Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium

Bakulev Scientific Center of Cardiovascular Surgery

Status: Enrolling

Conditions: Death; Stroke; Atrial Fibrillation Recurrent; Transient Ischemic Attack; Acute Cerebrovascular Accident

Treatments: Procedure: Radiofrequency ablation; Procedure: Cryoablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06253000

#4.10.11.2022

Details and patient eligibility

About

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.

Enrollment: 158 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

Cryoablation

Active Comparator group

Description:

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

Treatment:

Procedure: Cryoablation

Radiofrequency ablation

Active Comparator group

Description:

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

Treatment:

Procedure: Radiofrequency ablation