NCT07468383

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Symptomatic Bradycardia
• Autonomic Nervous System Diseases

Interventions

Type	Name	Description
PROCEDURE	Cardioneuroablation	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.
PROCEDURE	Sham Control	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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-02-28
• Completion: 2028-07-31
• First posted: 2026-03-12
• Last updated: 2026-03-13

Locations

1 site across 1 country: China