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NCT Number: NCT06253000

Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium

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.

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Key information

Conditions

Stroke Acute Cerebrovascular Accident Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation Recurrent Atrial Remodeling Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Death Heart Diseases Ischemic Attack, Transient Nervous System Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Transient Ischemic Attack Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakulev National Medical Research Center for Cardiovascular Surgery

Moscow, 121552, Russia

Location status: Recruiting

Location contact

Grayr Avanesyan

CONTACT

[email protected]

+7(987)-333-18-88

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cryoablation

Procedure

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

Radiofrequency ablation

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrey Filatov

CONTACT

[email protected]

+7(495) 414-77-02

Sponsors and collaborators

Lead sponsor

Bakulev Scientific Center of Cardiovascular Surgery

Other Gov

Registry information

Official study title

Comparative Analysis of Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium in Patients With Persistent Atrial Fibrillation

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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