Comparison Between Extended Cryoablation, Standard Cryoablation, and Radiofrequency Ablation

Comparison of Extended Cryoballoon Ablation, Standard Cryoballoon Ablation, and Radiofrequency Catheter Ablation in Patients With Persistent Atrial Fibrillation: A Multicenter, Randomized Controlled Clinical Trial

The objective of this study is to test the efficacy hypothesis that extended cryoballoon ablation is superior to either standard cryoballoon ablation or radiofrequency ablation

The posterior wall of the left atrium is known to contribute to arrhythmogenicity and has been associated with higher rates of atrial fibrillation (AF) recurrence. In this trial, we aim to evaluate whether extended cryoballoon ablation-comprising pulmonary vein isolation (PVI) plus posterior wall isolation-results in superior rhythm outcomes compared to standard cryoballoon ablation (PVI only) or radiofrequency ablation (PVI only). Patients will be randomly assigned to one of three treatment arms: extended cryoballoon ablation, standard cryoballoon ablation, or radiofrequency ablation. Each patient will receive the assigned treatment accordingly. The primary outcome is the incidence of atrial tachyarrhythmias-including atrial fibrillation, atrial flutter, and atrial tachycardia-lasting more than 30 seconds, occurring after discontinuation of antiarrhythmic drugs and following a 3-month post-procedure blanking period. Outcomes will be compared at 1 year after the procedure.

Inclusion Criteria:

• Patients aged between 18-80 years
• Patients with persistent (≥7 days) AF documented on 12-lead ECG or Holter monitoring.
• AF refractory/intolerant to class I or III antiarrhythmic drugs
• Able and willing to provide written informed consent to CB or RF ablation and participation in this investigation

Exclusion Criteria:

• Age <18 years old or >80 years old
• Paroxysmal AF lasting <7 days
• Mitral stenosis or mechanical prosthetic valve
• Patients with left atrial size ≥ 50 mm (2D echocardiography, Anterior-posterior diameter in parasternal long axis view)
• Anatomy of pulmonary vein not suitable for standard CB or extended CB, including common ostium or ostium size > 26mm
• Pregnant woman of childbearing age with a positive pregnancy test before treatment
• Presence of atrial septal defect or patent foramen ovale closure device
• Presence of intracardiac thrombus
• Contraindications to the systemic anticoagulation
• NYHA functional class IV heart failure
• Prior catheter or surgical ablation of AF
• Acute coronary syndrome within 3 months
• Planned open heart surgery within 3 months
• Prior open-heart surgery within 3 months
• End stage renal disease or chronic kidney disease (estimated glomerular filtration rate [MDRD method] < 30mL/min/1.73m²)
• Life expectancy less than 1 year.