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Recently, one article about the clinical application of the FireMagic™ TrueForce™ Ablation Catheter (referred to as "TrueForce™ Ablation Catheter") from Shanghai MicroPort EP MedTech Co., Ltd. (referred to as “MicroPort EP”) was published in the journal of Pacing and Clinical Electrophysiology (PACE). The article was entitled “Catheter ablation of atrial fibrillation using FireMagic TrueForce ablation catheter: The TRUEFORCE trial”. In this article, a total of 120 cases clinical applications of the TrueForce™ Ablation Catheter were collected which had been completed together by a number of electrophysiologists from five top three hospitals in China.
The PACE journal, founded in 1978, is one of the foremost peer-reviewed journals in the field of cardiac pacing and clinical electrophysiology. It issued articles on a monthly basis and the total articles issued up to now account for more than 50% of all English articles in the field. The journal focuses on laboratories, clinical cardiac pacing and electrophysiology, and electrostimulation of other organs affecting the cardiovascular system. The article types mainly focus on original articles, literature reviews, teaching articles, and case reports, but also include narrative reviews, book reviews, humanistic reflections, electrophysiologic grand ward-rounds, and device grand ward-rounds.
Research Background: The use of contact force (CF) sensing catheters has provided a revolutionary improvement in catheter ablation (CA) of atrial fibrillation (AF) in the past decade. However, the success rate of CA for AF remains limited, and some complications still occur.
Research Methods: The TRUEFORCE trial (Catheter Ablation of Atrial Fibrillation using FireMagic™ TrueForce™ Ablation Catheter) is a multicenter, prospective, single-arm objective performance criteria study of AF patients who underwent their first CA procedure using FireMagic™ TrueForce™ ablation catheter.
Research Results: A total of 120 patients (118 with paroxysmal AF) were included in this study, and 112 patients included in the per-protocol analysis. Pulmonary vein isolation (PVI) was achieved in 100% of the patients, with procedure and fluoroscopy time of 146.63 ± 40.51 min and 12.89 ± 5.59 min, respectively. Freedom from recurrent atrial arrhythmia after ablation was present 81.25% (95% confidence interval [CI]: 72.78%–88.00%) of patients. No severe adverse events (death, stroke/transient ischemic attack [TIA], esophageal fistula, myocardial infarction, thromboembolism, or pulmonary vein stenosis) were detected during the follow-up. Four (4/115, 3.33%) adverse events were documented, including one abdominal discomfort, one femoral artery hematoma, one coughing up blood, and one postoperative palpitation and insomnia.
Research Conclusions: This study demonstrated the clinical feasibility of FireMagic™ forcesensing ablation catheter in CA of AF, with a satisfactory short- and long-term efficacy and safety.
