ArticleHeart rhythm O22023
Safety and effectiveness of the first contact force ablation catheter with a flexible tip.
Article in Heart rhythm O2, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
3 citing papers in PubMed, 4 citations in OpenAlex.
- Averaged Impedance Drop Estimates Conduction Gap During Pulmonary Vein Isolation in Atrial Fibrillation.Journal of cardiovascular electrophysiology · 2026Article
- Controversy: pulsed field ablation is the standard technique for all the candidates for atrial fibrillation ablation.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Review
- Feasibility and efficacy of 50 W ablation with the TactiFlex catheter for the initial pulmonary vein isolation of atrial fibrillation.Journal of arrhythmia · 2025Article
Corrections and comments
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Authors and funding
13 authors at 12 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Catheter ablation is an established therapy for paroxysmal atrial fibrillation (PAF). The TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) is a next-generation radiofrequency ablation catheter incorporating fiber optics-based contact force-sensing technology with a flexible, laser-cut tip. Objective: The study sought to evaluate the safety and effectiveness of the TactiFlex SE ablation catheter for treatment of drug-refractory PAF. Methods: The TactiFlex AF investigational device exemption was a prospective, nonrandomized, multicenter clinical study. Enrollment began on June 26, 2020 and completed June 18, 2021. Subjects with PAF underwent de novo pulmonary vein isolation and, if indicated, ablation for typical atrial flutter. Subjects were followed for 12 months. Results: Of the 355 subjects enrolled at 37 sites worldwide, 334 underwent ablation with the TactiFlex SE catheter. The Kaplan-Meier estimate of 12-month freedom from AF/atrial flutter (AFL)/atrial tachycardia recurrence was 72.9% (95% confidence interval [CI] 95% CI 67.2%-77.8%) and clinical success was 83.6% (95% CI 95% CI 78.1%-87.2%). As-treated analyses compared subjects treated at high power (left atrium time-averaged power setting 40-50 W; n = 222) vs low power (<40 W; n = 97). The Kaplan-Meier estimate of 12-month freedom from AF/AFL/atrial tachycardia recurrence was 76.4% (95% CI 69.3%-82.0%) and clinical success was 83.9% (95% CI 77.5%-88.6%) in the high-power group compared with 66.8% (95% CI 56.1%-75.5%) and 80.7% (95% CI 70.8%- 87.5%), respectively, in the low-power group. The primary safety event rate in all treated subjects was 4.3%; 4.1% in the HP group and 5.2% in the LP group ( Conclusion: TactiFlex SE is safe and effective for treatment of drug-refractory PAF and concomitant AFL and enables more efficient procedures than previous generation catheters.
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