Comparative Evaluation of the Efficacy and Safety of High-Power Short-Duration Radiofrequency Abl… (NCT07728539) | Clinical Trial Compass
RecruitingNot Applicable
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
Russia196 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrence of AF
Timeframe: From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 12 months
Trial details
NCT IDNCT07728539
SponsorBakulev Scientific Center of Cardiovascular Surgery