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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
VY. Reddy, SR. Dukkipati, P. Neuzil, A. Natale, JP. Albenque, J. Kautzner, D. Shah, G. Michaud, M. Wharton, D. Harari, S. Mahapatra, H. Lambert, M. Mansour,
Circulation (New York, N.Y.).
2015 ;
132 (10) :
907-15.
[pub] 20150810
Language English Country United States
Document type Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
Persistent link
https://www.medvik.cz/link/bmc16000063
Online
Full text
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from 1950 to 1 year ago
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- MeSH
- Atrial Fibrillation diagnosis surgery MeSH
- Catheter Ablation adverse effects methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Pericarditis diagnosis etiology MeSH
- Heart Conduction System abnormalities MeSH
- Prospective Studies MeSH
- Aged MeSH
- Arrhythmias, Cardiac diagnosis etiology MeSH
- Cardiac Catheterization adverse effects methods MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
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.
Brigham and Women's Hospital Boston MA
Clinique Pasteur Toulouse France
From Icahn School of Medicine at Mount Sinai New York NY
Homolka Hospital Prague Czech Republic
Institute for Clinical and Experimental Medicine IKEM Prague Czech Republic
Massachusetts General Hospital Boston
Medical University of South Carolina Charleston
St Jude Medical Inc St Paul MN
References provided by Crossref.org
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- $a Reddy, Vivek Y $u 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.
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- $a 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.
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