abbott, Biosense Webster, Inc., Biotronik, Boston Scientific, Baylis, and Medtronic. Dr. Gentlesk has reported that he has no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2020 The Authors
PY - 2020/8
Y1 - 2020/8
N2 - Objectives: This study sought to evaluate the safety and effectiveness of catheter ablation of persistent atrial fibrillation (PsAF) using a porous tip contact force–sensing catheter. Background: Although the safety and effectiveness of catheter ablation of paroxysmal atrial fibrillation are established, there are limited data on outcomes in patients with PsAF. As such, no ablation catheter is currently approved by the Food and Drug Administration for PsAF ablation. Methods: The prospective, multicenter, nonrandomized PRECEPT (Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic PersistenT AF) study was conducted at 27 sites in the United States and Canada. Enrollment criteria included documented symptomatic PsAF and nonresponse or intolerance to ≥1 antiarrhythmic drug (Class I or III). An individualized treatment approach was used including pulmonary vein isolation with ablation of additional targets permitted at the investigators’ discretion. To optimize treatment outcomes, a 3-month post-ablation medication adjustment period followed by a 3-month therapy consolidation period were included. Arrhythmia recurrences were stringently monitored by monthly and symptomatic transtelephonic monitoring, electrocardiography, and Holter monitoring for up to 15 months after ablation. Results: Of 381 enrolled participants, 348 had the investigational catheter inserted and underwent ablation. The primary adverse event rate was 4.1% (15 events in 14 participants). Kaplan-Meier analyses estimated a primary effectiveness success rate of 61.7% and a clinical success rate of 80.4% at 15 months. Conclusions: The results demonstrate the clinical safety and effectiveness of PsAF ablation using contact force–sensing technologies. The primary adverse event was within the expected range and similar to those reported in historical studies of paroxysmal AF ablation. (Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic PersistenT AF; NCT02817776)
AB - Objectives: This study sought to evaluate the safety and effectiveness of catheter ablation of persistent atrial fibrillation (PsAF) using a porous tip contact force–sensing catheter. Background: Although the safety and effectiveness of catheter ablation of paroxysmal atrial fibrillation are established, there are limited data on outcomes in patients with PsAF. As such, no ablation catheter is currently approved by the Food and Drug Administration for PsAF ablation. Methods: The prospective, multicenter, nonrandomized PRECEPT (Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic PersistenT AF) study was conducted at 27 sites in the United States and Canada. Enrollment criteria included documented symptomatic PsAF and nonresponse or intolerance to ≥1 antiarrhythmic drug (Class I or III). An individualized treatment approach was used including pulmonary vein isolation with ablation of additional targets permitted at the investigators’ discretion. To optimize treatment outcomes, a 3-month post-ablation medication adjustment period followed by a 3-month therapy consolidation period were included. Arrhythmia recurrences were stringently monitored by monthly and symptomatic transtelephonic monitoring, electrocardiography, and Holter monitoring for up to 15 months after ablation. Results: Of 381 enrolled participants, 348 had the investigational catheter inserted and underwent ablation. The primary adverse event rate was 4.1% (15 events in 14 participants). Kaplan-Meier analyses estimated a primary effectiveness success rate of 61.7% and a clinical success rate of 80.4% at 15 months. Conclusions: The results demonstrate the clinical safety and effectiveness of PsAF ablation using contact force–sensing technologies. The primary adverse event was within the expected range and similar to those reported in historical studies of paroxysmal AF ablation. (Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic PersistenT AF; NCT02817776)
KW - atrial arrhythmia
KW - porous tip catheter
KW - pulmonary vein isolation
KW - symptomatic atrial fibrillation
KW - transtelephonic monitoring
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UR - http://www.scopus.com/inward/citedby.url?scp=85089229898&partnerID=8YFLogxK
U2 - 10.1016/j.jacep.2020.04.024
DO - 10.1016/j.jacep.2020.04.024
M3 - Article
C2 - 32819531
AN - SCOPUS:85089229898
SN - 2405-500X
VL - 6
SP - 958
EP - 969
JO - JACC: Clinical Electrophysiology
JF - JACC: Clinical Electrophysiology
IS - 8
ER -