Redo-Pulmonary Vein Isolation With Versus Without Posterior Wall Ablation - The REDO-PIFPAF-PFA Study

Prior treatment

• Previous LA surgery
• \> 1 prior LA ablation
• AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
• Prior mitral valve surgery
• Ongoing triple antithrombotic/anticoagulation therapy

Other illness

• Myocardial infarction during the 3-month period preceding the consent date
• Cardiac surgery during the 3-month interval preceding the informed consent date or scheduled cardiac surgery/transcatheter aortic valve implantation procedure
• Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including a patent foramen ovale)
• New York Heart Association (NYHA) class III or IV congestive heart failure
• Cerebral ischemic event (stroke or TIA) during the 6-month interval preceding the informed consent date
• Ongoing systemic infections
• Cardiac amyloidosis

Lab values

• Left ventricular ejection fraction (LVEF) \<35%
• Significant chronic kidney disease (eGFR \<30 ml/min)

Age

• Patients in persistent AF lasting \>3 years
• Pregnancy (to exclude pregnancy a blood test (HCG) is performed in women \< 50 years before inclusion)

Other

• LA ablation outside of the PVs in the first LA ablation
• LA diameter \>60 mm in the parasternal long axis
• Pre-existing PV stenosis or PV stent
• Pre-existing hemidiaphragmatic paralysis
• Contraindication to anticoagulation or radiocontrast materials
• Severe mitral regurgitation or moderate/severe mitral stenosis
• Hypertrophic cardiomyopathy or left septal wall thickness \>1.5 cm
• Uncontrolled hyperthyroidism
• Life expectancy less than one year per physician opinion
• Currently participating in any other clinical trial, which may confound the results of this trial.
• Unwilling or unable to comply fully with the study procedures and FU.

• Documented recurrence of paroxysmal or persistent AF following single prior catheter ablation with PVI, confirmed by 12-lead ECG, Holter monitoring, or ICM within the last 2 years.
• Candidate for repeat catheter ablation according to current European Society of Cardiology (ESC) AF management guidelines.
• Continuous oral anticoagulation with a vitamin K antagonist or non-vitamin K oral anticoagulant (NOAC) for ≥ 4 weeks prior to the ablation, or transoesophageal echocardiography (TEE) and/or cardiac computed tomography (CT) within 48 hours before the procedure excluding LA thrombus.
• Age ≥ 18 years at the time of informed consent.
• Written informed consent obtained prior to any study-related procedures.