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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Atrial Fibrillation, Persistent
• Intervention / Treatment: Diagnostic test: Transthoracic echocardiography; Diagnostic test: 24-hour ECG Monitor; Procedure: Electroanatomic mapping

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aleksei A Filippov, MD, PhD; Phone Number: +79819553639; Email: aleksei.filippov.chb@gmail.com
• Study Contact Backup: Name: Anton A Sheremet, MD; Phone Number: +79313084398; Email: sheremet.dr@yandex.ru

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 190020
    • Recruiting
    • Saint Petersburg State University Clinic
    • Contact: Sergei M Efremov, MD, PhD; Phone Number: +79137946090; Email: sergefremov@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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)
Active Comparator: Radiofrequency pulmonary vein isolation in patients without previous electrical cardioversion; Primary interventional treatment is performed without restoration of the sinus rhythm.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from atrial fibrillation 6 months after catheter ablation	Absence of events of sustained atrial tachycardia according to 24-hour ECG monitoring	Echocardiographic assessment of the parameters of the left atrium and 24-hour ECG monitoring is performed at the time of admission to the hospital; after 3,6 and 12 months after intervention or the latest data in the event of death, whenever comes first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reverse remodeling of the left atrium and improvement of the contractility of the left ventricle	An increase in the LV ejection fraction, a decrease in the volume and size of the left atrium according to transthoracic echocardiography	Echocardiographic assessment of the parameters of the left atrium and 24-hour ECG monitoring is performed at the time of admission to the hospital; after 3,6 and 12 months after intervention or the latest data in the event of death, whenever comes first
Freedom from atrial fibrillation 12 months after catheter ablation	Absence of events of sustained atrial tachycardia according to 24-hour monitoring	Echocardiographic assessment of the parameters of the left atrium and 24-hour ECG monitoring is performed at the time of admission to the hospital; after 3,6 and 12 months after intervention or the latest data in the event of death, whenever comes first
Improving the quality of life of patients with atrial fibrillation	Assessment of the quality of life of patients with atrial fibrillation based on a questionnaire: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire - provides an overall score; plus scores for symptoms, daily activities, treatment concerns, and treatment satisfaction. Overall or subscale scores range from 0-100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).	Patients fill out questionnaires upon admission to the hospital; 3, 6 and 12 months after surgical treatment or the latest data in the event of death, whenever comes first

Collaborators and Investigators

• Sponsor: Saint Petersburg State University, Russia

Publications and helpful links

General Publications

• Kamada H, Mori K, Ueda N, Wakamiya A, Nakajima K, Kamakura T, Wada M, Ishibashi K, Yamagata K, Inoue Y, Miyamoto K, Nagase S, Noda T, Izumi C, Noguchi T, Kusano K, Aiba T. Impact of Pre-Ablation Direct Current Cardioversion for Persistent Atrial Fibrillation to Predict Recurrence of Atrial Fibrillation after Catheter Ablation. Int Heart J. 2022;63(5):828-836. doi: 10.1536/ihj.22-135.
• Kang JH, Lee DI, Kim S, Kim MN, Park YM, Ban JE, Choi JI, Lim HE, Park SW, Kim YH. Prediction of long-term outcomes of catheter ablation of persistent atrial fibrillation by parameters of preablation DC cardioversion. J Cardiovasc Electrophysiol. 2012 Nov;23(11):1165-70. doi: 10.1111/j.1540-8167.2012.02339.x. Epub 2012 Aug 8.
• Choi SH, Yu HT, Kim D, Park JW, Kim TH, Uhm JS, Joung B, Lee MH, Hwang C, Pak HN. Late recurrence of atrial fibrillation 5 years after catheter ablation: predictors and outcome. Europace. 2023 May 19;25(5):euad113. doi: 10.1093/europace/euad113.
• Hanaki Y, Machino-Ohtsuka T, Aonuma K, Komatsu Y, Machino T, Yamasaki H, Igarashi M, Sekiguchi Y, Nogami A, Ieda M. Preprocedural restoration of sinus rhythm and left atrial strain predict outcomes of catheter ablation for long-standing persistent atrial fibrillation. J Cardiovasc Electrophysiol. 2020 Jul;31(7):1709-1718. doi: 10.1111/jce.14540. Epub 2020 May 16.
• Lizewska-Springer A, Dabrowska-Kugacka A, Lewicka E, Drelich L, Krolak T, Raczak G. Echocardiographic predictors of atrial fibrillation recurrence after catheter ablation: A literature review. Cardiol J. 2020;27(6):848-856. doi: 10.5603/CJ.a2018.0067. Epub 2018 Jun 20.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Catheter ablation; Cardioversion; Late recurrence; Left atrial voltage; Left atrial volume
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: ECPV-CSP-0723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data is not planned to be shared with other parties

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No