Lattice vs Pentaspline Comparative Evaluation in Persistent AF

LANCE-AF is a prospective, multicenter, multinational, randomized, non-inferiority trial comparing two pulsed-field ablation catheter technologies-the Sphere-9 lattice-tip catheter and the FARAPULSE pentaspline catheter-in patients with symptomatic persistent atrial fibrillation. In both treatment groups, atrial fibrillation ablation will be restricted to pulmonary vein isolation. Empirical left atrial substrate modification will not be permitted. An insertable cardiac rhythm monitor will be implanted during the index procedure to provide continuous rhythm monitoring for 12 months. The primary objective is to determine whether ablation using the Sphere-9 catheter is non-inferior to ablation using the FARAPULSE catheter with respect to acute pulmonary vein isolation and freedom from treatment failure through 12 months. Secondary objectives include comparisons of procedural safety, postablation atrial arrhythmia burden, longest atrial arrhythmia episode, quality of life, and procedural efficiency.

Inclusion Criteria: * Age ≥ 18 years * Symptomatic AF (EHRA symptom class ≥ II) * Documented persistent AF (continuous AF for \> 7 days and \< 365 days), confirmed within 180 days of enrollment by either a 24-hour Holter recording showing continuous AF, or two ECGs from any regulatory-cleared rhythm monitoring device, taken at least 7 days apart, showing continuous AF * Patients considered eligible for catheter ablation (either refractory/intolerant to ≥1 Class I/III AAD or presenting for first-line ablation per clinical discretion) * Willing and capable of undergoing insertable loop recorder (ILR) implantation at the index procedure and maintaining the conditions required for automatic remote transmission throughout the 12-month study period * Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center Exclusion Criteria: Anatomical and procedural exclusions * Previous catheter or surgical ablation, except right-sided atrial ablation for supraventricular tachycardia or cavotricuspid isthmus ablation for atrial flutter * Severe left atrial enlargement: left atrial anteroposterior diameter ≥55 mm or LAVI \>50 mL/m2 * Left atrial or left atrial appendage (LA/LAA) thrombus * Prior pulmonary vein intervention, pulmonary vein stenting, or known severe pulmonary vein stenosis * Presence of an interatrial baffle, ASD/PFO closure device, or surgical patch that, in the investigator's judgment, precludes safe transseptal access Cardiovascular exclusions * New York Heart Association (NYHA) functional class III or IV * Recent acute coronary syndrome, coronary revascularization, cardiac surgery, stroke, or transient ischemic attack within the preceding 90 days * Severe valvular heart disease or prosthetic heart valve/annuloplasty ring * History of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF). * Atrial fibrillation secondary to reversible non-cardiac causes. Other exclusions * Presence of an insertable cardiac device (pacemaker, ICD, CRT, or pre-existing non-study ILR) * Contraindication or intolerance to therapeutic systemic anticoagulation * Documented baseline hemi-diaphragmatic paresis or paralysis * Inability, unwillingness, or anatomical contraindication (e.g., implant-site skin or soft-tissue pathology, prior radiation, or chest-wall deformity) to undergo ILR implantation * Severe renal impairment: eGFR\