Basic and Clinical Study of Cardiac Ganglion Catheter Ablation for the Treatment of Significant Bradycardia

NCT07468383 | Recruiting DMC

• 1 other identifier: AnzhenKS2026006
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Symptomatic Bradycardia; Autonomic Nervous System Diseases

Keywords

cardioneuroablation; Symptomatic Bradycardia; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• Postoperative Average Heart Rate by 24-Hour Ambulatory Electrocardiogram

  Average heart rate measured using 24-hour ambulatory electrocardiogram monitoring.

  Baseline, 1, 3, 6 and 12 months after ablation.

Secondary Outcomes (3)

• Heart Rate Variability

  Baseline, 12 months after ablation.

• Quality of Life Assessed by the Short Form-36 Health Survey (SF-36)

  Baseline, 12 months after ablation.

• PR Interval by 24-Hour Ambulatory Electrocardiogram

  Baseline, 1, 3, 6, and 12 months after ablation.

Study Arms (2)

Cardioneuroablation group

EXPERIMENTAL

Participants randomized to this group will undergo cardioneuroablation targeting atrial ganglionated plexi for treatment of functional bradyarrhythmia.

Procedure: Cardioneuroablation

Sham Control Group

PLACEBO COMPARATOR

Participants randomized to this group will undergo a sham procedure without transseptal puncture or catheter ablation.

Procedure: Sham Control

Interventions

Cardioneuroablation PROCEDURE

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.

Cardioneuroablation group

Sham Control PROCEDURE

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.

Sham Control 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:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China, 100029, China

RECRUITING

MeSH Terms

Conditions

Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Ning Zhou

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu He, PhD.

CONTACT

+86 138-1072-0787; theliu@139.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Arrhythmia Center (Unit 1)

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 12, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)