[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538269":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":61,"collaborators":63,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":26,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cardioneuroablation","ACTIVE_COMPARATOR","Radiofrequency catheter transmyocardial ablation of the ganglion plexuses (GP) of the atria - cardioneuroablation. The procedure is performed under local anesthesia using intracardiac catheters. Radiofrequency applications will be applied to the endocardial surface of the left and\u002For right atria in places of typical localization of the densest GPs network in order to destroy nerve fibers and ganglia: in patients with sinus bradycardia - in the left and right atria (5 places with the highest concentration of ganglia); in patients with impaired atrioventricular conduction - in the right atrium and in the left atrium (1 place in the right atrium - at the ostium of the coronary sinus; 2 places in the left atrium - opposite the ostium of the coronary sinus and opposite the Marshall ligament\u002Fvein).",[13],"Procedure: Ganglionated plexi ablation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham group","SHAM_COMPARATOR","In the control (sham) group, endocardial electrophysiological study will be performed, but patients will not know which procedure they performed (they are \"blinded\" in relation to the distribution group). The monitoring will be performed according to the same protocol as in the cardioneuroablation group. In case of recurrence of symptomatic bradycardia and\u002For (with) syncopal condition without traumatization of the patient in the control group, a transition to the cardioneuroablation group (cross-over) will be proposed. In case of disagreement, a pacemaker is implanted.",[19],"Diagnostic Test: Electrophysiological study",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Ganglionated plexi ablation","Through access in the femoral vein, a mapping or ablation-mapping catheter is inserted into the right atrium, and a three-dimensional reconstruction of the right atrium is performed using an electroanatomic mapping system. The inferior and superior vena cava, the coronary sinus are indicated.\n\nThen a transeptal puncture is performed using a transeptal introducer and a needle for transeptal puncture under fluoroscopic control. A three-dimensional reconstruction of the left atrium is performed using an electroanatomic mapping system.\n\nDuring or immediately after the creation of three-dimensional maps of both atria, areas of the typical concentration of ganglion plexuses (GP) are ablated using radiofrequency applications (30-50 Watts, 10-40 s each point). Ablated points are annotated on the three-dimensional map. GPs ablation zones are about 0.5 x 1.0 cm in size.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DIAGNOSTIC_TEST","Electrophysiological study","Through access in the femoral vein, a diagnostic catheter is inserted in the area of the coronary sinus under fluoroscopic control. The effective refractory period (ERP) of the atria will be measured according to the method adopted in clinical practice, namely: using a ten-pole diagnostic electrode installed in the coronary sinus, a series of eight electrical pulses with the same amplitude and frequency is applied to the atrial myocardium. Then the ninth pulse is applied with a gradual decrease in the time interval until the absence of an atrial myocardium response to the pulse is registered. The cycle of an additional, ninth pulse, in which the atrial myocardium did not respond to an electrical impulse, is considered an atrial ERP.",[15],[33],{"name":34,"affiliation":35,"role":36},"Evgeny Mikhaylov, Prof.","Almazov National Medical Research Centre","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Aleksandr Vakhrushev, PhD","CONTACT","+78127023749","advakhrushev@gmail.com",{"name":44,"role":40,"phone":41,"phoneExt":26,"email":45},"Evgeny Mikhaylov, PhD, Prof.","mikhaylov_en@almazovcentre.ru",[47],{"facility":35,"status":48,"city":49,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Saint Petersburg","Russia","RU",{"type":53,"coordinates":54},"Point",[55,56],30.31413,59.93863,{"lat":56,"lon":55},[59],{"name":60,"role":40,"phone":41,"phoneExt":26,"email":26},"Shlyakhto",{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[64,67,69,72,74,76,78,80,82],{"name":65,"class":66},"Meshalkin National Medical Research Center, Ministry of Health of Russian Federation","OTHER_GOV",{"name":68,"class":6},"The Federal Centre of Cardiovascular Surgery, Russia",{"name":70,"class":71},"Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare","NETWORK",{"name":73,"class":6},"City Clinical Hospital No.52 of Moscow Healthcare Department",{"name":75,"class":66},"National Medical Research Center for Therapy and Preventive Medicine",{"name":77,"class":66},"Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan",{"name":79,"class":6},"Tomsk National Research Medical Center of the Russian Academy of Sciences",{"name":81,"class":6},"Vishnevsky Center of Surgery",{"name":83,"class":66},"National Medical Research Center for Cardiology, Ministry of Health of Russian Federation","100538269","cardioneuroablation-for-bradyarrhythmia-100538269",false,"NCT06288633","Cardioneuroablation for Bradyarrhythmia","Cardioneuroablation for Bradyarrhythmia (Sinus Node and Atrioventricular Node Dysfunction): a Sham-controlled Randomised Multicentre Trial","CARDIOBOOST","Inclusion Criteria:\n\n1. Any of the following variants of bradyarrhythmia in patients aged 18-65 years:\n\n   (1.1.) Symptomatic sinus bradycardia or bradycardia due to atrioventricular blockade, including transient.\n\n   (1.2.) Severe asymptomatic sinus bradycardia with a rhythm frequency of \\\u003C30 beats\u002Fmin.\n\n   (1.3.) Transient atrioventricular block of II-III degree or permanent block of II degree.\n\n   (1.4.) Repeated fainting or pre-fainting states with a proven association with bradycardia (without injury).\n\n   (1.5.) Rhythm pauses \\>6 seconds.\n\n   In combination with the following two criteria:\n2. Positive reaction to physical activity and\u002For atropine test:\n\n   (2.1.) Increase in sinus rhythm frequency ≥25% or \\>90 beats\u002Fmin. (2.2.) The transition of atrioventricular blockade of the II-III degree to the 1st degree or complete normalization of atrioventricular conduction at the sinus rhythm.\n3. Sinus rhythm at the time of switching on\n\nExclusion Criteria:\n\n1. Anamnesis of injury during syncopation due to bradycardia, except in the case when the patient refused to implant an electrocardiostimulator for his own reasons in writing;\n2. Constant intake of antiarrhythmic drugs (for PVC, AF, etc.);\n3. The presence of an implanted pacemaker, a heart contractility modulation device, a cardioverter defibrillator;\n4. Drug-induced sinus bradycardia and\u002For atrioventricular block;\n5. Bradycardia due to electrolyte imbalance (e.g. hyperkalemia);\n6. Bradycardia due to hypothyroidism or other reversible conditions;\n7. No reaction to the administration of atropine (up to a maximum dose of 0.2 mg \u002F kg);\n8. Proven association of bradyarrhythmia with episodes of apnea\u002Fhypopnea in obstructive sleep apnea syndrome;\n9. Clinically significant coronary artery disease;\n10. Postinfarction cardiosclerosis;\n11. Hemodynamically significant congenital heart defects, including operated ones;\n12. Stroke or transient ischemic attack \\\u003C3 months;\n13. Open heart surgery in the anamnesis;\n14. Catheter interventions on coronary arteries or for cardiac arrhythmias \\\u003C3 days;\n15. Conditions after percutaneous coronary angioplasty \\\u003C3 months;\n16. Anamnesis of stable ventricular tachycardia on the background of bradycardia;\n17. Pregnancy or breastfeeding period","ALL","18 Years","65 Years",{"count":96,"type":97},106,"ESTIMATED","INTERVENTIONAL",[100],"NA","This is a multicenter prospective randomized blind controlled trial with a sham procedure group of the efficacy and safety of cardioneuroablation as a method of treating symptomatic bradycardia without a permanent pacemaker implantation",[103,104,105],"Bradycardia","Syncope","Sick Sinus Syndrome",[107,108,109,110],"bradycardia","cardioneuroablation","sinus node dysfunction","atrioventricular node dysfunction","2024-03-04",{"date":113,"type":114},"2024-03-05","ACTUAL",{"date":111,"type":114},{"date":117,"type":97},"2027-02-01",{"name":5,"class":6},1]