Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06253000
• Other study ID #: #4.10.11.2022
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: February 2024
• Source: Bakulev Scientific Center of Cardiovascular Surgery
• Contact: Andrey Filatov
• Phone: +7(495) 414-77-02
• Email: agfilatov[@]bakulev.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Cerebrovascular Accident
• Atrial Fibrillation
• Atrial Fibrillation Recurrent
• Death
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Bakulev National Medical Research Center for Cardiovascular Surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Bakulev Scientific Center of Cardiovascular Surgery

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hospital mortality	The number of patients who died in the hospital.	From the date of ablation until the date of death, assessed up to 5 days.
Secondary	Non-lethal events	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.
Secondary	Recurrence of AF	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.
Secondary	Long-term mortality	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.