Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium

May 7, 2026 updated by: Bakulev Scientific Center of Cardiovascular Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russia
      • Moscow, Russia, 121552
        • Recruiting
        • Bakulev National Medical Research Center for Cardiovascular Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cryoablation
Cryoablation of the mouths of the pulmonary veins and the posterior wall of the left atrium.
Procedure: Cryoablation
Cryoablation of the mouths of the pulmonary veins and the posterior wall of the left atrium.
Active Comparator: Radiofrequency ablation
Radiofrequency ablation of pulmonary veins according to the "box isolation" type using a non-fluoroscopic navigation system.
Procedure: Radiofrequency ablation
Radiofrequency ablation of pulmonary veins according to the "box isolation" type using a non-fluoroscopic navigation system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral events
Time Frame: From the date of ablation until the date of the event, assessed up to 24 months.
The number of patients who had a stroke or acute cerebrovascular accident or a transient ischemic attack within 24 months after ablation.
From the date of ablation until the date of the event, assessed up to 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital mortality
Time Frame: From the date of ablation until the date of death, assessed up to 5 days.
The number of patients who died in the hospital.
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.
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).
From the date of ablation to the date of any of the listed events, assessed up to 5 days.
Recurrence of AF
Time Frame: From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 24 months.
The number of patients with recurrent atrial fibrillation after surgery.
From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 24 months.
Long-term mortality
Time Frame: From the date of ablation until the date of death, assessed up to 24 months.
The number of patients who died during the follow-up period.
From the date of ablation until the date of death, assessed up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakulev Scientific Center of Cardiovascular Surgery

Investigators

  • Principal Investigator: Andrey Filatov, Bakulev Scientific Center for Cardiovascular Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #4.10.11.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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