Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm

NCT06654401 | Recruiting

• 1 other identifier: ECPV-CSP-0723
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Atrial Fibrillation; Cardioversion; Catheter ablation; Late recurrence; Left atrial voltage; Left atrial volume

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Reverse remodeling of the left atrium and improvement of the contractility of the left ventricle

  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

  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

  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

Study Arms (2)

Radiofrequency pulmonary vein isolation in patients with previous electrical cardioversion

EXPERIMENTAL

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

Radiofrequency pulmonary vein isolation in patients without previous electrical cardioversion

ACTIVE COMPARATOR

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

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

Interventions

Transthoracic echocardiography DIAGNOSTIC_TEST

Standard assessment of the parameters of the left atrium: size, volume, volume indices

Radiofrequency pulmonary vein isolation in patients with previous electrical cardioversion; Radiofrequency pulmonary vein isolation in patients without previous electrical cardioversion

24-hour ECG Monitor DIAGNOSTIC_TEST

Assessment of cardiac arrhythmias according to 24-hour monitoring data

Radiofrequency pulmonary vein isolation in patients with previous electrical cardioversion; Radiofrequency pulmonary vein isolation in patients without previous electrical cardioversion

Electroanatomic mapping PROCEDURE

Intraoperative assessment of low voltage areas (potential fibrosis zones)

Radiofrequency pulmonary vein isolation in patients with previous electrical cardioversion; Radiofrequency pulmonary vein isolation in patients without previous electrical cardioversion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

Saint Petersburg State University Clinic

Saint Petersburg, Sankt-Peterburg, 190020, Russia

RECRUITING

Related Publications (5)

• 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.

  PMID: 36184544 BACKGROUND

• 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.

  PMID: 22882453 BACKGROUND

• 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.

  PMID: 37099677 BACKGROUND

• 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.

  PMID: 32391641 BACKGROUND

• 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.

  PMID: 29924375 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Anton A Sheremet, MD

CONTACT

+79313084398; sheremet.dr@yandex.ru

Aleksei A Filippov, MD, PhD

CONTACT

+79819553639; aleksei.filippov.chb@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director (Cardiac Surgery)

Model Details: Prospective, randomized, single-center study with 2 groups of patients (investigating and control arms)

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 23, 2024
• Study Start: November 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)