[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566378":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":37,"locations":47,"responsibleParty":67,"collaborators":27,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":27,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":27,"enrollmentInfo":80,"targetDuration":27,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":50,"whyStopped":27,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Saint Petersburg State University, Russia","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14,15],"Diagnostic Test: Transthoracic echocardiography","Diagnostic Test: 24-hour ECG Monitor","Procedure: Electroanatomic mapping",{"label":17,"type":18,"description":19,"interventionNames":20},"Radiofrequency pulmonary vein isolation in patients without previous electrical cardioversion","ACTIVE_COMPARATOR","Primary interventional treatment is performed without restoration of the sinus rhythm.",[13,14,15],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DIAGNOSTIC_TEST","Transthoracic echocardiography","Standard assessment of the parameters of the left atrium: size, volume, volume indices",[9,17],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"24-hour ECG Monitor","Assessment of cardiac arrhythmias according to 24-hour monitoring data",[9,17],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"PROCEDURE","Electroanatomic mapping","Intraoperative assessment of low voltage areas (potential fibrosis zones)",[9,17],[38,43],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},"Anton A Sheremet, MD","CONTACT","+79313084398","sheremet.dr@yandex.ru",{"name":44,"role":40,"phone":45,"phoneExt":27,"email":46},"Aleksei A Filippov, MD, PhD","+79819553639","aleksei.filippov.chb@gmail.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Saint Petersburg State University Clinic","RECRUITING","Saint Petersburg","Sankt-Peterburg","190020","Russia","RU",{"type":57,"coordinates":58},"Point",[59,60],30.31413,59.93863,{"lat":60,"lon":59},[63],{"name":64,"role":40,"phone":65,"phoneExt":27,"email":66},"Sergei M Efremov, MD, PhD","+79137946090","sergefremov@mail.ru",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Shmatov Dmitry","Deputy Director (Cardiac Surgery)","100566378","electrical-cardioversion-as-a-predictor-in-postoperative-preservation-of-sinus-rhythm-100566378",false,"NCT06654401","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","Inclusion Criteria:\n\n* Informed consent signed by the patient to participate in the study.\n* Persistent atrial fibrillation resistant to antiarrhythmic drugs for 6 months or more\n* 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\u002Fm2\n\nExclusion Criteria:\n\n* Reversible causes of atrial fibrillation (hyperthyroidism, pericarditis, myocarditis).\n* Patients in need of myocardial revascularization and\u002For heart valvular disease correction.\n* Any previous intervention (including MAZE surgery, thoracoscopic ablation; implanted occluder of the auricle of the left atrium.).\n* Patients with severe concomitant pathology requiring correction.\n* Contraindications for administration of anticoagulant therapy.\n* 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.\n* BMI of 40 or more","ALL","18 Years",{"count":81,"type":82},125,"ESTIMATED","INTERVENTIONAL",[85],"NA","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.\n\nThe main question that is planned to be answered is:\n\nDoes a reverse remodeling of the left atrium and\u002For 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?\n\nParticipants 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.\n\nTwo 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.",[88,89],"Atrial Fibrillation","Atrial Fibrillation, Persistent",[88,91,92,93,94,95],"Cardioversion","Catheter ablation","Late recurrence","Left atrial voltage","Left atrial volume","2024-12-17",{"date":98,"type":99},"2024-12-20","ACTUAL",{"date":101,"type":99},"2024-11-01",{"date":103,"type":82},"2026-01-01",{"name":5,"class":6},1]