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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Sinus Bradycardia

Treatments: Procedure: Cardiac autonomic nerve modification; Procedure: Pacemaker implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05021627

Chest 18

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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);

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Cardiac autonomic nerve modification

Experimental group

Treatment:

Procedure: Cardiac autonomic nerve modification

Pacemaker

Active Comparator group

Treatment:

Procedure: Pacemaker implantation