Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter

Inclusion criteria

Participants must meet all the following criteria:

• Age ≥18 years
• Persistent AF, defined as continuous AF lasting at least 7 days
• Indication for catheter ablation according to the latest ESC guidelines
• Written informed consent

Exclusion criteria

Participants will be excluded if any of the following criteria apply:

• Inability or unwillingness to provide informed consent
• Continuous AF duration duration of ≥2 years
• Documented atrial tachycardia or atrial flutter
• Previous left atrial catheter ablation or cardiac surgery
• Planned cardiac surgery within the first 3 months after inclusion
• History of heart transplantation, current listing for transplantation, or planned cardiac assist device implantation
• Severe mitral or aortic valvular disease, according to the ESC guidelines
• Platelet count <50,000 cells/mm³
• Body mass index >45 kg/m² or <18 kg/m²
• Untreated thyroid dysfunction (patients may be included once hypothyroidism or hyperthyroidism is adequately treated)
• Absolute contraindication to oral anticoagulation
• Any comorbidity that limits life expectancy to <1 year
• Active systemic infection (enrolment permitted after successful treatment)
• Women who are pregnant or breastfeeding
• Women of childbearing potential not using highly effective contraception (PEARL Index <1%)
• End-stage renal disease (GFR <15 ml/min/1.73 m2) or hepatic failure (Child Pugh C)
• Acutely decompensated heart failure (NYHA IV), inclusion is possible only after stabilization to a NYHA functional status better than IV
• Participation in another randomized controlled trial