Vivek Y Reddy1, Srinivas R Dukkipati2, Petr Neuzil2, Andrea Natale2, Jean-Paul Albenque2, Josef Kautzner2, Dipen Shah2, Gregory Michaud2, Marcus Wharton2, David Harari2, Srijoy Mahapatra2, Hendrik Lambert2, Moussa Mansour2. 1. From Icahn School of Medicine at Mount Sinai, New York, NY (V.Y.R., S.R.D.); Homolka Hospital, Prague, Czech Republic (P.N.); Texas Cardiac Arrhythmia Institute, Austin (A.N.); Clinique Pasteur, Toulouse, France (J.-P.A.); Institute for Clinical and Experimental Medicine-IKEM, Prague, Czech Republic (J.K.); University Hospitals of Geneva, Switzerland (D.S.); Brigham and Women's Hospital, Boston, MA (G.M.); Medical University of South Carolina, Charleston (M.W.); St. Jude Medical Inc, St. Paul, MN (D.H., S.M., H.L.); and Massachusetts General Hospital, Boston (M.M.). Vivek.Reddy@mountsinai.org. 2. From Icahn School of Medicine at Mount Sinai, New York, NY (V.Y.R., S.R.D.); Homolka Hospital, Prague, Czech Republic (P.N.); Texas Cardiac Arrhythmia Institute, Austin (A.N.); Clinique Pasteur, Toulouse, France (J.-P.A.); Institute for Clinical and Experimental Medicine-IKEM, Prague, Czech Republic (J.K.); University Hospitals of Geneva, Switzerland (D.S.); Brigham and Women's Hospital, Boston, MA (G.M.); Medical University of South Carolina, Charleston (M.W.); St. Jude Medical Inc, St. Paul, MN (D.H., S.M., H.L.); and Massachusetts General Hospital, Boston (M.M.).
Abstract
BACKGROUND:Contact force (CF) is a major determinant of lesion size and transmurality and has the potential to improve efficacy of atrial fibrillation ablation. This study sought to evaluate the safety and effectiveness of a novel irrigated radiofrequency ablation catheter that measures real-time CF in the treatment of patients with paroxysmal atrial fibrillation. METHODS AND RESULTS: A total of 300 patients with symptomatic, drug-refractory, paroxysmal atrial fibrillation were enrolled in a prospective, multicenter, randomized, controlled trial and randomized to radiofrequency ablation with either a novel CF-sensing catheter or a non-CF catheter (control). The primary effectiveness end point consisted of acute electrical isolation of all pulmonary veins and freedom from recurrent symptomatic atrial arrhythmia off all antiarrhythmic drugs at 12 months. The primary safety end point included device-related serious adverse events. End points were powered to show noninferiority. All pulmonary veins were isolated in both groups. Effectiveness was achieved in 67.8% and 69.4% of subjects in the CF and control arms, respectively (absolute difference, -1.6%; lower limit of 1-sided 95% confidence interval, -10.7%; P=0.0073 for noninferiority). When the CF arm was stratified into optimal CF (≥90% ablations with ≥10 g) and nonoptimal CF groups, effectiveness was achieved in 75.9% versus 58.1%, respectively (P=0.018). The primary safety end point occurred in 1.97% and 1.40% of CF patients and control subjects, respectively (absolute difference, 0.57%; upper limit of 1-sided 95% confidence interval, 3.61%; P=0.0004 for noninferiority). CONCLUSIONS: The CF ablation catheter met the primary safety and effectiveness end points. Additionally, optimal CF was associated with improved effectiveness. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT01278953.
RCT Entities:
BACKGROUND: Contact force (CF) is a major determinant of lesion size and transmurality and has the potential to improve efficacy of atrial fibrillation ablation. This study sought to evaluate the safety and effectiveness of a novel irrigated radiofrequency ablation catheter that measures real-time CF in the treatment of patients with paroxysmal atrial fibrillation. METHODS AND RESULTS: A total of 300 patients with symptomatic, drug-refractory, paroxysmal atrial fibrillation were enrolled in a prospective, multicenter, randomized, controlled trial and randomized to radiofrequency ablation with either a novel CF-sensing catheter or a non-CF catheter (control). The primary effectiveness end point consisted of acute electrical isolation of all pulmonary veins and freedom from recurrent symptomatic atrial arrhythmia off all antiarrhythmic drugs at 12 months. The primary safety end point included device-related serious adverse events. End points were powered to show noninferiority. All pulmonary veins were isolated in both groups. Effectiveness was achieved in 67.8% and 69.4% of subjects in the CF and control arms, respectively (absolute difference, -1.6%; lower limit of 1-sided 95% confidence interval, -10.7%; P=0.0073 for noninferiority). When the CF arm was stratified into optimal CF (≥90% ablations with ≥10 g) and nonoptimal CF groups, effectiveness was achieved in 75.9% versus 58.1%, respectively (P=0.018). The primary safety end point occurred in 1.97% and 1.40% of CF patients and control subjects, respectively (absolute difference, 0.57%; upper limit of 1-sided 95% confidence interval, 3.61%; P=0.0004 for noninferiority). CONCLUSIONS: The CF ablation catheter met the primary safety and effectiveness end points. Additionally, optimal CF was associated with improved effectiveness. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT01278953.
Authors: Alexander C Perino; George C Leef; Andrew Cluckey; Fahd N Yunus; Mariam Askari; Paul A Heidenreich; Sanjiv M Narayan; Paul J Wang; Mintu P Turakhia Journal: Am Heart J Date: 2018-10-29 Impact factor: 4.749
Authors: Bhradeev Sivasambu; Joe B Hakim; Viachaslau Barodka; Jonathan Chrispin; Ronald D Berger; Hiroshi Ashikaga; Luisa Ciuffo; Susumu Tao; Hugh Calkins; Joseph E Marine; Natalia Trayanova; David D Spragg Journal: JACC Clin Electrophysiol Date: 2018-11-01
Authors: Hugh Calkins; Gerhard Hindricks; Riccardo Cappato; Young-Hoon Kim; Eduardo B Saad; Luis Aguinaga; Joseph G Akar; Vinay Badhwar; Josep Brugada; John Camm; Peng-Sheng Chen; Shih-Ann Chen; Mina K Chung; Jens Cosedis Nielsen; Anne B Curtis; D Wyn Davies; John D Day; André d'Avila; N M S Natasja de Groot; Luigi Di Biase; Mattias Duytschaever; James R Edgerton; Kenneth A Ellenbogen; Patrick T Ellinor; Sabine Ernst; Guilherme Fenelon; Edward P Gerstenfeld; David E Haines; Michel Haissaguerre; Robert H Helm; Elaine Hylek; Warren M Jackman; Jose Jalife; Jonathan M Kalman; Josef Kautzner; Hans Kottkamp; Karl Heinz Kuck; Koichiro Kumagai; Richard Lee; Thorsten Lewalter; Bruce D Lindsay; Laurent Macle; Moussa Mansour; Francis E Marchlinski; Gregory F Michaud; Hiroshi Nakagawa; Andrea Natale; Stanley Nattel; Ken Okumura; Douglas Packer; Evgeny Pokushalov; Matthew R Reynolds; Prashanthan Sanders; Mauricio Scanavacca; Richard Schilling; Claudio Tondo; Hsuan-Ming Tsao; Atul Verma; David J Wilber; Teiichi Yamane Journal: Heart Rhythm Date: 2017-05-12 Impact factor: 6.343