A Multicenter Randomized Controlled Study of Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 240
- Primary Endpoint
- Symptom score after operation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 to 80 years old;
- •Symptomatic sinus bradycardia;
- •Not meet the class I indications for pacemaker implantation.
Exclusion Criteria
- •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.
Arms & Interventions
Cardiac autonomic nerve modification
Intervention: Cardiac autonomic nerve modification (Procedure)
Pacemaker
Intervention: Pacemaker implantation (Procedure)
Outcomes
Primary Outcomes
Symptom score after operation
Time Frame: 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 Outcomes
- Quality of life score(48 months)
- Psychological quality score(48 months)
Investigators
Xu Liu
Professor
Shanghai Chest Hospital