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
Location: See location...
Intervention Type: Procedure, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Saint Petersburg State University Clinic
RECRUITING
Saint Petersburg
Contact Information
Primary
Anton A Sheremet, MD
sheremet.dr@yandex.ru
+79313084398
Backup
Aleksei A Filippov, MD, PhD
aleksei.filippov.chb@gmail.com
+79819553639
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 125
Treatments
Experimental: Radiofrequency pulmonary vein isolation in patients with previous electrical cardioversion
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.
Active_comparator: Radiofrequency pulmonary vein isolation in patients without previous electrical cardioversion
Primary interventional treatment is performed without restoration of the sinus rhythm.
Related Therapeutic Areas
Sponsors
Leads: Saint Petersburg State University, Russia

This content was sourced from clinicaltrials.gov