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

NCT ID: NCT05021627

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2026-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cardiac autonomic nerve modification

Group Type: EXPERIMENTAL

Cardiac autonomic nerve modification

Intervention Type: PROCEDURE

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.

Pacemaker

Group Type: ACTIVE_COMPARATOR

Pacemaker implantation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Aged 18 to 80 years old;

2. Symptomatic sinus bradycardia;

3. Not meet the class I indications for pacemaker implantation.

Exclusion Criteria

1. Structural heart disease, heart surgery history;

2. Drug-induced SB, sinus pause >2.0 s, positive atropine test, corrected sinus node recovery time (cSNRT) >525 ms;

3. Any atrial or ventricular arrhythmia, or a history of ablation procedures to treat atrial tachyarrhythmias;

4. With Significant congenital heart disease, ejection fraction was <40% measured by echocardiography;

5. Allergic to contrast media;

6. Contraindication to anticoagulation medications;

7. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);

9. Poor general health; 10.Life expectancy less than 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

The Second People's Hospital of Yuhuan City

UNKNOWN

Sponsor Role: collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xu Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Xu Liu, MD

Role: CONTACT

heartlx@sina.com

+8613052320103

Other Identifiers

Chest 18

Identifier Type: -

Identifier Source: org_study_id