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
Sinus rhythm at the time of switching on
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;
Constant intake of antiarrhythmic drugs (for PVC, AF, etc.);
The presence of an implanted pacemaker, a heart contractility modulation device, a cardioverter defibrillator;
Drug-induced sinus bradycardia and/or atrioventricular block;
Parallel
Ganglionated plexi ablation
Procedure/SurgeryThrough 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. Then 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. During 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.
Electrophysiological study
Diagnostic testThrough 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.
Implantation of a permanent cardiac pacemaker
Once there is a recurrence of documented symptomatic bradycardia, a permanent pacemaker implantation is considered
Complications of cardioneuroablation
Cardiac tamponade, pericardial effusion \>10 mm, esophageal damage, stroke or transient ischemic event, severe groin hematoma (hemoglobin level drop \>20%), atriovenous fistula in the groin
Presence of symptomatic or asymptomatic rhythm pauses >6 seconds
As detected by ECG monitoring
The presence of symptomatic or asymptomatic sinus bradycardia with an average heart rate <40 beats/min in the daytime
As detected by ECG monitoring
Transient or permanent atrioventricular block
As detected by ECG monitoring
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Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Lead sponsor
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation
Collaborator
The Federal Centre of Cardiovascular Surgery, Russia
Collaborator
Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare
Collaborator
City Clinical Hospital No.52 of Moscow Healthcare Department
Collaborator
National Medical Research Center for Therapy and Preventive Medicine
Collaborator
Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan
Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences
Collaborator
Vishnevsky Center of Surgery
Collaborator
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Collaborator
