Comparative Evaluation of the Efficacy and Safety of High-Power Short-Duration Radiofrequency Ablation and Standard Low-Power Ablation in Catheter Treatment of Atrial Fibrillation

The study is designed to involve highly specialized centers with substantial clinical experience in the interventional treatment of atrial fibrillation (at least 300 procedures annually) and equipment enabling both conventional low-power radiofrequency ablation (35-45 W) and very high-power short-duration ablation (vHPSD) using the QMODE Plus mode (90 W) for pulmonary vein isolation performed according to the "CLOSE protocol" strategy with non-fluoroscopic navigation systems. The study population will include patients with paroxysmal and persistent forms of atrial fibrillation.

This randomized open-label controlled trial will be conducted with allocation of patients into two groups according to the interventional treatment strategy applied. In the first group, pulmonary vein isolation will be performed using conventional low-power settings (35-45 W), whereas in the second group, pulmonary vein isolation will be carried out using very high-power short-duration ablation (vHPSD) with 90 W energy delivery. Patient randomization will be performed using the sealed-envelope method with a restricted block randomization scheme (block size of 10 patients, with equal allocation of 5 patients to each group). The study is expected to be completed after enrollment of 196 patients.

Inclusion criteria

• Age over 18 years old;
• Atrial fibrillation resistant to antiarrhythmic therapy;
• Paroxysmal form of atrial fibrillation;
• Persistent form of atrial fibrillation;
• The patient's consent to participate in the study.

Exclusion criteria

Exclusion criteria

• Age under 18 and over 80 years old;
• The presence of another cardiac pathology requiring surgical treatment;
• Congenital heart defects;
• Previous "open" cardiac surgery;
• Bone marrow diseases;
• Pathology of the blood coagulation system;
• The left ventricular ejection fraction is less than 40%;
• Moderate to severe renal insufficiency (creatinine clearance <50 ml/min);
• Drug-resistant hypertension (despite hypotensive therapy);
• Organically altered mitral valve;
• There are reasons to assume that the patient will not show up for subsequent visits (control points of the study) for various reasons;
• The patient's participation in another clinical trial.