Safety and Effectiveness of a Next-Generation Contact Force Catheter: Results of the TactiSense Trial.

Abstract

OBJECTIVES\nThe 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).\n\n\nBACKGROUND\nCatheter 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.\n\n\nMETHODS\nThis 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 end point was the rate of device- or procedure-related serious adverse events occurring within 7\xa0days. The primary effectiveness end point was acute success defined as pulmonary vein isolation at 30\xa0min after ablation. Two descriptive end points were prospectively captured: 1) 1-year freedom from recurrence of symptomatic AF, atrial flutter (AFL), and atrial tachycardia (AT) lasting\xa0≥30\xa0s 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\xa0≥30\xa0s without using class I/III antiarrhythmic drugs.\n\n\nRESULTS\nPrimary 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%\xa0CI: 94.95% to 99.46%). According to Kaplan-Meier estimates at 1 year, 82.2% (95%\xa0CI: 74.7% to 87.6%) were free from symptomatic recurrence, and 1-year drug-free success was 68.2% (95%\xa0CI: 59.9% to 75.1%).\n\n\nCONCLUSIONS\nThe TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ is safe and effective for the treatment of paroxysmal\xa0AF.