RecruitingNot ApplicableNCT07728539

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


Sponsor

Bakulev Scientific Center of Cardiovascular Surgery

Enrollment

196 participants

Start Date

Jun 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • 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 Criteria12

  • 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.

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Interventions

PROCEDURETechnique of radiofrequency ablation using very high-power short-duration ablation parameters

Radiofrequency ablation is performed in QMODE Plus mode (90 W, 4 s per application) with esophageal temperature monitoring (not exceeding 38.5 °C), using a steerable introducer and a contact force of 5-15 g.

PROCEDURETechnique of radiofrequency ablation using low-power settings

Radiofrequency ablation is performed at a power of 35 W and an application duration of 10-15 s with monitoring of the ablation index (400-550 depending on the anatomical zone), esophageal temperature (not exceeding 38.5 °C), and a contact force of 5-15 g.


Locations(1)

Bakulev National Medical Research Center for Cardiovascular Surgery

Moscow, Russia

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NCT07728539


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