Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm

Saint Petersburg State University, Russia

Status: Enrolling

Conditions: Atrial Fibrillation, Persistent; Atrial Fibrillation

Treatments: Diagnostic Test: Transthoracic echocardiography; Procedure: Electroanatomic mapping; Diagnostic Test: 24-hour ECG Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06654401

ECPV-CSP-0723

Details and patient eligibility

About

The aim of this study is to evaluate benefits of electric cardioversion in the early and long-term postoperative period in patients after radiofrequency catheter isolation of pulmonary veins. Parameters of the left atrium will be evaluated by transthoracic echocardiography and electroanatomic mapping. Preservation of the sinus rhythm will be assessed by 24-hour electrocardiographic monitoring.

The main question that is planned to be answered is:

Does a reverse remodeling of the left atrium and/or a decrease in the progression of the fibrosis zone occur after performing electrical cardioversion (and before subsequent catheter ablation) in patients with persistent and long-standing persistent atrial fibrillation (AF)? Can performed electrical cardioversion serve as a predictor of AF freedom in this group of patients?

Participants will undergo a follow-up examinations (echocardiography, ECG, 24-hour ECG monitoring) at the 3rd, 6th and 12th months after catheter ablation. Based on the results of these examinations, the recurrence rate of AF will be estimated.

Two groups of patients will include both persistent and long-standing persistent AF. Experimental group will include patients who underwent electrical cardioversion before the intervention, and active comparator group will include those patients who did not undergo it. The experimental group will be subdivided into a persistent AF patients who were successfully cardioverted in sinus rhythm and persistent AF patients who failed to restore sinus rhythm during DC at the time of catheter ablation. Analysis and comparison of subgroups will be performed.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent signed by the patient to participate in the study.
• Persistent atrial fibrillation resistant to antiarrhythmic drugs for 6 months or more
• The size of the left atrium is less than 55 mm, volume is less than 130 ml, volume index (LP) is less than 55 ml/m2

Exclusion criteria

• Reversible causes of atrial fibrillation (hyperthyroidism, pericarditis, myocarditis).
• Patients in need of myocardial revascularization and/or heart valvular disease correction.
• Any previous intervention (including MAZE surgery, thoracoscopic ablation; implanted occluder of the auricle of the left atrium.).
• Patients with severe concomitant pathology requiring correction.
• Contraindications for administration of anticoagulant therapy.
• Documented presence of a blood clot in the cavity of the left atrium or other reasons preventing the insertion of catheters into the left atrium.
• BMI of 40 or more

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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125 participants in 2 patient groups

Radiofrequency pulmonary vein isolation in patients with previous electrical cardioversion

Experimental group

Description:

Depending on the duration of atrial fibrillation and anatomic parameters of the left atrium (according to heart ultrasound), patients will undergo electric cardioversion before the primary radiofrequency catether pulmonary veins' isolation. The experimental group will be subdivided into a persistent AF patients who were successfully cardioverted in sinus rhythm and persistent AF patients who failed to restore sinus rhythm during DC at the time of catheter ablation.

Treatment:

Diagnostic Test: 24-hour ECG Monitor

Procedure: Electroanatomic mapping

Diagnostic Test: Transthoracic echocardiography

Radiofrequency pulmonary vein isolation in patients without previous electrical cardioversion

Active Comparator group

Description:

Primary interventional treatment is performed without restoration of the sinus rhythm.

Treatment:

Diagnostic Test: 24-hour ECG Monitor

Procedure: Electroanatomic mapping

Diagnostic Test: Transthoracic echocardiography