Clinical trial NCT06654401: Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm
Official title: Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm in Patients with Persistent Atrial Fibrillation Before Radio Frequency Pulmonary Vein Isolation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Atrial Fibrillation, Persistent
Keywords: Atrial Fibrillation
Cardioversion
Catheter ablation
Late recurrence
Left atrial voltage
Left atrial volume
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, single-center study with 2 groups of patients (investigating and control arms)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Freedom from atrial fibrillation 6 months after catheter ablation
timeFrame: 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:
measure: Reverse remodeling of the left atrium and improvement of the contractility of the left ventricle
timeFrame: 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
measure: Freedom from atrial fibrillation 12 months after catheter ablation
timeFrame: 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
measure: Improving the quality of life of patients with atrial fibrillation
timeFrame: 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
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State University Clinic
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.