BradycardiaCARDIOBOOSTNCT06288633
Cardioneuroablation for Bradyarrhythmia
A study testing Ganglionated plexi ablation and Electrophysiological study in people with Bradycardia and Syncope, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bradycardia, Syncope, Sick Sinus Syndrome
- What is being tested?
- Ganglionated plexi ablation and Electrophysiological study
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteRussia
- Study dates
- 4 Mar 2024to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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;
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Almazov National Medical Research Centre
Saint Petersburg
Shlyakhto, +78127023749
About this study
Official title: Cardioneuroablation for Bradyarrhythmia (Sinus Node and Atrioventricular Node Dysfunction): a Sham-controlled Randomised Multicentre 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
Read the 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.
- Conditions
- Bradycardia, Syncope, Sick Sinus Syndrome
- Being tested
- Ganglionated plexi ablation, Electrophysiological study
- Keywords
- bradycardia, cardioneuroablation, sinus node dysfunction, atrioventricular node dysfunction
- Medical subject headings
- Bradycardia, Syncope, Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganglionated plexi ablationProcedure or surgery
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.
Electrophysiological studyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Diagnostic Test: Electrophysiological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation of a permanent cardiac pacemaker
Once there is a recurrence of documented symptomatic bradycardia, a permanent pacemaker implantation is considered
Measured: 12 months post procedure
Secondary outcomes (7)
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
Measured: 30 days post procedure
Presence of symptomatic or asymptomatic rhythm pauses >6 seconds
As detected by ECG monitoring
Measured: 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
Measured: 12 months post procedure
Transient or permanent atrioventricular block
As detected by ECG monitoring
Measured: 12 months post procedure
Orthostatic hypotension and/or bradycardia during passive orthostasis test
Tilt-testing
Measured: 12 months post procedure
Sinus tachycardia after cardioneuroablation
As detected by ECG monitoring, defined as daytime mean heart rate >100 bpm
Measured: 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
Measured: 24 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start4 Mar 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Evgeny Mikhaylov, Prof., Principal investigator, Almazov National Medical Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288633
- Sponsor's protocol ID
- FNWMRC
- Acronym
- CARDIOBOOST
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioneuroablation for Bradyarrhythmia (Sinus Node and Atrioventricular Node Dysfunction): a Sham-controlled Randomised Multicentre Trial
- ClinicalTrials.gov ID
- NCT06288633
- Acronym / sponsor ID
- CARDIOBOOST / FNWMRC
- Conditions
- Bradycardia, Syncope, Sick Sinus Syndrome
- Keywords
- bradycardia, cardioneuroablation, sinus node dysfunction, atrioventricular node dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthUniversity, hospital or other
- Collaborators
- 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
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardioneuroablation | Active comparator | Procedure: Ganglionated plexi ablationRadiofrequency 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). |
| Sham group | Sham comparator | Diagnostic Test: Electrophysiological studyIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (17 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ganglionated plexi ablationThrough 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. | Procedure or surgery | Cardioneuroablation |
| Electrophysiological studyThrough 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. | Diagnostic test | Sham group |
Primary outcome
Implantation of a permanent cardiac pacemaker
Time frame: 12 months post procedure
Once there is a recurrence of documented symptomatic bradycardia, a permanent pacemaker implantation is considered
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evgeny Mikhaylov, Prof. principal investigator
Almazov National Medical Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ganglionated plexi ablation and Electrophysiological study in people with Bradycardia and Syncope, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleksandr Vakhrushev, PhD (+78127023749, advakhrushev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation of a permanent cardiac pacemaker (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.