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
1 other identifier
interventional
196
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2026
CompletedFirst Submitted
Initial submission to the registry
July 22, 2026
CompletedFirst Posted
Study publicly available on registry
July 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
July 27, 2026
July 1, 2026
2 years
July 22, 2026
July 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence of AF
The number of patients with recurrent atrial fibrillation after surgery
From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 12 months
Secondary Outcomes (4)
Hospital mortality
From the date of ablation until the date of death, assessed up to 5 days
Non-lethal events
From the date of ablation to the date of any of the listed events, assessed up to 5 days
Long-term mortality
From the date of ablation until the date of death, assessed up to 12 months
Cerebral events
From the date of ablation until the date of the event, assessed up to 12 months
Study Arms (2)
Technique of radiofrequency ablation using very high-power short-duration ablation parameters
ACTIVE COMPARATORTechnique of radiofrequency ablation using very high-power short-duration ablation parameters
Technique of radiofrequency ablation using low-power settings
ACTIVE COMPARATORTechnique of radiofrequency ablation using low-power settings
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bakulev National Medical Research Center for Cardiovascular Surgery
Moscow, 121552, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrey Filatov
Bakulev Scientific Center for Cardiovascular Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2026
First Posted
July 27, 2026
Study Start
June 15, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2029
Last Updated
July 27, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share