Cardioneuroablation for Bradyarrhythmia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFederal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

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

106 Participants
are divided into 2 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