Cardioneuroablation for Bradyarrhythmia

Official title

Cardioneuroablation for Bradyarrhythmia (Sinus Node and Atrioventricular Node Dysfunction): a Sham-controlled Randomised Multicentre Trial

Overview

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

• 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 usi
• 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

Primary outcome measures

• Implantation of a permanent cardiac pacemaker [Time frame: 12 months post procedure]

Secondary outcome measures (7)

• Complications of cardioneuroablation [Time frame: 30 days post procedure]
• Presence of symptomatic or asymptomatic rhythm pauses >6 seconds [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 [Time frame: 12 months post procedure]
• Transient or permanent atrioventricular block [Time frame: 12 months post procedure]
• Orthostatic hypotension and/or bradycardia during passive orthostasis test [Time frame: 12 months post procedure]
• Sinus tachycardia after cardioneuroablation [Time frame: 30 days post procedure]
• Implantation of a pacemaker by 24 months after randomization [Time frame: 24 months post procedure]

Eligibility criteria

Inclusion criteria

• 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.

• Sinus rhythm at the time of switching on

Exclusion criteria

• 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;
• Bradycardia due to electrolyte imbalance (e.g. hyperkalemia);
• Bradycardia due to hypothyroidism or other reversible conditions;
• No reaction to the administration of atropine (up to a maximum dose of 0.2 mg / kg);
• Proven association of bradyarrhythmia with episodes of apnea/hypopnea in obstructive sleep apnea syndrome;
• Clinically significant coronary artery disease;
• Postinfarction cardiosclerosis;
• Hemodynamically significant congenital heart defects, including operated ones;
• Stroke or transient ischemic attack <3 months;
• Open heart surgery in the anamnesis;
• Catheter interventions on coronary arteries or for cardiac arrhythmias <3 days;
• Conditions after percutaneous coronary angioplasty <3 months;
• Anamnesis of stable ventricular tachycardia on the background of bradycardia;
• Pregnancy or breastfeeding period

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Russia · 1 center

• Almazov National Medical Research Centre — Saint Petersburg

Identifiers

NCT: NCT06288633 · FNWMRC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗