Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaint Petersburg State University, Russia
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Transthoracic echocardiography
Diagnostic testStandard assessment of the parameters of the left atrium: size, volume, volume indices
24-hour ECG Monitor
Diagnostic testAssessment of cardiac arrhythmias according to 24-hour monitoring data
Electroanatomic mapping
Procedure/SurgeryIntraoperative assessment of low voltage areas (potential fibrosis zones)
Treatment groups
125 Participants
are divided into 2 treatment groupsGroup A: Radiofrequency pulmonary vein isolation in patients with previous electrical cardioversionExperimental treatment 3 interventions
Group B: Radiofrequency pulmonary vein isolation in patients without previous electrical cardioversionActive comparator 3 interventions
Trial outcomes
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
Time frame
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 firstSecondary outcomes
1
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
Time frame
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 first2
Freedom from atrial fibrillation 12 months after catheter ablation
Absence of events of sustained atrial tachycardia according to 24-hour monitoring
Time frame
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 first3
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).
Time frame
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 firstSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov