Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium

Not Applicable

Recruiting

• Conditions: Death; Acute Cerebrovascular Accident; Stroke; Transient Ischemic Attack; Atrial Fibrillation Recurrent
• Interventions: Procedure: Cryoablation; Procedure: Radiofrequency ablation

• Registration Number: NCT06253000
• Lead Sponsor: Bakulev Scientific Center of Cardiovascular Surgery

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-10
• Status Verified: 2024-02
• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-12
• Last Update Posted: 2024-02-12
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 158

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryoablation	Cryoablation	Cryoablation of the mouths of the pulmonary veins and the posterior wall of the left atrium.
Radiofrequency ablation	Radiofrequency ablation	Radiofrequency ablation of pulmonary veins according to the "box isolation" type using a non-fluoroscopic navigation system.

Primary Outcome Measures

Name	Time	Method
Cerebral events	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 Outcome Measures

Name	Time	Method
Hospital mortality	From the date of ablation until the date of death, assessed up to 5 days.	The number of patients who died in the hospital.
Recurrence of AF	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.
Long-term mortality	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.
Non-lethal events	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).

Trial Locations

Locations (1)

Bakulev National Medical Research Center for Cardiovascular Surgery; 🇷🇺 Moscow, Russian Federation