An interventional study of Technique of radiofrequency ablation using very high-power short-duration ablation parameters and Technique of radiofrequency ablation using low-power settings in Atrial Fibrillation (AF), Stroke and Acute Cerebrovascular Accident, sponsored by Bakulev Scientific Center of Cardiovascular Surgery. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Bakulev Scientific Center of Cardiovascular Surgery · Not applicable, Interventional, and Treatment
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.
The study is designed to involve highly specialized centers with substantial clinical experience in the interventional treatment of atrial fibrillation (at least 300 procedures annually) and equipment enabling both conventional low-power radiofrequency ablation (35-45 W) and very high-power short-duration ablation (vHPSD) using the QMODE Plus mode (90 W) for pulmonary vein isolation performed according to the "CLOSE protocol" strategy with non-fluoroscopic navigation systems. The study population will include patients with paroxysmal and persistent forms of atrial fibrillation.
This randomized open-label controlled trial will be conducted with allocation of patients into two groups according to the interventional treatment strategy applied. In the first group, pulmonary vein isolation will be performed using conventional low-power settings (35-45 W), whereas in the second group, pulmonary vein isolation will be carried out using very high-power short-duration ablation (vHPSD) with 90 W energy delivery. Patient randomization will be performed using the sealed-envelope method with a restricted block randomization scheme (block size of 10 patients, with equal allocation of 5 patients to each group). The study is expected to be completed after enrollment of 196 patients.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 196 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Bakulev Scientific Center of Cardiovascular Surgery is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Technique of radiofrequency ablation using very high-power short-duration ablation parameters
Procedure: Technique of radiofrequency ablation using very high-power short-duration ablation parameters
Technique of radiofrequency ablation using low-power settings
Procedure: Technique of radiofrequency ablation using low-power settings
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.
Recurrence of AF
The number of patients with recurrent atrial fibrillation after surgery
Time frame: From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 12 months
Hospital mortality
The number of patients who died in the hospital
Time frame: From the date of ablation until the date of death, assessed up to 5 days
Non-lethal events
Number of participants with non-lethal events. The main hospital non-lethal events (bleeding, tamponade, perforation of the walls of the heart, damage to the esophagus)
Time frame: From the date of ablation to the date of any of the listed events, assessed up to 5 days
Long-term mortality
The number of patients who died during the follow-up period
Time frame: From the date of ablation until the date of death, assessed up to 12 months
Cerebral events
The number of patients who had a stroke or acute cerebrovascular accident or a transient ischemic attack within 12 months after ablation
Time frame: From the date of ablation until the date of the event, assessed up to 12 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bakulev Scientific Center of Cardiovascular Surgery