Catheter ablation of atrial fibrillation using FireMagic TrueForce ablation catheter: The TRUEFORCE trial.

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.

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.

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.

CONCLUSIONS

This study demonstrated the clinical feasibility of FireMagic force-sensing ablation catheter in CA of AF, with a satisfactory short- and long-term efficacy and safety.