Atrial Fibrillation (AF)NCT07728539
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
A study testing Technique of radiofrequency ablation using very high-power short-duration ablation parameters and Technique of radiofrequency ablation using low-power settings in people with Atrial Fibrillation (AF) and Stroke, run by Bakulev Scientific Center of Cardiovascular Surgery at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation (AF), Stroke, Acute Cerebrovascular Accident
- What is being tested?
- Technique of radiofrequency ablation using very high-power short-duration ablation parameters and Technique of radiofrequency ablation using low-power settings
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteRussia
- Study dates
- 15 Jun 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Bakulev National Medical Research Center for Cardiovascular Surgery
Moscow, 121552
Grayr Avanesyan, +7(987)-333-18-88, gaavanesyan@bakulev.ru
About this study
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.
Read the detailed description
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.
- Conditions
- Atrial Fibrillation (AF), Stroke, Acute Cerebrovascular Accident, Atrial Fibrillation Recurrent, Death
- Being tested
- Technique of radiofrequency ablation using very high-power short-duration ablation parameters, Technique of radiofrequency ablation using low-power settings
- Keywords
- Radiofrequency ablation, high-power short-duration ablation, very high-power short-duration ablation, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation, Stroke, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technique of radiofrequency ablation using very high-power short-duration ablation parametersProcedure or surgery
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.
Technique of radiofrequency ablation using low-power settingsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Technique of radiofrequency ablation using very high-power short-duration ablation parameters | Active comparator | Technique of radiofrequency ablation using very high-power short-duration ablation parameters Receives: Procedure: Technique of radiofrequency ablation using very high-power short-duration ablation parameters |
| Technique of radiofrequency ablation using low-power settings | Active comparator | Technique of radiofrequency ablation using low-power settings Receives: Procedure: Technique of radiofrequency ablation using low-power settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of AF
The number of patients with recurrent atrial fibrillation after surgery
Measured: From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 12 months
Secondary outcomes (4)
Hospital mortality
The number of patients who died in the hospital
Measured: 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)
Measured: 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
Measured: 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
Measured: From the date of ablation until the date of the event, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start15 Jun 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized double-blind controlled trial in two groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakulev Scientific Center of Cardiovascular Surgery
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Andrey Filatov, Principal investigator, Bakulev Scientific Center for Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728539
- Sponsor's protocol ID
- #2.29.05.2025
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07728539
- Acronym / sponsor ID
- #2.29.05.2025
- Conditions
- Atrial Fibrillation (AF), Stroke, Acute Cerebrovascular Accident, Atrial Fibrillation Recurrent, Death
- Keywords
- Radiofrequency ablation, high-power short-duration ablation, very high-power short-duration ablation, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Bakulev Scientific Center of Cardiovascular SurgeryOther government
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized double-blind controlled trial in two groups
| Arm | Type | Receives |
|---|---|---|
| Technique of radiofrequency ablation using very high-power short-duration ablation parameters | Active comparator | Procedure: Technique of radiofrequency ablation using very high-power short-duration ablation parametersTechnique of radiofrequency ablation using very high-power short-duration ablation parameters |
| Technique of radiofrequency ablation using low-power settings | Active comparator | Procedure: Technique of radiofrequency ablation using low-power settingsTechnique of radiofrequency ablation using low-power settings |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technique of radiofrequency ablation using very high-power short-duration ablation parametersRadiofrequency 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. | Procedure or surgery | Technique of radiofrequency ablation using very high-power short-duration ablation parameters |
| Technique of radiofrequency ablation using low-power settingsRadiofrequency 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. | Procedure or surgery | Technique of radiofrequency ablation using low-power settings |
Primary outcome
Recurrence of AF
Time frame: From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 12 months
The number of patients with recurrent atrial fibrillation after surgery
4 secondary outcomes
Hospital mortality
Time frame: From the date of ablation until the date of death, assessed up to 5 days
Non-lethal events
Time frame: From the date of ablation to the date of any of the listed events, assessed up to 5 days
Long-term mortality
Time frame: From the date of ablation until the date of death, assessed up to 12 months
Cerebral events
Time frame: From the date of ablation until the date of the event, assessed up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrey Filatov principal investigator
Bakulev Scientific Center for Cardiovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technique of radiofrequency ablation using very high-power short-duration ablation parameters and Technique of radiofrequency ablation using low-power settings in people with Atrial Fibrillation (AF) and Stroke, run by Bakulev Scientific Center of Cardiovascular Surgery at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrey Filatov (+7(495) 414-77-02, agfilatov@bakulev.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of AF (time frame: From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.