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Safety and Effectiveness of a Next-Generation Contact Force Catheter: Results of the TactiSense Trial.
Lo, Monica Y; Sanders, Prashanthan; Sommer, Phillipp; Kalman, Jonathan M; Siddiqui, Usman R; Sundaram, Sri; Piorkowski, Christopher; Olson, Nicholas; Madej, Steven M; Gibson, Douglas N.
Afiliación
  • Lo MY; Heart Rhythm Institute, Arkansas Heart Hospital, Little Rock, Arkansas, USA. Electronic address: monica.lo@arheart.com.
  • Sanders P; Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital, Adelaide, South Australia, Australia.
  • Sommer P; Clinic for Electrophysiology, Herz-und Diabeteszentrum NRW, University Hospital of Ruhr-University Bochum, Bad Oeynhausen, Germany.
  • Kalman JM; Department of Cardiology, Royal Melbourne Hospital, Parkville, Victoria, Australia; Department of Medicine, University of Melbourne, Parkville, Victoria, Australia.
  • Siddiqui UR; Cardiology and Cardiac Electrophysiology, Advent Health Orlando, Orlando, Florida, USA.
  • Sundaram S; Cardiac Electrophysiology Department, South Denver Cardiology Associates, Denver, Colorado, USA.
  • Piorkowski C; Electrophysiology and Heart Failure Division, Abbott, Plymouth, Minnesota, USA.
  • Olson N; Cardiac Electrophysiology, Scripps Clinic and Prebys Cardiovascular Institute, La Jolla, California, USA.
  • Madej SM; Electrophysiology and Heart Failure Division, Abbott, Plymouth, Minnesota, USA.
  • Gibson DN; Cardiac Electrophysiology, Scripps Clinic and Prebys Cardiovascular Institute, La Jolla, California, USA.
JACC Clin Electrophysiol ; 7(8): 1013-1021, 2021 08.
Article en En | MEDLINE | ID: mdl-33812831
OBJECTIVES: The objective of this clinical trial was to evaluate the safety and effectiveness of the TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) (Abbott, Abbott Park, Illinois) for the treatment of drug-refractory, symptomatic paroxysmal atrial fibrillation (PAF). BACKGROUND: Catheter ablation of atrial fibrillation (AF) is an established therapy for the treatment of PAF. Ablation technology is evolving with the primary goals of improving efficacy and safety of the procedure. METHODS: This was a multicenter single-arm trial evaluating a novel ablation catheter for the treatment of PAF. A total of 156 subjects were enrolled at 19 sites in the United States, Europe, and Australia. The primary safety endpoint was the rate of device- or procedure-related serious adverse events occurring within 7 days. The primary effectiveness endpoint was acute success defined as pulmonary vein isolation at 30 min after ablation. Two descriptive endpoints were prospectively captured: 1) 1-year freedom from recurrence of symptomatic AF, atrial flutter (AFL), and atrial tachycardia (AT) lasting ≥30 s without a new or increased dose of Class I/III antiarrhythmic drugs; and 2) 1-year drug-free success defined by the absence of any recurrent AF/AFL/AT lasting ≥30 s without using Class I/III antiarrhythmic drugs. RESULTS: Primary safety events occurred in 4.7% of patients (95% confidence interval [CI]: 2.23% to 8.64%), and the procedure was acutely successful in 98.0% of patients (95% CI: 94.95% to 99.46%). According to Kaplan-Meier estimates at 1 year, 82.2% (95% CI: 74.7% to 87.6%) were free from symptomatic recurrence, and 1-year drug-free success was 68.2% (95% CI: 59.9% to 75.1%). CONCLUSIONS: The TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ is safe and effective for the treatment of paroxysmal AF.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Venas Pulmonares / Fibrilación Atrial / Ablación por Catéter Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: JACC Clin Electrophysiol Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Venas Pulmonares / Fibrilación Atrial / Ablación por Catéter Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: JACC Clin Electrophysiol Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos