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RecruitingNCT06253000Updated Jul 20, 2026

Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium

An interventional study of Cryoablation and Radiofrequency ablation in Stroke, Acute Cerebrovascular Accident and Transient Ischemic Attack, sponsored by Bakulev Scientific Center of Cardiovascular Surgery. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Bakulev Scientific Center of Cardiovascular Surgery · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jun 2023, registered Feb 2024).
  • Started Jun 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
158
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Atrial fibrillation (AF) is the cause of 20% of strokes, and the risk of stroke in a person suffering from this arrhythmia increases by 5 times. Ischemic stroke in patients with AF is often fatal and, compared with stroke of other etiology, leads to the most pronounced disability and more often recurs. Accordingly, the risk of death in patients with AF-related stroke is 2 times higher, and treatment costs increase 1.5 times.

The main interventional method of treating AF, available in most medical institutions, is the use of radio frequency and/or cryoenergy to eliminate destructive damage to the left atrium (LA).

The aim of this study is to compare two different interventional methods and identify predictors of recurrence in patients with persistent and long-term AF.

02

Conditions studied

  • Stroke
  • Acute Cerebrovascular Accident
  • Transient Ischemic Attack
  • Death
  • Atrial Fibrillation Recurrent

Keywords

  • atrial fibrillation
  • radiofrequency ablation
  • cryoablation
  • left atrium
  • the posterior wall of the left atrium
  • atrial remodeling
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 158 is above the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age over 18 years old;
  • Atrial fibrillation resistant to antiarrhythmic therapy;
  • Persistent and long-persisting 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 is less than 40%;
  • Moderate to severe renal insufficiency ( \<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.
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
158 participants (estimated)

Study arms

  • Active comparator
    Cryoablation

    Cryoablation of the mouths of the pulmonary veins and the posterior wall of the left atrium.

    Procedure: Cryoablation

  • Active comparator
    Radiofrequency ablation

    Radiofrequency ablation of pulmonary veins according to the "box isolation" type using a non-fluoroscopic navigation system.

    Procedure: Radiofrequency ablation

Interventions

  • ProcedureCryoablation

    Cryoablation of the mouths of the pulmonary veins and the posterior wall of the left atrium.

  • ProcedureRadiofrequency ablation

    Radiofrequency ablation of pulmonary veins according to the "box isolation" type using a non-fluoroscopic navigation system.

06

What researchers measure

Primary outcomes

  1. Cerebral events

    The number of patients who had a stroke or acute cerebrovascular accident or a transient ischemic attack within 24 months after ablation.

    Time frame: From the date of ablation until the date of the event, assessed up to 24 months.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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 24 months.

  4. 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 24 months.

07

Study locations

1 of 1 sites recruiting
  • Bakulev National Medical Research Center for Cardiovascular Surgery
    Moscow, 121552, Russia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2023 (actual). Primary completion is estimated for Dec 2026, 42 months after the start.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 42 months is above that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2024
First posted
Feb 12, 2024
StartActual
Jun 10, 2023
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 30, 2026
Last update
Jul 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06253000
Lead sponsor
Bakulev Scientific Center of Cardiovascular Surgery
Responsible party
Sponsor
First posted
Feb 12, 2024
Start date
Jun 10, 2023
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jul 20, 2026

Study contacts

Andrey Filatov
Contact
agfilatov@bakulev.ru
+7(495) 414-77-02
Andrey Filatov
principal investigator · Bakulev Scientific Center for Cardiovascular Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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