Cardioneuroablation for Bradyarrhythmia

NCT06288633 | Recruiting DMC

• 1 other identifier: FNWMRC
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Conditions

Bradycardia; Syncope; Sick Sinus Syndrome

Keywords

bradycardia; cardioneuroablation; sinus node dysfunction; atrioventricular node dysfunction

Outcome Measures

Primary Outcomes (1)

• Implantation of a permanent cardiac pacemaker

  Once there is a recurrence of documented symptomatic bradycardia, a permanent pacemaker implantation is considered

  12 months post procedure

Secondary Outcomes (7)

• Complications of cardioneuroablation

  30 days post procedure

• Presence of symptomatic or asymptomatic rhythm pauses >6 seconds

  12 months post procedure

• The presence of symptomatic or asymptomatic sinus bradycardia with an average heart rate <40 beats/min in the daytime

  12 months post procedure

• Transient or permanent atrioventricular block

  12 months post procedure

• Orthostatic hypotension and/or bradycardia during passive orthostasis test

  12 months post procedure

Study Arms (2)

Cardioneuroablation

ACTIVE COMPARATOR

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

Sham group

SHAM COMPARATOR

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

Interventions

Ganglionated plexi ablation PROCEDURE

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.

Cardioneuroablation

Electrophysiological study DIAGNOSTIC_TEST

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.

Sham group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health: lead
• 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

Study Sites (1)

Almazov National Medical Research Centre

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

Bradycardia; Syncope; Sick Sinus Syndrome

Interventions

Electrophysiologic Techniques, Cardiac

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Arrhythmia, Sinus; Heart Block; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Evgeny Mikhaylov, Prof.

  Almazov National Medical Research Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandr Vakhrushev, PhD

CONTACT

+78127023749; advakhrushev@gmail.com

Evgeny Mikhaylov, PhD, Prof.

CONTACT

+78127023749; mikhaylov_en@almazovcentre.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 1, 2024
• Study Start: March 4, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

RU (1)