This was a non-randomized cohort study based on a retrospective analysis of patient-level data that was prospectively collected for ablation patients enrolled in the REAL AF Registry [13 (link)]. The registry enrolls consecutive adults (≥ 18 years) ablated with a contact force (CF) catheter at a participating site, excluding any patients enrolled in a clinical trial that would prescribe any aspect of their treatment.
The study population included patients having de novo PAF ablation performed by one of three operators at a single high-volume site between January 2018 and May 2019. Cohorts of interest were defined by procedures that utilized a Vizigo sheath (Vizigo cohort) versus those that did not (non-Vizigo cohort). All patients underwent their first left atrial ablation with the THERMOCOOL SMARTTOUCH® SF Catheter (STSF; Biosense Webster, Inc., Irvine, CA) and were evaluated according to standard clinical practices at the study site. Approval was obtained from the WCG Institutional Review Board.
The study population included patients having de novo PAF ablation performed by one of three operators at a single high-volume site between January 2018 and May 2019. Cohorts of interest were defined by procedures that utilized a Vizigo sheath (Vizigo cohort) versus those that did not (non-Vizigo cohort). All patients underwent their first left atrial ablation with the THERMOCOOL SMARTTOUCH® SF Catheter (STSF; Biosense Webster, Inc., Irvine, CA) and were evaluated according to standard clinical practices at the study site. Approval was obtained from the WCG Institutional Review Board.
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