Safety and Effectiveness of the First Contact Force Ablation Catheter With a Flexible Tip

Authors

• Devi Nair
• Martin Martinek
• B Judson Colley
• Sri Sundaram
• Ramesh Hariharan
• Gustavo Morales
• Philipp Sommer
• Stewart Healy
• Usman Siddiqui
• Douglas Gibson
• Kristina Chapman
• Anne Sarver
• Monica Lo

Language

English

Publication Date

12-1-2023

Journal

Heart Rhythm O2

DOI

10.1016/j.hroo.2023.10.006

PMID

38204461

PMCID

PMC10774658

PubMedCentral® Posted Date

10-31-2023

PubMedCentral® Full Text Version

Post-print

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 (P = .7671).

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.

Keywords

Atrial fibrillation, Atrial flutter, Radiofrequency catheter ablation, Clinical trial, Contact force

Published Open-Access

yes

Recommended Citation

Nair, Devi; Martinek, Martin; Colley, B Judson; et al., "Safety and Effectiveness of the First Contact Force Ablation Catheter With a Flexible Tip" (2023). Faculty, Staff and Student Publications. 3595.
https://digitalcommons.library.tmc.edu/uthmed_docs/3595