106
Participants
Start Date
March 4, 2024
Primary Completion Date
February 1, 2026
Study Completion Date
February 1, 2027
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.~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
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.
RECRUITING
Almazov National Medical Research Centre, Saint Petersburg
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation
OTHER_GOV
The Federal Centre of Cardiovascular Surgery, Russia
OTHER
Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare
NETWORK
City Clinical Hospital No.52 of Moscow Healthcare Department
OTHER
National Medical Research Center for Therapy and Preventive Medicine
OTHER_GOV
Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan
OTHER_GOV
Tomsk National Research Medical Center of the Russian Academy of Sciences
OTHER
Vishnevsky Center of Surgery
OTHER
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
OTHER_GOV
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
OTHER