Bradycardia, Sick Sinus Syndrome, Syncope
Conditions
Keywords
bradycardia, cardioneuroablation, sinus node dysfunction, atrioventricular node dysfunction
Brief 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
Detailed description
Catheter ablation is a common treatment for cardiac arrhythmias. Some patients with AF ablation or AVNRT experience acceleration of sinus rhythm, the most likely cause of which is modification of autonomic tone caused by inadvertent damage to intramural autonomic ganglia and fibers. Intentional damage to these plexuses has become known as cardioneuroablation (CNA) and is currently used in patients with tachycardia-bradycardia syndrome, vegetatively caused sinus node dysfunction and atrioventricular conduction disorders, vasovagal syncopal conditions developing in a cardioinhibitory type. It is suggested that in some patients CNA may become an alternative to permanent pacemaker for the treatment of symptomatic bradyarrhythmias. This is a multicentre randomised clinical study evaluating the efficacy of cardioneuroablation for severe bradycardia due to sinus node dysfunction and/or atrioventricular nide dysfunction versus a sham procedure.
Interventions
PROCEDUREGanglionated 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_TESTElectrophysiological 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
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation
The Federal Centre of Cardiovascular Surgery, Russia
Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare
City Clinical Hospital No.52 of Moscow Healthcare Department
National Medical Research Center for Therapy and Preventive Medicine
Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan
Tomsk National Research Medical Center of the Russian Academy of Sciences
Vishnevsky Center of Surgery
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Any of the following variants of bradyarrhythmia in patients aged 18-65 years: (1.1.) Symptomatic sinus bradycardia or bradycardia due to atrioventricular blockade, including transient. (1.2.) Severe asymptomatic sinus bradycardia with a rhythm frequency of \<30 beats/min. (1.3.) Transient atrioventricular block of II-III degree or permanent block of II degree. (1.4.) Repeated fainting or pre-fainting states with a proven association with bradycardia (without injury). (1.5.) Rhythm pauses \>6 seconds. In combination with the following two criteria: 2. Positive reaction to physical activity and/or atropine test: (2.1.) Increase in sinus rhythm frequency ≥25% or \>90 beats/min. (2.2.) The transition of atrioventricular blockade of the II-III degree to the 1st degree or complete normalization of atrioventricular conduction at the sinus rhythm. 3. Sinus rhythm at the time of switching on
Exclusion criteria
1. 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; 2. Constant intake of antiarrhythmic drugs (for PVC, AF, etc.); 3. The presence of an implanted pacemaker, a heart contractility modulation device, a cardioverter defibrillator; 4. Drug-induced sinus bradycardia and/or atrioventricular block; 5. Bradycardia due to electrolyte imbalance (e.g. hyperkalemia); 6. Bradycardia due to hypothyroidism or other reversible conditions; 7. No reaction to the administration of atropine (up to a maximum dose of 0.2 mg / kg); 8. Proven association of bradyarrhythmia with episodes of apnea/hypopnea in obstructive sleep apnea syndrome; 9. Clinically significant coronary artery disease; 10. Postinfarction cardiosclerosis; 11. Hemodynamically significant congenital heart defects, including operated ones; 12. Stroke or transient ischemic attack \<3 months; 13. Open heart surgery in the anamnesis; 14. Catheter interventions on coronary arteries or for cardiac arrhythmias \<3 days; 15. Conditions after percutaneous coronary angioplasty \<3 months; 16. Anamnesis of stable ventricular tachycardia on the background of bradycardia; 17. Pregnancy or breastfeeding period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implantation of a permanent cardiac pacemaker | 12 months post procedure | Once there is a recurrence of documented symptomatic bradycardia, a permanent pacemaker implantation is considered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of symptomatic or asymptomatic rhythm pauses >6 seconds | 12 months post procedure | As detected by ECG monitoring |
| The presence of symptomatic or asymptomatic sinus bradycardia with an average heart rate <40 beats/min in the daytime | 12 months post procedure | As detected by ECG monitoring |
| Transient or permanent atrioventricular block | 12 months post procedure | As detected by ECG monitoring |
| Complications of cardioneuroablation | 30 days post procedure | Cardiac tamponade, pericardial effusion \>10 mm, esophageal damage, stroke or transient ischemic event, severe groin hematoma (hemoglobin level drop \>20%), atriovenous fistula in the groin |
| Sinus tachycardia after cardioneuroablation | 30 days post procedure | As detected by ECG monitoring, defined as daytime mean heart rate \>100 bpm |
| Implantation of a pacemaker by 24 months after randomization | 24 months post procedure | Once there is a recurrence of documented symptomatic bradycardia, a permanent pacemaker implantation is considered |
| Orthostatic hypotension and/or bradycardia during passive orthostasis test | 12 months post procedure | Tilt-testing |
Countries
Russia
Contacts
Primary ContactAleksandr Vakhrushev, PhD
Backup ContactEvgeny Mikhaylov, PhD, Prof.
Outcome results
None listed