Cardioneuroablation for Bradyarrhythmia

NARecruitingINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

March 4, 2024

Primary Completion Date

February 1, 2026

Study Completion Date

February 1, 2027

Conditions
BradycardiaSyncopeSick Sinus Syndrome
Interventions
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.~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."

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.

Trial Locations (1)

Unknown

RECRUITING

Almazov National Medical Research Centre, Saint Petersburg

All Listed Sponsors
collaborator

Meshalkin National Medical Research Center, Ministry of Health of Russian Federation

OTHER_GOV

collaborator

The Federal Centre of Cardiovascular Surgery, Russia

OTHER

collaborator

Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare

NETWORK

collaborator

City Clinical Hospital No.52 of Moscow Healthcare Department

OTHER

collaborator

National Medical Research Center for Therapy and Preventive Medicine

OTHER_GOV

collaborator

Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan

OTHER_GOV

collaborator

Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

collaborator

Vishnevsky Center of Surgery

OTHER

collaborator

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

OTHER_GOV

lead

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

OTHER