About this trial
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
Eligibility criteria
Qualifiers
Sinus rhythm at the time of switching on
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Ganglionated plexi ablation
- Electrophysiological study
Treatment groups
Sponsors and collaborators
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