NCT05021627尚未招募不适用
A Multicenter Randomized Controlled Study of Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Symptom score after operation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 years old;
- •Symptomatic sinus bradycardia;
- •Not meet the class I indications for pacemaker implantation.
排除标准
- •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.
结局指标
主要结局
Symptom score after operation
时间窗: 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.
次要结局
- Quality of life score(48 months)
- Psychological quality score(48 months)
研究者
Xu Liu
Professor
Shanghai Chest Hospital
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