Symptomatic BradycardiaNCT07468383
Basic and Clinical Study of Cardiac Ganglion Catheter Ablation for the Treatment of Significant Bradycardia
A study testing Cardioneuroablation in people with Symptomatic Bradycardia and Autonomic Nervous System Diseases, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
This study adopts a strategy combining basic research with clinical investigation to systematically explore the therapeutic value of cardioneuroablation in the treatment of vagally-mediated bradycardia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Symptomatic Bradycardia, Autonomic Nervous System Diseases
- What is being tested?
- Cardioneuroablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Jul 2028
- 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
- Age range: 18 - 65 years old
- Have symptoms related to bradycardia (syncope, dizziness, blackout, palpitations, fatigue, listlessness, inability to concentrate and decreased activity endurance, etc.)
- Meet one of the following conditions: ①Dynamic electrocardiogram shows an average heart rate of less than 50 beats per minute or there is a heart arrest lasting more than 3 seconds during the day; ②Transient second or third degree atrioventricular conduction block without hemodynamic disorders during the day
- The atropine test showed that the sinus heart rate increased by ≥ 25%, or the heart rate was ≥ 90 beats per minute, or the atrioventricular conduction block was significantly improved to be no more than first-degree atrioventricular conduction block.
Who cannot join
- A history of severe trauma caused by bradycardia
- Regular use of antiarrhythmic drugs within the past 3 months
- Prior implantation of a cardiac pacemaker
- Existing implantation of, or indication for implantation of, electronic devices with pacing function, such as cardiac contractility modulators (CCMs), implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization therapy (CRT) devices
- Bradycardia or atrioventricular block caused by medications or other reversible factors (e.g., hyperkalemia, hypothyroidism)
- Bradycardia or atrioventricular block associated with obstructive sleep apnea syndrome (OSAS)
Show all 18Show fewer
- Coronary revascularization within the past 3 months, or unstable coronary heart disease despite standardized medical treatment or revascularization
- Stroke or transient ischemic attack (TIA) within the past 3 months
- A history of open-heart surgery
- Severe congenital heart disease
- Complicated with severe ventricular arrhythmia
- Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) ≤ 35%
- Severe cardiomyopathy, such as hypertrophic obstructive cardiomyopathy (HOCM), dilated cardiomyopathy (DCM), or cardiac amyloidosis
- Severe aortic or mitral valve stenosis
- Pregnancy or lactation period
- Expected survival time of less than 1 year
- Refusal to sign the informed consent form
- Other conditions deemed ineligible by the researchers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, China, 100029
Liu He, PhD., +86 138-1072-0787, theliu@139.com
Ning Zhou, Prof.
About this study
This study adopts a strategy combining basic research with clinical investigation to systematically explore the therapeutic value of cardioneuroablation in the treatment of vagally-mediated bradycardia. The study design fully considers the complexity of the scientific question and the feasibility of clinical translation. Through rigorous experimental design and standardized operational procedures, the reliability and reproducibility of the study results are ensured.
Read the detailed description
In recent years, cardiac ganglionated plexus (GP) ablation has emerged as a novel minimally invasive electrophysiological intervention. By targeting and ablating overactive GPs, this technique aims to suppress aberrant vagal signaling and alleviate symptoms of bradycardia. It offers distinct advantages, including a mechanism-targeted approach and the avoidance of permanent device implantation. Previous studies have demonstrated the feasibility and clinical potential of this technique in patients with vasovagal syncope, particularly the cardioinhibitory type. Therefore, developing such a "device-free" interventional therapy addresses a pressing clinical need and holds significant medical importance. Results from preliminary small-scale clinical studies suggest that GP ablation can significantly reduce syncope recurrence, improve quality of life, and increase resting heart rate. However, higher-level evidence regarding the efficacy and safety of cardiac GP ablation for the treatment of symptomatic bradycardia is still lacking. Consequently, this study combines basic and clinical research to address the unresolved questions regarding cardioneuroablation, aiming to fill this evidence gap and establish an evidence-based therapeutic strategy for patients with significant, vagally-mediated bradycardia.
- Being tested
- Cardioneuroablation, Sham Control
- Keywords
- cardioneuroablation, Symptomatic Bradycardia, Efficacy, Safety
- Medical subject headings
- Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioneuroablationProcedure or surgery
The procedure is performed under local anesthesia with conventional sedation using 1-3 mg of midazolam. The decision to administer additional sedation is assessed based on the patient's level of consciousness. The femoral vein is punctured, and a sheath is placed. Through this femoral venous sheath, catheters are advanced via the right atrium to position electrodes in the coronary sinus and the right ventricle. Under the guidance of intracardiac echocardiography and fluoroscopy (X-ray), a transseptal puncture is performed. The ablation catheter is then introduced into the left atrium through the transseptal sheath to sequentially perform catheter ablation of the left atrial and, selectively, the right atrial ganglionated plexi.
Sham ControlProcedure or surgery
Throughout the procedure, the patient continuously wears over-ear headphones playing music and an eye mask. The surgery is performed under local anesthesia with conventional sedation using 1-3 mg of midazolam. The decision to administer additional sedation is assessed based on the patient's level of consciousness. Preoperative preparation, femoral vein puncture, placement of electrode catheters, and the electrophysiological study protocol are the same as in the intervention group; however, no transseptal puncture, ganglion mapping, or catheter ablation is performed.
| Study group | Role | What they receive |
|---|---|---|
| Cardioneuroablation group | Experimental | Participants randomized to this group will undergo cardioneuroablation targeting atrial ganglionated plexi for treatment of functional bradyarrhythmia. Receives: Procedure: Cardioneuroablation |
| Sham Control Group | Placebo comparator | Participants randomized to this group will undergo a sham procedure without transseptal puncture or catheter ablation. Receives: Procedure: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Average Heart Rate by 24-Hour Ambulatory Electrocardiogram
Average heart rate measured using 24-hour ambulatory electrocardiogram monitoring.
Measured: Baseline, 1, 3, 6 and 12 months after ablation.
Secondary outcomes (3)
Heart Rate Variability
Autonomic Nervous Function Testing
Measured: Baseline, 12 months after ablation.
Quality of Life Assessed by the Short Form-36 Health Survey (SF-36)
The Short Form-36 Health Survey (SF-36) is a validated questionnaire measuring health-related quality of life. Scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline, 12 months after ablation.
PR Interval by 24-Hour Ambulatory Electrocardiogram
PR interval measured using 24-hour ambulatory electrocardiogram monitoring.
Measured: Baseline, 1, 3, 6, and 12 months after ablation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Aug 2025
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic BradycardiaStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NingZhou, Beijing Anzhen Hospital
- Investigators
- Ning Zhou, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468383
- Sponsor's protocol ID
- AnzhenKS2026006
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basic and Clinical Study of Cardiac Ganglion Catheter Ablation for the Treatment of Significant Bradycardia
- ClinicalTrials.gov ID
- NCT07468383
- Acronym / sponsor ID
- AnzhenKS2026006
- Keywords
- cardioneuroablation, Symptomatic Bradycardia, Efficacy, Safety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 12 Mar 2026 (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 study adopts a strategy combining basic research with clinical investigation to systematically explore the therapeutic value of cardioneuroablation in the treatment of vagally-mediated bradycardia. The study design fully considers the complexity of the scientific question and the feasibility of clinical translation. Through rigorous experimental design and standardized operational procedures, the reliability and reproducibility of the study results are ensured.
Detailed description
In recent years, cardiac ganglionated plexus (GP) ablation has emerged as a novel minimally invasive electrophysiological intervention. By targeting and ablating overactive GPs, this technique aims to suppress aberrant vagal signaling and alleviate symptoms of bradycardia. It offers distinct advantages, including a mechanism-targeted approach and the avoidance of permanent device implantation. Previous studies have demonstrated the feasibility and clinical potential of this technique in patients with vasovagal syncope, particularly the cardioinhibitory type. Therefore, developing such a "device-free" interventional therapy addresses a pressing clinical need and holds significant medical importance. Results from preliminary small-scale clinical studies suggest that GP ablation can significantly reduce syncope recurrence, improve quality of life, and increase resting heart rate. However, higher-level evidence regarding the efficacy and safety of cardiac GP ablation for the treatment of symptomatic bradycardia is still lacking. Consequently, this study combines basic and clinical research to address the unresolved questions regarding cardioneuroablation, aiming to fill this evidence gap and establish an evidence-based therapeutic strategy for patients with significant, vagally-mediated bradycardia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardioneuroablation group | Experimental | Procedure: CardioneuroablationParticipants randomized to this group will undergo cardioneuroablation targeting atrial ganglionated plexi for treatment of functional bradyarrhythmia. |
| Sham Control Group | Placebo comparator | Procedure: Sham ControlParticipants randomized to this group will undergo a sham procedure without transseptal puncture or catheter ablation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age range: 18 - 65 years old
- Have symptoms related to bradycardia (syncope, dizziness, blackout, palpitations, fatigue, listlessness, inability to concentrate and decreased activity endurance, etc.)
- Meet one of the following conditions: ①Dynamic electrocardiogram shows an average heart rate of less than 50 beats per minute or there is a heart arrest lasting more than 3 seconds during the day; ②Transient second or third degree atrioventricular conduction block without hemodynamic disorders during the day
- The atropine test showed that the sinus heart rate increased by ≥ 25%, or the heart rate was ≥ 90 beats per minute, or the atrioventricular conduction block was significantly improved to be no more than first-degree atrioventricular conduction block.
Key exclusion criteria (18 listed)
- A history of severe trauma caused by bradycardia
- Regular use of antiarrhythmic drugs within the past 3 months
- Prior implantation of a cardiac pacemaker
- Existing implantation of, or indication for implantation of, electronic devices with pacing function, such as cardiac contractility modulators (CCMs), implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization therapy (CRT) devices
- Bradycardia or atrioventricular block caused by medications or other reversible factors (e.g., hyperkalemia, hypothyroidism)
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 |
|---|---|---|
| CardioneuroablationThe procedure is performed under local anesthesia with conventional sedation using 1-3 mg of midazolam. The decision to administer additional sedation is assessed based on the patient's level of consciousness. The femoral vein is punctured, and a sheath is placed. Through this femoral venous sheath, catheters are advanced via the right atrium to position electrodes in the coronary sinus and the right ventricle. Under the guidance of intracardiac echocardiography and fluoroscopy (X-ray), a transseptal puncture is performed. The ablation catheter is then introduced into the left atrium through the transseptal sheath to sequentially perform catheter ablation of the left atrial and, selectively, the right atrial ganglionated plexi. | Procedure or surgery | Cardioneuroablation group |
| Sham ControlThroughout the procedure, the patient continuously wears over-ear headphones playing music and an eye mask. The surgery is performed under local anesthesia with conventional sedation using 1-3 mg of midazolam. The decision to administer additional sedation is assessed based on the patient's level of consciousness. Preoperative preparation, femoral vein puncture, placement of electrode catheters, and the electrophysiological study protocol are the same as in the intervention group; however, no transseptal puncture, ganglion mapping, or catheter ablation is performed. | Procedure or surgery | Sham Control Group |
Primary outcome
Postoperative Average Heart Rate by 24-Hour Ambulatory Electrocardiogram
Time frame: Baseline, 1, 3, 6 and 12 months after ablation.
Average heart rate measured using 24-hour ambulatory electrocardiogram monitoring.
3 secondary outcomes
Heart Rate Variability
Time frame: Baseline, 12 months after ablation.
Quality of Life Assessed by the Short Form-36 Health Survey (SF-36)
Time frame: Baseline, 12 months after ablation.
PR Interval by 24-Hour Ambulatory Electrocardiogram
Time frame: Baseline, 1, 3, 6, and 12 months after ablation.
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 13 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Symptomatic Bradycardia
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Symptomatic Bradycardia, Cognitive Function
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Pacing Characteristics of a Conventional Bipolar
Symptomatic Bradycardia
RecruitingObservational study
POLish Registry of CArdioneuroablation and CArdioneuromodulation
Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS
RecruitingObservational study
Cardioneuroablation for Recurrent Vasovagal Syncope and Bradyarrhythmias: The CNA-FWRD Registry
Vasovagal Syncope, AV Block-2Nd Degree-Type 1
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Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker for Symptomatic Bradycardia.
Bradycardia, Syncope
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.
Ning Zhou principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardioneuroablation in people with Symptomatic Bradycardia and Autonomic Nervous System Diseases, run by Beijing Anzhen Hospital at 1 site in China.
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 4 inclusion and 18 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 13 Mar 2026. 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 China. 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 Liu He, PhD. (+86 138-1072-0787, theliu@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Average Heart Rate by 24-Hour Ambulatory Electrocardiogram (time frame: Baseline, 1, 3, 6 and 12 months after ablation.). 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 13 Mar 2026.