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

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 tre...

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Veröffentlicht in:	Circulation (New York, N.Y.) Jg. 132; H. 10; S. 907
Hauptverfasser:	Reddy, Vivek Y, Dukkipati, Srinivas R, Neuzil, Petr, Natale, Andrea, Albenque, Jean-Paul, Kautzner, Josef, Shah, Dipen, Michaud, Gregory, Wharton, Marcus, Harari, David, Mahapatra, Srijoy, Lambert, Hendrik, Mansour, Moussa
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States 08.09.2015
Schlagworte:	Aged Arrhythmias, Cardiac - diagnosis Arrhythmias, Cardiac - etiology Atrial Fibrillation - diagnosis Atrial Fibrillation - surgery Brugada Syndrome Cardiac Catheterization - adverse effects Cardiac Catheterization - methods Cardiac Conduction System Disease Catheter Ablation - adverse effects Catheter Ablation - methods Female Follow-Up Studies Heart Conduction System - abnormalities Humans Male Middle Aged Pericarditis - diagnosis Pericarditis - etiology Prospective Studies Treatment Outcome atrial fibrillation catheter ablation ablation techniques
ISSN:	1524-4539, 1524-4539
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Abstract	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. 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). The CF ablation catheter met the primary safety and effectiveness end points. Additionally, optimal CF was associated with improved effectiveness. http://www.clinicaltrials.gov. Unique identifier: NCT01278953.
AbstractList	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.BACKGROUNDContact 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.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).METHODS AND RESULTSA 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).The CF ablation catheter met the primary safety and effectiveness end points. Additionally, optimal CF was associated with improved effectiveness.CONCLUSIONSThe CF ablation catheter met the primary safety and effectiveness end points. Additionally, optimal CF was associated with improved effectiveness.http://www.clinicaltrials.gov. Unique identifier: NCT01278953.CLINICAL TRIAL REGISTRATIONhttp://www.clinicaltrials.gov. Unique identifier: NCT01278953. 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. 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). The CF ablation catheter met the primary safety and effectiveness end points. Additionally, optimal CF was associated with improved effectiveness. http://www.clinicaltrials.gov. Unique identifier: NCT01278953.
Author	Reddy, Vivek Y Harari, David Neuzil, Petr Shah, Dipen Mahapatra, Srijoy Michaud, Gregory Albenque, Jean-Paul Lambert, Hendrik Wharton, Marcus Dukkipati, Srinivas R Natale, Andrea Mansour, Moussa Kautzner, Josef
Author_xml	– sequence: 1 givenname: Vivek Y surname: Reddy fullname: Reddy, Vivek Y email: Vivek.Reddy@mountsinai.org organization: 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 – sequence: 2 givenname: Srinivas R surname: Dukkipati fullname: Dukkipati, Srinivas R organization: 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.) – sequence: 3 givenname: Petr surname: Neuzil fullname: Neuzil, Petr organization: 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.) – sequence: 4 givenname: Andrea surname: Natale fullname: Natale, Andrea organization: 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.) – sequence: 5 givenname: Jean-Paul surname: Albenque fullname: Albenque, Jean-Paul organization: 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.) – sequence: 6 givenname: Josef surname: Kautzner fullname: Kautzner, Josef organization: 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.) – sequence: 7 givenname: Dipen surname: Shah fullname: Shah, Dipen organization: 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.) – sequence: 8 givenname: Gregory surname: Michaud fullname: Michaud, Gregory organization: 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.) – sequence: 9 givenname: Marcus surname: Wharton fullname: Wharton, Marcus organization: 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.) – sequence: 10 givenname: David surname: Harari fullname: Harari, David organization: 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.) – sequence: 11 givenname: Srijoy surname: Mahapatra fullname: Mahapatra, Srijoy organization: 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.) – sequence: 12 givenname: Hendrik surname: Lambert fullname: Lambert, Hendrik organization: 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.) – sequence: 13 givenname: Moussa surname: Mansour fullname: Mansour, Moussa organization: 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.)
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/26260733$$D View this record in MEDLINE/PubMed
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Snippet	Contact force (CF) is a major determinant of lesion size and transmurality and has the potential to improve efficacy of atrial fibrillation ablation. This...
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SubjectTerms	Aged Arrhythmias, Cardiac - diagnosis Arrhythmias, Cardiac - etiology Atrial Fibrillation - diagnosis Atrial Fibrillation - surgery Brugada Syndrome Cardiac Catheterization - adverse effects Cardiac Catheterization - methods Cardiac Conduction System Disease Catheter Ablation - adverse effects Catheter Ablation - methods Female Follow-Up Studies Heart Conduction System - abnormalities Humans Male Middle Aged Pericarditis - diagnosis Pericarditis - etiology Prospective Studies Treatment Outcome
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
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