StrokeNCT06253000
Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium
A study testing Cryoablation and Radiofrequency ablation in people with Stroke and Acute Cerebrovascular Accident, run by Bakulev Scientific Center of Cardiovascular Surgery at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Acute Cerebrovascular Accident, Transient Ischemic Attack
- What is being tested?
- Cryoablation and Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteRussia
- Study dates
- 10 Jun 2023to 30 Dec 2026
- Phase
- Interventional
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 80 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;
- Persistent and long-persisting 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
Official title: Comparative Analysis of Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium in Patients With Persistent Atrial Fibrillation
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.
- Conditions
- Stroke, Acute Cerebrovascular Accident, Transient Ischemic Attack, Death, Atrial Fibrillation Recurrent
- Being tested
- Cryoablation, Radiofrequency ablation
- Keywords
- atrial fibrillation, radiofrequency ablation, cryoablation, left atrium, the posterior wall of the left atrium, atrial remodeling
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Death, Atrial Fibrillation, Atrial Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
Cryoablation of the mouths of the pulmonary veins and the posterior wall of the left atrium.
Radiofrequency ablationProcedure or surgery
Radiofrequency ablation of pulmonary veins according to the "box isolation" type using a non-fluoroscopic navigation system.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Active comparator | Cryoablation of the mouths of the pulmonary veins and the posterior wall of the left atrium. Receives: Procedure: Cryoablation |
| Radiofrequency ablation | Active comparator | Radiofrequency ablation of pulmonary veins according to the "box isolation" type using a non-fluoroscopic navigation system. Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral events
The number of patients who had a stroke or acute cerebrovascular accident or a transient ischemic attack within 24 months after ablation.
Measured: From the date of ablation until the date of the event, assessed up to 24 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.
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 24 months.
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 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start10 Jun 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 158 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
- NCT06253000
- Sponsor's protocol ID
- #4.10.11.2022
- Status last verified
- Jul 2025
- First submitted
- 2 Feb 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No