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BACKGROUND: Recurrence during the 3-month blanking period following radiofrequency ablation of atrial fibrillation (AF) is typically not considered as a predictor for late recurrence. OBJECTIVE: We investigated the significance of early recurrence as a risk factor for late recurrence in AF patients receiving pulsed-field ablation (PFA). METHODS: Consecutive patients undergoing PFA were prospectively followed-up for 1 year. All patients received isolation of pulmonary veins. Additional ablations were performed per operator's discretion. Following the procedure all remained on their previously ineffective antiarrhythmic drugs (AAD) during the 2-month blanking period after which the AADs were discontinued. Early recurrence was defined as atrial arrhythmia of > 30 second duration during the 3-mo blanking period and any recurrence beyond 3-mo was considered as late recurrence. RESULTS: A total of 337 patients undergoing PFA for AF were included. Early recurrence was recorded in 53 (15.7%) patients; 10 in the 1st month, 12 in the 2nd month and 31 in the 3rd month. Of the 10 patients having recurrence during the 1st month, 7 (70%) remained in sinus rhythm after cardioversion whereas 3 (30%) underwent redo because of late-recurrence. At 1 year, all patients with recurrence during the 2nd and 3rd month, experienced late-recurrence of which 10/12 and 27/31 underwent redo and the remaining 6 patients were in sinus on-AAD. CONCLUSION: In this consecutive series of AF patients, early-recurrence in the 2nd or 3rd month following the PFA procedure was associated with high risk of late-recurrence. Thus, blanking period could be redefined as 1-month following PFA.
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BACKGROUND: Despite their improved safety, majority of cardiac electrophysiology procedures, including catheter ablation (CA), are presently performed in hospital outpatient departments (HODs). OBJECTIVE: This large, multicenter study investigated the safety and outcomes associated with various cardiac electrophysiology procedures performed at 6 ambulatory surgery centers (ASCs), primarily during the COVID-19 pandemic under the CMS Hospitals Without Walls program. METHODS: We retrospectively analyzed the outcomes from consecutive electrophysiology procedures performed in ASCs with same-day discharge, including transesophageal echocardiography (TEE), cardioversion, cardiac implantable electronic device (CIED) implantation, electrophysiology studies (EPS), and CA for atrial fibrillation (AF), atrial flutter (AFL)/supraventricular tachycardia (SVT), ventricular premature complexes (VPCs), and AV node. RESULTS: Altogether, 4,037 procedures were performed, including 779 TEE/cardioversions (19.3%), 1,453 CIED implants (36.0%), 26 EPS (0.6%), and 1,779 CAs (44.1%) for AF (75.4%), AFL/SVT (18.8%), VPC (4.7%), and AV node (1.1%). Overall, 80.2% of CAs were for left-sided atrial arrhythmias (AF/atypical AFL) requiring transseptal catheterization. Left-sided VPC ablations (42.2%) were performed using a transseptal/retrograde approach. Adverse event rates were low, but comparable between CIED and CA (0.76% vs. 0.73%; P=0.93), as were the incidences of urgent/unplanned post-procedure hospitalization (0.48% vs. 0.45%; P=0.89), respectively. Moreover, the adverse event rates in ASCs versus HODs did not differ for CIED (0.76% vs. 0.65%; P=0.71) or CA (0.73% vs. 0.80%; P=0.79). CONCLUSION: The results from this large, multicenter study suggest that ASCs represent a safe and effective setting to conduct a variety of cardiac electrophysiology procedures including CA. These findings bear important implications for healthcare delivery and policy.
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INTRODUCTION: Hemostasis following large-bore femoral vein access remains a challenge. Manual compression has been the standard of care but requires bedside staff, prolonged bed rest, and longer length of stay. The LockeT is an external compression device that attempts to address these issues while achieving venous hemostasis. OBJECTIVES: We evaluate postprocedural hemostasis and vascular closure outcomes after using LockeT following cardiac electrophysiologic procedures. METHODS: We performed a single-center, observational study of patients who underwent vascular closure for electrophysiology procedures using LockeT. Postprocedural outcomes were subsequently analyzed. RESULTS: We studied 102 patients (N) for whom LockeT was used to close 182 separate vascular access sites (n). Common procedures were atrial fibrillation ablation (56.9%, N = 58) and left atrial appendage occlusion (28.4%, N = 29). Most often, 8-Fr [48.3% (n = 126)], 11-Fr [27.2% (n = 71)], and 8.5-Fr [16.9% (n = 44)] sheaths were used, with an average procedure time of 82.1 ± 29.4 min. Hemostasis was achieved in 97.8% (n = 187) of all LockeT cases. Time to ambulation and discharge were 3.93 ± 1.10 h and 8.1 ± 4.4 h, respectively. No major complications were noted. Postprocedurally, 52% (N = 53) of patients were discharged on the same day. There were no differences in hemostasis (p = .859) or ambulation times (p = .202) between procedure types. CONCLUSION: The LockeT can effectively close venous access sites with no major complications.
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BACKGROUND: Pulsed field ablation (PFA) is a novel, myocardial-selective, non-thermal ablation modality used to target cardiac arrhythmias. Although prompt EGM signal disappearance is observed immediately after PFA application in the pulmonary veins, whether this finding results in adequate transmural lesions is unknown. STUDY AIM: If application repetition and catheter-tissue contact impact on lesion formation during PFA. METHODS: A circular loop PFA catheter was used to deliver repeated energy applications with various levels of contact-force. A benchtop vegetal potato model and a beating heart ventricular myocardial model were utilized to evaluate the impact of application repetition, contact force, and catheter repositioning on contiguity and lesion depth. Lesion development occurred over 18 hours in the vegetal model and over 6 hours in the porcine model. RESULTS: Lesion formation was found to be dependent on application repetition and contact. In porcine ventricles, single and multiple stacked applications led to a lesion depth of 3.5 ± 0.7 mm and 4.4 ± 1.3 mm, respectively (p =0.002). Furthermore, the greater the catheter-tissue contact, the more contiguous and deeper the lesions in the vegetal model (1.0±0.9 mm with no contact Vs. 5.4±1.4 mm with 30 g of force; p=.0001). CONCLUSION: PFA delivered via a circular catheter showed that both repetition and catheter contact led independently to deeper lesion formation. These findings indicate that endpoints for effective PFA ablation are more related to PFA biophysics than mere EGM attenuation.
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INTRODUCTION: Patients undergoing left atrial appendage occlusion (LAAO) are at increased risk for bleeding or thromboembolic events. Concurrently, biomarkers are of growing importance in risk stratification for atrial fibrillation patients. We aimed to evaluate the association of hematological markers and clinical characteristics with the occurrence of thromboembolic and bleeding events following LAAO. METHODS: Seven implanting centers retrospectively gathered data on hematological markers (i.e., platelet count [PC], mean platelet volume [MPV], and fibrinogen) prior to LAAO. Prespecified thromboembolic and major bleeding outcomes were collected and the association with pre-procedural hematological markers and clinical characteristics was evaluated using Cox regression analysis. RESULTS: In total, 1,315 patients were included (74 ± 9 years, 36% female, CHA2DS2-VASc 4.3 ± 1.5, HAS-BLED 3.3 ± 1.1). Over a total follow-up duration of 2,682 patient years, 77 thromboembolic events and 107 major bleeding events occurred after LAAO. Baseline PC was the only biomarker showing a signal for a relation to thromboembolic events (HR 1.18, 95% CI: 1.00-1.39) per 50*109 increment, p = 0.056). Thrombotic event rates, including device-related thrombus, increased within higher PC quartiles. Thromboembolism was associated with age (HR 1.05, 95% CI: 1.00-1.10, per year increase) and prior thromboembolism (HR 2.08, 95% CI: 1.07-4.03), but with none of the biomarkers in multivariate analysis. No association of any of the hematological markers with major bleeding was observed. Major bleeding following LAAO was associated with prior major bleeding (HR 5.27, 95% CI: 2.71-10.22), renal disease (HR 1.93, 95% CI: 1.17-3.18), and discharge on dual antiplatelet therapy (DAPT) (HR 1.71, 95% CI: 1.05-2.77). CONCLUSION: Most thrombotic events occurred in the highest PC quartile, but no association of any of the hematological markers with thromboembolism or major bleeding was observed in our analysis. In multivariate analysis, older age and prior thromboembolism were associated with thromboembolism. Prior major bleeding, renal disease and discharge on DAPT were multivariate predictors of major bleeding after LAAO.
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Background: Posterior wall ablation (PWA) is commonly added to pulmonary vein isolation (PVI) during catheter ablation (CA) of persistent atrial fibrillation (AF). Objective: The purpose of this study was to compare PVI plus PWA using very-high-power short-duration (vHPSD) vs standard-power (SP) ablation index-guided CA among consecutive patients with persistent AF and to determine the voltage correlation between microbipolar and bipolar mapping in AF. Methods: We compared 40 patients undergoing PVI plus PWA using vHPSD to 40 controls receiving PVI plus PWA using SP. The primary efficacy endpoint was recurrence of atrial tachyarrhythmias after a 3-month blanking period. The primary safety outcome was a composite of major complications within 30 days after CA. In the vHPSD group, high-density mapping of the posterior wall was performed using both a multipolar catheter and microelectrodes on the tip of the ablation catheter. Results: PVI was more commonly obtained with vHPSD compared to SP ablation (98%vs 75%; P = .007), despite shorter procedural and fluoroscopy times (P <.001). Survival free from recurrent atrial tachyarrhythmias at 18 months was 68% and 47% in the vHPSD and SP groups, respectively (log-rank P = .071), without major adverse events. The vHPSD approach was significantly associated with reduced risk of recurrent AF at multivariable analysis (hazard ratio 0.39; P = .030). Microbipolar voltage cutoffs of 0.71 and 1.69 mV predicted minimum bipolar values of 0.16 and 0.31 mV in AF, respectively, with accuracies of 0.67 and 0.88. Conclusion: vHPSD PWA plus PVI may be faster and as safe as SP CA among patients with persistent AF, with a trend for superior efficacy. Adapted voltage cutoffs should be used for identifying atrial low-voltage areas with microbipolar mapping.
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INTRODUCTION: Four-dimensional (4D) intracardiac echocardiography (ICE) is a novel cardiac imaging modality that has been applied to various workflows, including catheter ablation, tricuspid valve repair, and left atrial appendage occlusion (LAAO). The use of this type of advanced ICE imaging may ultimately allow for the replacement of transesophageal echocardiography (TEE) for LAAO, providing comparable imaging quality while eliminating the need for general anesthesia. METHODS: Based on our initial clinical experience with 4D ICE in LAAO, we have developed an optimized workflow for the use of the NUVISION™ 4D ICE Catheter in conjunction with the GE E95 and S70N Ultrasound Systems in LAAO. In this manuscript, we provide a step-by-step guide to using 4D ICE in conjunction with compatible imaging consoles. We have also evaluated the performance of 4D ICE with the NUVISION Ultrasound Catheter versus TEE in one LAAO case and present those results here. RESULTS: In our comparison of 4D ICE using our optimized workflow with TEE in an LAAO case, ICE LAA measurements were similar to those from TEE. The best image resolution was seen via ICE in 2-dimensional and multislice modes (triplane and biplane). The FlexiSlice multiplanar reconstruction tool, which creates an en-face image derived from a 4D volume set, also provided valuable information but yielded slightly lower image quality, as expected for these volume-derived images. For this case, comparable images were obtained with TEE and ICE but with less need to reposition the ICE catheter. CONCLUSION: The use of optimized 4D ICE catheter workflow recommendations allows for efficient LAAO procedures, with higher resolution imaging, comparable to TEE.
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Apéndice Atrial , Ecocardiografía Tetradimensional , Ecocardiografía Transesofágica , Flujo de Trabajo , Apéndice Atrial/diagnóstico por imagen , Apéndice Atrial/cirugía , Humanos , Fibrilación Atrial/cirugía , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/fisiopatología , Valor Predictivo de las Pruebas , Cateterismo Cardíaco/instrumentación , Ultrasonografía Intervencional , MasculinoRESUMEN
Background: Atrial fibrillation (AF) is the most common arrhythmia reported worldwide. There is significant heterogeneity in AF care pathways for a patient seen in the emergency room, impacting access to guideline-driven therapies. Objectives: The purpose of this study was to compare the difference in AF outcomes between those treated with an organized treatment pathway vs routine-care approach. Methods: The emergency room to electrophysiology service study (ER2EP) is a multicenter, prospective observational registry (NCT04476524) enrolling patients with AF from sites where a pathway for management of AF was put in place compared to sites where a pathway was not in place within the same health system and the same physicians providing services at all sites. Multivariable regression modeling was performed to identify predictors of clinical outcomes. Beta coefficient or odds ratio was reported as appropriate. Results: A total of 500 patients (ER2EP group, n = 250; control group, n = 250) were included in the study. The mean age was 73.4 ± 12.9 years, and 52.2% were males. There was a statistically significant difference in primary endpoint [time to ablation (56 ± 50.9 days vs 183.3 ± 109.5 days; P < 0.001), time to anticoagulation initiation (2.1 ± 1.6 days vs 19.7 ± 35 days, P < 0.001), antiarrhythmic drug initiation (4.8 ± 7.1 days vs 24.7 ± 44.4 days, P < 0.001) compared to the control group, respectively. As such, this resulted in reduced length of stay in the ER2EP group compared to the control group (2.4 ± 1.4 days vs 3.23 ± 2.5 days, P = 0.002). Conclusions: This study provides evidence that having an organized pathway from the emergency department for AF patients involving electrophysiology services can improve early access to definitive therapies and clinical outcomes.
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BACKGROUND: Purkinje fibers play an important role in initiation and maintenance of ventricular fibrillation (VF) and polymorphic ventricular tachycardia (PMVT). Fascicular substrate modification (FSM) approaches have been suggested to treat recurrent VF in case reports and small case series. OBJECTIVES: The aim of this study was to investigate outcomes of catheter-based FSM to treat VF and PMVT. METHODS: Of 2,212 consecutive patients with ventricular arrhythmia undergoing catheter ablation, 18 (0.81%) underwent FSM of the Purkinje fibers as identified with high-density mapping during sinus rhythm. Fascicular substrate and VF initiation were mapped using a multipolar catheter. The endpoint of the ablation was noninducibility of VF and PMVT. In select patients, remapping revealed elimination of the targeted Purkinje potentials. Demographic, clinical, and follow-up characteristics were prospectively collected in our institutional database. RESULTS: A total of 18 patients (mean age 56 ± 3.8 years, 22% women) were included in the study. Of those, 11 (61.1%) had idiopathic VF, 3 (16.7%) had nonischemic cardiomyopathy, and 4 (22.2%) had mixed cardiomyopathy. The average left ventricular ejection fraction was 42.5%. At least 2 antiarrhythmic drugs had failed preablation. At baseline, all patients had inducible VF or PMVT. At the end of the procedure, no patient demonstrated new evidence of fascicular block or bundle branch block. There were no procedure-related complications. After a median follow-up period of 24 months, 16 patients (88.9%) were arrhythmia free on or off drugs: 11 of 11 patients (100%) with idiopathic VF vs 5 of 7 patients (71.4%) with underlying cardiomyopathy (P = 0.06). CONCLUSIONS: Catheter ablation of human VF and PMVT with FSM is feasible and safe and appears highly effective, with high rates of acute VF noninducibility and long-term freedom from recurrent VF.
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BACKGROUND: Atrial fibrillation (AF) ablation carries the risk of silent cerebral event (SCE) and silent cerebral lesion (SCL). Although "silent," these may have long-term clinical implications and are challenging to study as postprocedural magnetic resonance imaging (MRI) is not standard of care. OBJECTIVE: The neurological assessment subgroup (NAS) of ADVENT compared cerebral effects of pulsed field ablation (PFA) with standard-of-care thermal ablation. METHODS: The NAS included consecutive randomized PFA and thermal ablation patients who received postprocedural brain MRI 12-48 hours after ablation. Patients with apparent SCE or SCL findings underwent a modified Rankin scale assessment. MRI images were subsequently reviewed by a blinded brain imaging core laboratory. RESULTS: In total, 77 patients with paroxysmal AF were enrolled at 6 centers; 71 had analyzable scans (34 PFA; 37 thermal ablation). Through individual center review, 6 PFA and 4 thermal scans were identified as SCE/SCL positive, of which 3 PFA and 0 thermal SCE/SCL findings were confirmed by a blinded core laboratory. MRI findings revealed 1 patient with 2- to 4-mm SCEs, 1 patient with a 3-mm SCE, and 1 patient with 2 SCLs (5.5 mm and 11 mm). All modified Rankin scale and National Institutes of Health Stroke Scale scores were 0 before discharge and at 90-day follow-up. There were only 2 neurological safety events (1 transient ischemic attack [PFA] and 1 stroke [thermal ablation]) in the ADVENT study, neither of which was part of the NAS. CONCLUSION: The ADVENT trial provides the first prospective, randomized data on the cerebral impact of PFA and thermal ablation of AF. Incidence of SCE/SCL after ablation in the NAS was low.
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BACKGROUND: Early recurrence of atrial tachyarrhythmias (ERAT) within 3 months of thermal ablation for atrial fibrillation (AF) is common and often considered transient. Pulsed field ablation (PFA) is a nonthermal energy source in which ERAT is not well described. OBJECTIVE: The purpose of this study was to analyze ERAT in patients with AF undergoing PFA in the Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF (PULSED AF) trial. METHODS: This analysis included 154 (52.4%) paroxysmal AF and 140 (47.6%) persistent AF who had ≥10 rhythm assessments during the 90-day blanking period. ERAT was defined as any instance of ≥30 seconds of AF, atrial flutter, or atrial tachycardia on transtelephonic monitoring (weekly and symptomatic) or ≥10 seconds on electrocardiography (at 3 months), both within 90 days. Late recurrence of atrial tachyarrhythmias (LRAT) was defined as observed atrial tachyarrhythmias between 90 days and 12 months. RESULTS: The overall prevalence of ERAT was 27.1% in patients with paroxysmal AF and 31.6% in patients with persistent AF. In patients with ERAT, 73% had ERAT onset within the first month of the procedure. The presence of ERAT was associated with LRAT in patients with paroxysmal AF (hazard ratio 6.4; 95% confidence interval 3.6-11.3) and patients with persistent AF (hazard ratio 3.8; 95% confidence interval 2.2-6.6). Yet, in 29.4% of patients with paroxysmal AF and 34.3% of patients with persistent AF with ERAT, LRAT was not observed. LRAT was positively correlated with the number of ERAT observations. CONCLUSION: ERAT after PFA predicted LRAT in patients with paroxysmal and persistent AF. However, the concept of a blanking period after PFA is still valid, as approximately one-third of patients with ERAT did not continue to have LRAT during follow-up and may not need reablation.
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INTRODUCTION: Both atrial fibrillation (AF) and amyloidosis increase stroke risk. We evaluated the best anticoagulation strategy in AF patients with coexistent amyloidosis. METHODS: Consecutive AF patients with concomitant amyloidosis were divided into two groups based on the postablation stroke-prophylaxis approach; group 1: left atrial appendage occlusion (LAAO) in eligible patients and group 2: oral anticoagulation (OAC). Group 1 patients were further divided into Gr. 1A: LAAO + half-does NOAC (HD-NOAC) for 6 months followed by aspirin 81 mg/day and Gr. 1B: LAAO + HD-NOAC. In group 1 patients, with complete occlusion at the 45-day transesophageal echocardiogram, patients were switched to aspirin, 81 mg/day at 6 months. In case of leak, or dense "smoke" in the left atrium (LA) or enlarged LA, they were placed on long-term half-dose (HD) NOAC. Group 2 patients remained on full-dose NOAC during the whole study period. RESULTS: A total of 92 patients were included in the analysis; group 1: 56 and group 2: 36. After the 45-day TEE, 31 patients from group 1 remained on baby-aspirin and 25 on HD NOAC. At 1-year follow-up, four stroke, one TIA and six device-thrombus were reported in group 1A, compared to none in patients in group 1B (5/31 vs. 0/25, p = .03). No bleeding events were reported in group 1, whereas group 2 had five bleeding events (one subdural hematoma, one retinal hemorrhage, and four GI bleedings). Additionally, one stroke was reported in group 2 that happened during brief discontinuation of OAC. CONCLUSION: In patients with coexistent AF and amyloidosis, half-dose NOAC following LAAO was observed to be the safest stroke-prophylaxis strategy.
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Amiloidosis , Anticoagulantes , Apéndice Atrial , Fibrilación Atrial , Ablación por Catéter , Accidente Cerebrovascular , Humanos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/cirugía , Masculino , Femenino , Apéndice Atrial/diagnóstico por imagen , Apéndice Atrial/fisiopatología , Apéndice Atrial/cirugía , Anciano , Persona de Mediana Edad , Resultado del Tratamiento , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/diagnóstico , Ablación por Catéter/efectos adversos , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Factores de Riesgo , Factores de Tiempo , Amiloidosis/complicaciones , Amiloidosis/diagnóstico , Amiloidosis/diagnóstico por imagen , Hemorragia/inducido químicamente , Administración Oral , Estudios Retrospectivos , Medición de Riesgo , Aspirina/administración & dosificación , Aspirina/efectos adversos , Esquema de Medicación , Cardiomiopatías/diagnóstico por imagen , Cardiomiopatías/complicaciones , Cardiomiopatías/diagnósticoRESUMEN
BACKGROUND: In patients with persistent atrial fibrillation (PerAF), antiarrhythmic drugs (AADs) are considered a first-line rhythm-control strategy, whereas catheter ablation is a reasonable alternative. OBJECTIVES: This study sought to examine the prevalence, patient characteristics, and clinical outcomes of patients with PerAF who underwent catheter ablation as a first or second-line strategy. METHODS: This multicenter observational study included consecutive patients with PerAF who underwent first-time ablation between January 2020 and September 2021 in 9 medical centers in the United States. Patients were divided into those who underwent ablation as first-line therapy and those who had ablation as second-line therapy. Patient characteristics and clinical outcomes were compared between the groups. RESULTS: A total of 2,083 patients underwent first-time ablation for PerAF. Of these, 1,086 (52%) underwent ablation as a first-line rhythm-control treatment. Compared with patients treated with AADs as first-line therapy, these patients were predominantly male (72.6% vs 68.1%; P = 0.03), with a lower frequency of hypertension (64.0% vs 73.4%; P < 0.001) and heart failure (19.1% vs 30.5%; P < 0.001). During a mean follow-up of 325.9 ± 81.6 days, arrhythmia-free survival was similar between the groups (HR: 1.13; 95% CI: 0.92-1.41); however, patients in the second-line ablation strategy were more likely to continue receiving AAD therapy (41.5% vs 15.9%; P < 0.001). CONCLUSIONS: A first-line ablation strategy for PerAF is prevalent in the United States, particularly in men with fewer comorbidities. More data are needed to identify patients with PerAF who derive benefit from an early intervention strategy.
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Antiarrítmicos , Fibrilación Atrial , Ablación por Catéter , Humanos , Fibrilación Atrial/cirugía , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/epidemiología , Fibrilación Atrial/terapia , Masculino , Ablación por Catéter/estadística & datos numéricos , Femenino , Persona de Mediana Edad , Anciano , Antiarrítmicos/uso terapéutico , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
Clinical outcomes of catheter ablation for atrial fibrillation (AF) are suboptimal due, in part, to challenges in achieving durable lesions. Although focal point-by-point ablation allows for the creation of any required lesion set, this strategy necessitates the generation of contiguous lesions without gaps. A large-tip catheter, capable of creating wide-footprint ablation lesions, may increase ablation effectiveness and efficiency. In a randomized, single-blind, non-inferiority trial, 420 patients with persistent AF underwent ablation using a large-tip catheter with dual pulsed field and radiofrequency energies versus ablation using a conventional radiofrequency ablation system. The primary composite effectiveness endpoint was evaluated through 1 year and included freedom from acute procedural failure and repeat ablation at any time, plus arrhythmia recurrence, drug initiation or escalation or cardioversion after a 3-month blanking period. The primary safety endpoint was freedom from a composite of serious procedure-related or device-related adverse events. The primary effectiveness endpoint was observed for 73.8% and 65.8% of patients in the investigational and control arms, respectively (P < 0.0001 for non-inferiority). Major procedural or device-related complications occurred in three patients in the investigational arm and in two patients in the control arm (P < 0.0001 for non-inferiority). In a secondary analysis, procedural times were shorter in the investigational arm as compared to the control arm (P < 0.0001). These results demonstrate non-inferior safety and effectiveness of the dual-energy catheter for the treatment of persistent AF. Future large-scale studies are needed to gather real-world evidence on the impact of the focal dual-energy lattice catheter on the broader population of patients with AF. ClinicalTrials.gov identifier: NCT05120193 .