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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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
Bakulev National Medical Research Center for Cardiovascular Surgery
RECRUITING
Moscow
Contact Information
Primary
Andrey Filatov
agfilatov@bakulev.ru
+7(495) 414-77-02
Time Frame
Start Date: 2026-06-15
Estimated Completion Date: 2029-06-01
Participants
Target number of participants: 196
Treatments
Active_comparator: Technique of radiofrequency ablation using very high-power short-duration ablation parameters
Technique of radiofrequency ablation using very high-power short-duration ablation parameters
Active_comparator: Technique of radiofrequency ablation using low-power settings
Technique of radiofrequency ablation using low-power settings
Related Therapeutic Areas
Sponsors
Leads: Bakulev Scientific Center of Cardiovascular Surgery

This content was sourced from clinicaltrials.gov