AIMS: Clinical studies with protocol-mandated workflow and monitoring have analysed performance of pulsed field ablation (PFA) for treating atrial fibrillation (AF). The FARADISE registry captures global use of the pentaspline PFA catheter in real-world clinical practice with a follow-up of 3 years. METHODS AND RESULTS: FARADISE is a prospective, non-randomized, multi-national registry (NCT05501873) that enrolled subjects clinically indicated for ablation using the pentaspline PFA catheter per medical judgement and hospital standard-of-care. Procedural characteristics, safety, and clinical effectiveness up to 12-months were collected. In total, 1158 AF patients received PFA across 48 centres in 21 countries (64 ± 11 years, 33% female, 90% de novo, 65% paroxysmal AF). Pulmonary vein isolation (PVI)-only procedures were performed in 80.8% of paroxysmal vs. 57.5% for non-paroxysmal patients (P < 0.01). Median procedure, left atrial dwell, and fluoroscopy times were 51[40-70], 31[24-41], and 12[8-17] min, respectively. The rate of early onset serious adverse events was 1.5% and did not differ by ablation strategy or AF indication. At 1-year, clinical effectiveness was 80.8% for paroxysmal AF and 67.7% for non-paroxysmal AF, with no difference within indication by lesion set (paroxysmal: 81.2% PVI-only vs. 79.0% PVI+, P = 0.65; non-paroxysmal: 67.5% PVI-only vs. 67.7% PVI+, P = 0.79). Acute results reinforce a short procedural learning curve with no difference in 1-year effectiveness by operator experience. CONCLUSION: The FARADISE registry provides a snapshot of real-world clinical use of the pentaspline PFA catheter. Acute results demonstrate favourable procedural and safety outcomes regardless of AF indication. One-year outcomes are encouraging, with no differences seen within indication based on ablation strategy.

• Keywords
• Atrial fibrillation, Learning curve, Pulsed field ablation, Real-world,
• MeSH
• Time Factors MeSH
• Equipment Design MeSH
• Atrial Fibrillation * surgery   physiopathology   diagnosis   MeSH
• Catheter Ablation * instrumentation   adverse effects   methods   MeSH
• Middle Aged MeSH
• Humans MeSH
• Prospective Studies MeSH
• Recurrence MeSH
• Registries MeSH
• Aged MeSH
• Cardiac Catheters * MeSH
• Pulmonary Veins * surgery   physiopathology   MeSH
• Treatment Outcome MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Observational Study MeSH

AIMS: Initial clinical studies of pulsed field ablation (PFA) to treat atrial fibrillation (AF) indicated a >90% durability rate of pulmonary vein isolation (PVI). However, these studies were largely conducted in single centres and involved a limited number of operators. We aimed to describe the electrophysiological findings and outcomes in patients undergoing repeat ablation after an initial PF ablation for AF. METHODS AND RESULTS: In the MANIFEST-REDO study, we investigated patients who underwent repeat ablation due to clinical recurrence-AF or atrial tachycardia (AT)-following first-ever PVI with a pentaspline PFA catheter (Farawave, Boston Scientific Inc.). At 22 centres, 427 patients (age 64 ± 11 years; 37% female) were included. Of note, the recurrent arrhythmia leading to the repeat ablation was paroxysmal AF (51%), persistent AF (30%), or AT (19%). At the repeat procedure, the PV reconnection rates were 30% (left superior pulmonary vein), 28% (left inferior pulmonary vein), 33% (right superior pulmonary vein), and 32% (right inferior pulmonary vein). In 45% of patients, all PVs were durably isolated at the beginning of the repeat procedure, with the previous use of any imaging or mapping modality being univariately associated with durable PVI. After a post-redo follow-up period of 284 (90-366) days, the primary effectiveness endpoint (freedom from documented AF/AT lasting ≥30 s after 3-month blanking without class I/III antiarrhythmic drugs or symptoms) was achieved in 65% of patients, with significant differences between groups (PAF 65% vs. PersAF 56% vs. AT 76%; P = 0.04). Persistent AF as recurrent arrhythmia after the initial PFA ablation predicted AT/AF recurrence after repeat ablation [hazard ratio 1.241 (95% confidence interval 1.534-1.005); P = 0.045]. The procedural complication rate was 2.8%. CONCLUSION: In repeat procedures for AF/AT performed after an index procedure with PFA for AF, PV reconnections are not uncommon. Repeat procedures can be performed safely and with an acceptable subsequent success rate.

• Keywords
• Atrial fibrillation, Atrial tachycardia, Electroporation, Pulmonary vein isolation, Pulsed field ablation,
• MeSH
• Action Potentials MeSH
• Time Factors MeSH
• Electrophysiologic Techniques, Cardiac MeSH
• Atrial Fibrillation * surgery   physiopathology   diagnosis   MeSH
• Catheter Ablation * adverse effects   methods   MeSH
• Middle Aged MeSH
• Humans MeSH
• Recurrence MeSH
• Reoperation MeSH
• Risk Factors MeSH
• Aged MeSH
• Heart Rate MeSH
• Tachycardia, Supraventricular * surgery   physiopathology   diagnosis   MeSH
• Pulmonary Veins * surgery   physiopathology   MeSH
• Treatment Outcome MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH

AIMS: Pulsed field ablation (PFA) is a growing ablation modality for pulmonary vein isolation (PVI) in atrial fibrillation (AF) patients. This study assesses the 6-month safety and effectiveness of a novel balloon-in-basket, mapping-integrated PFA system, with a purpose-built form factor for PVI. METHODS AND RESULTS: The VOLT CE Mark Study is a prospective, multi-center, pre-market study. A total of 150 patients with drug-refractory paroxysmal (PAF) or persistent AF (PersAF) were enrolled between 8 November 2023 and 14 March 2024, of which 146 patients (age 64.1 ± 10.0 years, 63.0% male, 70.5% PAF) underwent PVI with the balloon-in-basket PFA catheter and system featuring integrated electroanatomic mapping with contact-sensing. Study endpoints were the rate of primary serious adverse events within 7 days as well as acute procedural effectiveness and 6-month freedom from recurrence. Acute effectiveness was achieved in 99.1% (573/578) of treated PVs (98.6% of patients, 144/146) with 17.6 ± 5.7 PFA applications/patient. Procedure, fluoroscopy, LA dwell, and transpired ablation times were 100.4 ± 33.0, 17.3 ± 12.1, 39.4 ± 20.6, and 31.4 ± 16.8 min, respectively. There were 4 (2.7%; 4/146) primary serious adverse events. The rate of freedom from documented atrial arrhythmias was 88.2% in PAF patients and 76.7% in PersAF patients (freedom from symptomatic recurrence was documented in 90.2% of PAF patients and 74.4% of PersAF patients) through 6-months post-index procedure. CONCLUSION: The VOLT CE Mark Study primary results demonstrate the safety and effectiveness of the novel balloon-in-basket PFA system to perform PVI in PAF and PersAF.

• Keywords
• Atrial fibrillation, Balloon, Balloon-in-basket, Basket, Catheter ablation, Pulmonary vein isolation, Pulsed field ablation, Single-shot,
• MeSH
• Time Factors MeSH
• Atrial Fibrillation * surgery   physiopathology   diagnosis   MeSH
• Catheter Ablation * instrumentation   adverse effects   methods   MeSH
• Middle Aged MeSH
• Humans MeSH
• Prospective Studies MeSH
• Recurrence MeSH
• Aged MeSH
• Pulmonary Veins * surgery   physiopathology   MeSH
• Treatment Outcome MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial MeSH
• Multicenter Study MeSH

AIMS: Catheter ablation is an effective treatment method for recurrent ventricular tachycardias (VTs). However, at least in part, procedural and clinical outcomes are limited by challenges in generating an adequate lesion size in the ventricular myocardium. We investigated procedural and clinical outcomes of VT ablation using a novel 'large-footprint' catheter that allows the creation of larger lesions either by radiofrequency (RF) or by pulsed field (PF) energy. METHODS AND RESULTS: In prospectively collected case series, we describe our initial experience with VT ablation using a lattice-tip, dual-energy catheter (Sphere-9, Medtronic), and a compatible proprietary electroanatomical mapping system (Affera, Medtronic). The study population consisted of 18 patients (aged 55 ± 15 years, one woman, structural heart disease: 94%, ischaemic heart disease: 56%, left ventricular ejection fraction: 34 ± 10%, electrical storm: 22%) with recurrent sustained VTs and ≥1 previously failed endocardial RF ablation with conventional irrigated-tip catheter in 66% of patients. On average, 12 ± 7 RF and 8 ± 9 PF applications were delivered per patient. In three-fourths of patients undergoing percutaneous epicardial ablation, spasms in coronary angiography were observed after PF applications. All resolved after intracoronary administration of nitrates. No acute phrenic nerve palsy was noted. One patient suffered from a stroke that resolved without sequelae. Post-ablation non-inducibility of VT was achieved in 89% of patients. Ventricular-arrhythmia-free survival at three months was 78%. CONCLUSION: VT ablation using a dual-energy lattice-tip catheter and a novel electroanatomical mapping system is feasible. It allows rapid mapping and effective substrate modification with good outcomes during short-term follow-up.

• Keywords
• Catheter ablation, Pulsed field, Radiofrequency ablation, Ventricular tachycardia,
• MeSH
• Action Potentials MeSH
• Time Factors MeSH
• Equipment Design MeSH
• Progression-Free Survival MeSH
• Adult MeSH
• Electrophysiologic Techniques, Cardiac * MeSH
• Catheter Ablation * methods   instrumentation   adverse effects   MeSH
• Tachycardia, Ventricular * surgery   physiopathology   diagnosis   MeSH
• Middle Aged MeSH
• Humans MeSH
• Prospective Studies MeSH
• Recurrence MeSH
• Aged MeSH
• Cardiac Catheters * MeSH
• Feasibility Studies * MeSH
• Treatment Outcome MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH