Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Right ventricle threshold detection
研究概览
简要总结
Temporary cardiac pacing with active-fixation leads (TPAFL) using a reusable permanent pacemaker generator has been shown to be safer than lead systems without fixation. However, TPAFL requires the off-label (non-certificated) use of Pacemaker leads and generators. It is designed a fastening system to ensure the safety and efficacy of the procedure: the KronoSafe System®. The aim of this study is to demonstrate the safety and effectiveness of the KronoSafe System® for temporary pacing in a series of patients receiving TPAFL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patient older than 18 years.
- •Need for temporary cardiac stimulation
- •Temporary active fixation pacemaker implantation through left or right jugular access.
- •Signature of informed consent
- •Correct functioning of the electrode after the implantation: sensing of the R wave above 5 millivolts. Ventricular pacing threshold below 1 volt. Electrode impedance between 400-1200 Ohm.
- •Pacemaker programming with stimulation output at 5 volts intensity and 1 millisecond pulse duration.
- •Placement of the KronoSafe® fastening system after electrode implantation.
排除标准
- •Complication during the procedure: pneumothorax, hematoma at the puncture site, cardiac perforation, accidental arterial puncture or other that, in the investigator's opinion, poses an added risk of pacemaker dysfunction.
- •Need to transfer the patient to another center with loss of follow-up.
- •Absence of surveillance through continuous electrocardiographic monitoring with detection of arrhythmic events.
结局指标
主要结局
Right ventricle threshold detection
时间窗: Immediately before the procedure of lead removal
Right ventricle threshold, measured in volts with pacemaker generator programmer
Lead displacement detection
时间窗: Immediately before the procedure of lead removal
Visual observation of 2 cm electrode displacement through vein acces by clinical examination
Capture failure detection
时间窗: Immediately before the procedure of lead removal
Right ventricle threshold above 5 volts during 1 millisecond, measured with pacemaker generator programmer.
Lead insulation breakdown detection
时间窗: Immediately before the procedure of lead removal
Visual observation of lead insulation breakdown by clinical examination
Cardiac peroration detection
时间窗: Immediately before the procedure of lead removal
New pericardial effusion detected by Echocardiography with signs of cardiac tamponade: respiratory variation of transmitral filling flow greater than 25%
Ventricular R wave detection
时间窗: Immediately before the procedure of lead removal
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Lead impedance detection
时间窗: Immediately before the procedure of lead removal
Lead impedance, measured in ohms with pacemaker generator programmer
Sensing failure detection
时间窗: Immediately before the procedure of lead removal
Ventricular R wave below 1 volt, measured with pacemaker generator programmer
Generator detachment detection
时间窗: Immediately before the procedure of lead removal
Visual observation of generator detachment by clinical examination. removal of the generator from the casing.
次要结局
- Detection of Bacteremia(Immediately after the procedure of lead removal)
- Detection of Agitation(Immediately after the procedure of lead removal)