title: Randomized, Controlled Trial of the Safety and Effectiveness of a Contact Force-Sensing Irrigated Catheter for Ablation of Paroxysmal Atrial Fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study.
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.
  
  
  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.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT01278953.
authors.affiliation: 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.
authors.forename: Vivek Y
authors.initials: VY
authors.lastname: Reddy
authors.affiliation: 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.).
authors.forename: Srinivas R
authors.initials: SR
authors.lastname: Dukkipati
authors.affiliation: 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.).
authors.forename: Petr
authors.initials: P
authors.lastname: Neuzil
authors.affiliation: 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.).
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
authors.affiliation: 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.).
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Albenque
authors.affiliation: 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.).
authors.forename: Josef
authors.initials: J
authors.lastname: Kautzner
authors.affiliation: 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.).
authors.forename: Dipen
authors.initials: D
authors.lastname: Shah
authors.affiliation: 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.).
authors.forename: Gregory
authors.initials: G
authors.lastname: Michaud
authors.affiliation: 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.).
authors.forename: Marcus
authors.initials: M
authors.lastname: Wharton
authors.affiliation: 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.).
authors.forename: David
authors.initials: D
authors.lastname: Harari
authors.affiliation: 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.).
authors.forename: Srijoy
authors.initials: S
authors.lastname: Mahapatra
authors.affiliation: 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.).
authors.forename: Hendrik
authors.initials: H
authors.lastname: Lambert
authors.affiliation: 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.).
authors.forename: Moussa
authors.initials: M
authors.lastname: Mansour
mesh_terms: D000368:Aged; D001145:Arrhythmias, Cardiac / Q000175:diagnosis / Q000209:etiology; D001281:Atrial Fibrillation / Q000175:diagnosis* / Q000601:surgery*; D053840:Brugada Syndrome; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods*; D000075224:Cardiac Conduction System Disease; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006329:Heart Conduction System / Q000002:abnormalities; D006801:Humans; D008297:Male; D008875:Middle Aged; D010493:Pericarditis / Q000175:diagnosis / Q000209:etiology; D011446:Prospective Studies; D016896:Treatment Outcome
keywords: ablation techniques; atrial fibrillation; catheter ablation