Prospective Analysis in the EMERGEncy Between TransVenous Cardiac PACIng Guided by Fluoroscopy Versus Echocardiogram
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- cardiac perforation
研究概览
简要总结
A lot of questions about use of temporary transvenous pacing still remain obscure and there is no effective comparison between use of fluoroscopy versus electrocardiogram/echocardiogram in patients with bradicardias. The aim of the study is to evaluate how long does it take to start the correct cardiac stimulation with transvenous pacing in patients with bradicardias comparing use of fluoroscopy versus electrocardiogram/echocardiogram and compare rates of complications between two methods.
详细描述
Approximately 150 subjects will be recruited over a planned recruitment period of 18 months. Patients will be submitted to ecchocardiogram using Philips Envisor, and electrocardiogram with Philips Healthcare PageWriter TC30.
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
- Single (Outcomes Assessor)
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
- •adult males and females aged > 18 years
- •symptomatic bradicardia
- •informed consent signed.
排除标准
- •pregnancy
- •hemodynamic instability (pulmonary congestion / systolic arterial pressure lower than 90 mmHg)
- •body mass index greater than 40 kg/ m2
- •use of oral anticoagulation
- •acute coronary syndromes
- •left ventricle ejection fraction < 45%
- •presence of any kind of cardiac stimulation device
结局指标
主要结局
cardiac perforation
时间窗: 1 week
Incidence of cardiac perforation assessed by a clinical diagnosis
ventricular tachycardia
时间窗: 1 week
Incidence of ventricular tachycardia assessed by an ECG test
any complication the delays definitive pacemaker > 48 hours
时间窗: 1 week
clinical diagnosis
hematoma > 5 cm
时间窗: 1 week
image
venous thrombosis
时间窗: 1 week
Incidence of venous thrombosis assessed by an ultrasound
pneumothorax
时间窗: 1 week
Incidence of pneumothorax assessed by a clinical diagnosis
infection
时间窗: 1 week
Incidence of infection assessed by a clinical diagnosis
all cause mortality
时间窗: 1 week
loss of capture
时间窗: 1 week
Incidence of loss of capture assessed by an ECG test
次要结局
- Time to start the correct cardiac stimulation with transvenous pacing(1 week)
- rates of success(1 week)