Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm
NCT ID: NCT06654401
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
125 participants
INTERVENTIONAL
2024-11-01
2026-01-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Transthoracic echocardiography
Standard assessment of the parameters of the left atrium: size, volume, volume indices
24-hour ECG Monitor
Assessment of cardiac arrhythmias according to 24-hour monitoring data
Electroanatomic mapping
Intraoperative assessment of low voltage areas (potential fibrosis zones)
Radiofrequency pulmonary vein isolation in patients without previous electrical cardioversion
Primary interventional treatment is performed without restoration of the sinus rhythm.
Transthoracic echocardiography
Standard assessment of the parameters of the left atrium: size, volume, volume indices
24-hour ECG Monitor
Assessment of cardiac arrhythmias according to 24-hour monitoring data
Electroanatomic mapping
Intraoperative assessment of low voltage areas (potential fibrosis zones)
Interventions
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Transthoracic echocardiography
Standard assessment of the parameters of the left atrium: size, volume, volume indices
24-hour ECG Monitor
Assessment of cardiac arrhythmias according to 24-hour monitoring data
Electroanatomic mapping
Intraoperative assessment of low voltage areas (potential fibrosis zones)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Saint Petersburg State University, Russia
OTHER
Responsible Party
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Shmatov Dmitry
Deputy Director (Cardiac Surgery)
Locations
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Saint Petersburg State University Clinic
Saint Petersburg, Sankt-Peterburg, Russia
Countries
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Central Contacts
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Facility Contacts
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Sergei M Efremov, MD, PhD
Role: primary
References
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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.
Other Identifiers
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ECPV-CSP-0723
Identifier Type: -
Identifier Source: org_study_id