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
Recruiting · NCT07728539 · Interventional (participants receive a specific treatment) · Lead sponsor: Bakulev Scientific Center of Cardiovascular Surgery
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Bakulev National Medical Research Center for Cardiovascular Surgery - Moscow, Russia