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

NANot yet recruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

September 1, 2021

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Sinus Bradycardia
Interventions
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.

All Listed Sponsors
collaborator

Shandong University of Traditional Chinese Medicine

OTHER

collaborator

The Second People's Hospital of Yuhuan City

UNKNOWN

lead

Shanghai Chest Hospital

OTHER

NCT05021627 - Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia | Biotech Hunter | Biotech Hunter