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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBakulev Scientific Center of Cardiovascular Surgery

About this trial

Atrial fibrillation (AF) is the most common cardiac arrhythmia and represents one of the leading causes of cardiovascular morbidity and mortality. According to current data, AF is associated with approximately 20% of all ischemic strokes, while the risk of stroke in patients with this arrhythmia is increased fivefold. Ischemic stroke in patients with AF is characterized by a more severe clinical course, more frequently results in death, is associated with significant disability, and carries a higher risk of recurrence compared with strokes of other etiologies. Consequently, the risk of death in patients with AF-associated stroke is doubled, while the economic costs of treatment increase by an average of 1.5 times.

The aim of the present study is to perform a comparative evaluation of the efficacy of two interventional treatment strategies for atrial fibrillation: very high-power short-duration radiofrequency ablation (90 W) and conventional low-power radiofrequency ablation (35-45 W) for pulmonary vein isolation using the "CLOSE protocol" approach with a non-fluoroscopic navigation system. The efficacy of the interventions will be assessed both in the early postoperative period and during long-term follow-up over 12 months.

Eligibility criteria

Qualifiers

Age over 18 years old;

Atrial fibrillation resistant to antiarrhythmic therapy;

Paroxysmal form of atrial fibrillation;

Persistent form of atrial fibrillation;

Disqualifiers

Age under 18 and over 80 years old;

The presence of another cardiac pathology requiring surgical treatment;

Congenital heart defects;

Previous "open" cardiac surgery;

Trial design

Treatments tested in this trial

  • Technique of radiofrequency ablation using very high-power short-duration ablation parameters
  • Technique of radiofrequency ablation using low-power settings

Treatment groups

196 Participants
are divided into 2 treatment groups