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

Not Applicable

Not yet recruiting

• Conditions: Sinus Bradycardia
• Interventions: Procedure: Pacemaker implantation; Procedure: Cardiac autonomic nerve modification

• Registration Number: NCT05021627
• Lead Sponsor: Shanghai Chest Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-15
• Study First Submitted QC: 2021-08-19
• Last Update Submitted: 2021-08-19
• Study First Posted: 2021-08-25
• Last Update Posted: 2021-08-25
• Study Start: 2021-09-01
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pacemaker	Pacemaker implantation	-
Cardiac autonomic nerve modification	Cardiac autonomic nerve modification	-

Primary Outcome Measures

Name	Time	Method
Symptom score after operation	48 months	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life score	48 months	The Medical Outcomes Study Short-Form 36 Health Survey (SF-36) was used to assess quality of life (QoL) at baseline and 12 months after ablation. The self-administration mode was strictly followed for QoL surveys. TheSF-36 assesses 8 specific QoL domains, namely physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problem, and mental health. For each subscale, scores were transformed to a scale ranging from 0 to 100, with lower scores representing a lower QoL.
Psychological quality score	48 months	The Zung Self-Rating Depression Scale is a short self administered survey to quantify the depressed status of a patient. There are 20 items on the scale that rate the four common characteristics of depression: the pervasive effect, the physiological equivalents, other disturbances, and psychomotor activities.; There are ten positively worded and ten negatively worded questions. Each question is scored on a scale of 1-4 (a little of the time, some of the time, good part of the time, most of the time).