NCT06654401

Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm

Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm in Patients with Persistent Atrial Fibrillation Before Radio Frequency Pulmonary Vein Isolation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Saint Petersburg State University, Russia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atrial Fibrillation
• Atrial Fibrillation, Persistent

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Transthoracic echocardiography	Standard assessment of the parameters of the left atrium: size, volume, volume indices
DIAGNOSTIC_TEST	24-hour ECG Monitor	Assessment of cardiac arrhythmias according to 24-hour monitoring data
PROCEDURE	Electroanatomic mapping	Intraoperative assessment of low voltage areas (potential fibrosis zones)

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-09-01
• Completion: 2026-01-01
• First posted: 2024-10-23
• Last updated: 2024-12-20

Locations

1 site across 1 country: Russia