Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium

NCT06253000 | Recruiting

• 1 other identifier: #4.10.11.2022
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

atrial fibrillation; radiofrequency ablation; cryoablation; left atrium; the posterior wall of the left atrium; atrial remodeling

Outcome Measures

Primary Outcomes (1)

• Cerebral events

  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 Outcomes (4)

• Hospital mortality

  From the date of ablation until the date of death, assessed up to 5 days.

• Non-lethal events

  From the date of ablation to the date of any of the listed events, assessed up to 5 days.

• Recurrence of AF

  From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 24 months.

• Long-term mortality

  From the date of ablation until the date of death, assessed up to 24 months.

Study Arms (2)

Cryoablation

ACTIVE COMPARATOR

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

Procedure: Cryoablation

Radiofrequency ablation

ACTIVE COMPARATOR

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

Procedure: Radiofrequency ablation

Interventions

Cryoablation PROCEDURE

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

Cryoablation

Radiofrequency ablation PROCEDURE

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

Radiofrequency ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bakulev Scientific Center of Cardiovascular Surgery: lead

Study Sites (1)

Bakulev National Medical Research Center for Cardiovascular Surgery

Moscow, 121552, Russia

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Death; Atrial Fibrillation; Atrial Remodeling

Interventions

Cryosurgery; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Radiofrequency Therapy; Therapeutics

Study Officials

• Andrey Filatov

  Bakulev Scientific Center for Cardiovascular Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrey Filatov

CONTACT

+7(495) 414-77-02; agfilatov@bakulev.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A randomized double-blind controlled trial in two groups

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: June 10, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)