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

NCT05021627 | Not Yet Recruiting DMC

• 1 other identifier: Chest 18
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Symptom score after operation

  Each patient subjectively assessed his or her SB-related symptom, including dizziness, fatigue, and palpitation, on a score of 1 to 10 points (mildtosevere). The total SB-related symptom score for each patient was calculated as the sum of all scores for individual symptoms.

  48 months

Secondary Outcomes (2)

• Quality of life score

  48 months

• Psychological quality score

  48 months

Study Arms (2)

Cardiac autonomic nerve modification

EXPERIMENTAL

Procedure: Cardiac autonomic nerve modification

Pacemaker

ACTIVE COMPARATOR

Procedure: Pacemaker implantation

Interventions

Cardiac autonomic nerve modification 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.

Cardiac autonomic nerve modification

Pacemaker implantation 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.

Pacemaker

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 80 years old;
• Symptomatic sinus bradycardia;
• Not meet the class I indications for pacemaker implantation.

You may not qualify if:

• Structural heart disease, heart surgery history;
• Drug-induced SB, sinus pause \>2.0 s, positive atropine test, corrected sinus node recovery time (cSNRT) \>525 ms;
• Any atrial or ventricular arrhythmia, or a history of ablation procedures to treat atrial tachyarrhythmias;
• With Significant congenital heart disease, ejection fraction was \<40% measured by echocardiography;
• Allergic to contrast media;
• Contraindication to anticoagulation medications;
• Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
• \. Poor general health; 10.Life expectancy less than 6 months.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• Shandong University of Traditional Chinese Medicine: collaborator
• The Second People's Hospital of Yuhuan City: collaborator

Central Study Contacts

Xu Liu, MD

CONTACT

+8613052320103; heartlx@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2021
• First Posted: August 25, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 25, 2021

Record last verified: 2021-08