NCT05021627

Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia

A Multicenter Randomized Controlled Study of Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter randomized controlled study. By comparing patients with sinus bradycardia undergoing cardiac autonomic ganglion ablation and pacemaker therapy, and long-term follow-up to evaluate its safety and effectiveness after surgery, in order to evaluate the safety and effectiveness of cardiac autonomic ganglion ablation in the treatment of sinus bradycardia.

Conditions

• Sinus Bradycardia

Interventions

Type	Name	Description
PROCEDURE	Cardiac autonomic nerve modification	Patients with sinus bradycardia undergoing cardiac autonomic ganglion ablation. Specific anatomic ablation of the 4 major left atrial GP and aorta-superior vena cava (Ao-SVC) GP was performed. Briefly, catheter ablation was performed under the guidance of an electroanatomic mapping system (CARTO,BiosenseWebster,DiamondBar,California). After completed the electroanatomic mapping of the left atrium was complete and pulmonary vein (PV) ostia identified, presumed GP clusters were ablated 1 to 2cm outside the PV-left atrium junctions at the following sites: the left superolateral area (leftsuperior GP\[LSGP\]), the leftinfer oposterior area(left inferior GP\[LIGP\]), the right superoanterior area (rightanterior GP\[RAGP\]), the right inferoposterior area(right inferior GP\[RIGP\]), and the Ao-SVC fat pad (Ao-SVCGP), and in that sequence.
PROCEDURE	Pacemaker implantation	Patients with sinus bradycardia received pacemaker implantation. The patient lay flat on the bed, puncture the subclavian vein and insert two guide wires. Cut the skin under the guide wire to make a skin bag, and stop bleeding accurately to avoid continuous bleeding of the skin bag. The pacemaker electrode is inserted into the heart cavity by guiding the guide wire, one is placed in the ventricle and the other in the atrium, and the corresponding parameters of the electrode, such as pacing threshold, impedance, etc., are measured at the same time. If the parameters are good, fix the electrode, connect the electrode with the pacemaker, place the pacemaker in the skin bag, fix the pacemaker and electrode, suture the skin layer by layer, and the operation is completed.

Timeline

• Start date: 2021-09-01
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2021-08-25
• Last updated: 2021-08-25