Complex fractionated atrial electrogram ablation (LA, right atrial, and coronary sinus) was performed only if normal sinus rhythm was not spontaneously restored after ablation of PV and non-PV triggers and substrate modification with linear ablation. Ablation of spontaneous non-PV triggers or those induced by adenosine or isoproterenol were at the operator’s discretion. A right atrial cavotricuspid isthmus linear ablation was required in cases with documented typical atrial flutter either before or during the procedure. Linear ablation lines were only required to treat documented macro–re-entry atrial tachycardias (ATs) and limited to the LA roof line, mitral valve isthmus line, LA floor line, and cavotricuspid isthmus. Ablation was performed with the STSF catheter guided by the VISITAG module using the following recommended settings: location stability of 3 mm, a minimum time of 3 s, and a force-over-time filter ≤50%. An independent safety monitoring committee reviewed and adjudicated all adverse events.Īfter transseptal puncture, electroanatomic mapping was performed using the CARTO 3 System with either the LASSO Catheter or the PENTARAY NAV Catheter (Biosense Webster, Inc.). All recordings were independently adjudicated by a core laboratory for consistency in interpretation. Twenty-four–hour Holter monitoring was performed at baseline and the 6-, 12-, and 15-month visits, and transtelephonic monitoring (TTM) transmissions were performed monthly or when symptoms occurred during the 9-month evaluation period. Electrocardiograms were obtained at baseline, discharge, and the 6-, 9-, 12-, and 15-month visits. Arrhythmia recurrences were stringently monitored. Participants were followed up at 1, 3, 6, 9, 12, and 15 months after ablation.
Cardioversion was allowed if the arrhythmia recurrence persisted during the therapy consolidation period. During the subsequent therapy consolidation period, the status of the medication adjustment was assessed, and repeat ablation was performed as necessary. Dose modification of the currently used AAD, the addition of a new AAD, and substrate remodeling might occur during the medication adjustment period. As accepted in the most recent consensus statement ( 1), a 3-month medication adjustment period and a 3-month therapy consolidation period (i.e., blanking period) were included after ablation. The study design is summarized in Figure 1. The ablation catheter has been described in detail elsewhere ( 7, 8). This prospective, multicenter, nonrandomized clinical study was designed to evaluate the safety and effectiveness of the STSF catheter in the treatment of drug-refractory symptomatic PsAF compared with predetermined performance goals. investigational device exemption (IDE) clinical study designed to evaluate the safety and effectiveness of catheter ablation in patients with PsAF using the THERMOCOOL SMARTTOUCH SF (STSF) catheter (Biosense Webster, Inc., Irvine, California) porous tip CF catheter ( Central Illustration). The PRECEPT (Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic PersistenT AF) study ( NCT02817776) is the first prospective, multicenter U.S. To date, there is no ablation catheter approved by the Food and Drug Administration for PsAF. Although approximately one-third of AF catheter ablation procedures worldwide are currently performed for persistent or long-standing persistent AF, there are currently limited data on the outcomes of AF ablation in patients with nonparoxysmal AF ( 1, 5).
The increased AF burden resulting from PsAF is associated with a higher risk of stroke, heart failure, and mortality compared with paroxysmal AF ( 6). In a significant portion of patients, paroxysmal AF progresses to more chronic forms of arrhythmia, including persistent atrial fibrillation (PsAF), defined as AF that continues beyond 7 days ( 5). The superiority of catheter ablation of drug-resistant paroxysmal AF in comparison to antiarrhythmic drug (AAD) therapy has been well established, with continued improvements in success rates demonstrated over the past decade with advancement in ablation technologies, especially after the introduction of contact force (CF)–sensing catheters ( 1–4). Radiofrequency (RF) catheter ablation therapy, with the aim of achieving electrical isolation of the pulmonary veins (PVs), is the cornerstone of treatment for atrial fibrillation (AF) ( 1).
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