Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Occurrence of subclinical atrial fibrillation (atrial high rate episode)
研究概览
简要总结
This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients post pacemaker implantation. The purpose is to investigate the occurrence of device detected subclinical atrial fibrillation (atrial high rate episode) in patients post pacemaker implantation and assess long term clinical results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age: 18-80 years
- •Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation
- •Estimated percentage of atrial pacing >40% under sinus rhythm (LR≥60bpm, close hysteresis and rest rate)
- •Estimated percentage of ventricular pacing >40% under sinus rhythm (LR≥40bpm, DDD pacing, close hysteresis and rest rate)
- •Patients who are willing to sign the informed consent.
- •Patients who are willing to receive the implantation and post-operative follow-up.
排除标准
- •Persistent or permanent AF
- •Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr > 3.5 mg/dl or Ccr < 30ml/min)
- •Thyroid gland dysfunction
- •Pregnancy
- •Malignant tumor
- •Severe organic heart disease (such as moderate to severe mitral regurgitation, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)
- •Life expectancy < 12 months
- •Patients unable or unwilling to cooperate in the study procedures.
结局指标
主要结局
Occurrence of subclinical atrial fibrillation (atrial high rate episode)
时间窗: every 1 year upto 3 years after pacemaker implantation
Occurrence of subclinical atrial fibrillation (atrial high rate episode) during 36 months (3 years) post pacemaker implant
Occurrence of stroke
时间窗: every 1 year upto 3 years after pacemaker implantation
Stroke based on device detected subclinical atrial fibrillation episodes
次要结局
未报告次要终点