Early Mobilization After Pacemaker Implantation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Composite endpoint of incidence of adverse events from secondary outcomes depending on the length of immobilization (early vs. late).
研究概览
简要总结
Permanent pacemaker implantation is one of the most common arrhythmological procedure. This procedure is usually accompanied by a minimum of 2-3 days hospitalization, with immobilization of patients (supine) for 16-24 hours. The optimal duration of patient´s immobilization is not determined. There is also no recommendation from individual manufacturers of pacemakers for the duration of immobilization after pacemaker implantation. The length of immobilization is based rather on the tradition established at the time of using electrodes with passive fixation. The aim of our prospective, randomized study (EMAPI) is to compare the safety of short-term (4-hours) immobilization with long-term (16-24 hours) immobilization after primary pacemaker implantation. Septal position will be used for right ventricular electrode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older.
- •Indication for permanent pacemaker implantation.
- •Mobile and compliant patient.
- •Willing and able to give written informed consent.
排除标准
- •Imobile and noncompliant patient.
- •Indication of CRT implantation.
- •Upgrade or revision of implanted devise.
- •Contraindications to pacemaker implantation.
结局指标
主要结局
Composite endpoint of incidence of adverse events from secondary outcomes depending on the length of immobilization (early vs. late).
时间窗: 6 months
Comparsion of incidence of dislodgement of atrial electrode, dislodgement of ventricular electrode in septal position, hematoma surgically treated or requiring blood transfusions, pneumothorax, pocket infection, others complications
次要结局
- Incidence of hematoma (surgically treated or requiring blood transfusions.)(6 months)
- Incidence of atrial lead dislodgement.(6 months)
- Incidence of ventricular lead dislodgement.(6 months)
- Incidence of pneumothorax.(24 hours)
- Incidence of pocket infection.(6 months)
- Incidence of others complications.(6 months)
研究者
Jiri Smid
M.D.
Charles University, Czech Republic