Catheter ablation of atrial fibrillation using FireMagic TrueForce ablation catheter: The TRUEFORCE trial.
atrial fibrillation
catheter ablation
contact force
Journal
Pacing and clinical electrophysiology : PACE
ISSN: 1540-8159
Titre abrégé: Pacing Clin Electrophysiol
Pays: United States
ID NLM: 7803944
Informations de publication
Date de publication:
08 2023
08 2023
Historique:
revised:
10
05
2023
received:
18
03
2023
accepted:
29
05
2023
medline:
14
8
2023
pubmed:
19
6
2023
entrez:
19
6
2023
Statut:
ppublish
Résumé
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. 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. 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. 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.
Sections du résumé
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.
Types de publication
Multicenter Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
986-993Informations de copyright
© 2023 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.
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