Cardioneuroablation for Bradyarrhythmia

Summary

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

Conditions

• Bradycardia
• Syncope
• Sick 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.

Sponsors & Collaborators

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

  collaborator OTHER_GOV

• The Federal Centre of Cardiovascular Surgery, Russia

  collaborator OTHER

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

  collaborator NETWORK

• City Clinical Hospital No.52 of Moscow Healthcare Department

  collaborator OTHER

• National Medical Research Center for Therapy and Preventive Medicine

  collaborator OTHER_GOV

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

  collaborator OTHER_GOV

• Tomsk National Research Medical Center of the Russian Academy of Sciences

  collaborator OTHER

• Vishnevsky Center of Surgery

  collaborator OTHER

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

  collaborator OTHER_GOV

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

  lead OTHER

Principal Investigators

• Evgeny Mikhaylov, Prof. · Almazov National Medical Research Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-04

Primary Completion

2026-02-01

Completion

2027-02-01

Countries

• Russia

Study Locations