An interventional study of Ganglionated plexi ablation and Electrophysiological study in Bradycardia, Syncope and Sick Sinus Syndrome, sponsored by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Not applicable, Interventional, and Treatment
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
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.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's planned enrollment of 106 is close to the median of 100 across 187 interventional studies indexed under Bradycardia.
Browse Bradycardia studies →Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health is the lead sponsor of 30 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Radiofrequency catheter transmyocardial ablation of the ganglion plexuses (GP) of the atria - cardioneuroablation. The procedure is performed under local anesthesia using intracardiac catheters. Radiofrequency applications will be applied to the endocardial surface of the left and/or right atria in places of typical localization of the densest GPs network in order to destroy nerve fibers and ganglia: in patients with sinus bradycardia - in the left and right atria (5 places with the highest concentration of ganglia); in patients with impaired atrioventricular conduction - in the right atrium and in the left atrium (1 place in the right atrium - at the ostium of the coronary sinus; 2 places in the left atrium - opposite the ostium of the coronary sinus and opposite the Marshall ligament/vein).
Procedure: Ganglionated plexi ablation
In the control (sham) group, endocardial electrophysiological study will be performed, but patients will not know which procedure they performed (they are "blinded" in relation to the distribution group). The monitoring will be performed according to the same protocol as in the cardioneuroablation group. In case of recurrence of symptomatic bradycardia and/or (with) syncopal condition without traumatization of the patient in the control group, a transition to the cardioneuroablation group (cross-over) will be proposed. In case of disagreement, a pacemaker is implanted.
Diagnostic Test: Electrophysiological study
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.
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.
Implantation of a permanent cardiac pacemaker
Once there is a recurrence of documented symptomatic bradycardia, a permanent pacemaker implantation is considered
Time frame: 12 months post procedure
Complications of cardioneuroablation
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
Time frame: 30 days post procedure
Presence of symptomatic or asymptomatic rhythm pauses >6 seconds
As detected by ECG monitoring
Time frame: 12 months post procedure
The presence of symptomatic or asymptomatic sinus bradycardia with an average heart rate <40 beats/min in the daytime
As detected by ECG monitoring
Time frame: 12 months post procedure
Transient or permanent atrioventricular block
As detected by ECG monitoring
Time frame: 12 months post procedure
Orthostatic hypotension and/or bradycardia during passive orthostasis test
Tilt-testing
Time frame: 12 months post procedure
Sinus tachycardia after cardioneuroablation
As detected by ECG monitoring, defined as daytime mean heart rate \>100 bpm
Time frame: 30 days post procedure
Implantation of a pacemaker by 24 months after randomization
Once there is a recurrence of documented symptomatic bradycardia, a permanent pacemaker implantation is considered
Time frame: 24 months post procedure
Started Mar 2024 (actual). Primary completion is estimated for Feb 2026, 22 months after the start.
Of 47 non-industry interventional studies with no phase under Bradycardia, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's planned 22 months is below that.
Counting every sponsor, half of 83 studies reached it within 21 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health