Perioperative Management Evaluation in Patients With Implanted Cardiac Electronic Devices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- surgery or catheter-based procedure related (S)ADE
研究概览
简要总结
Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives.
Objective: To evaluate the peri-operative management and outcome of patients with implanted CIED undergoing non-CIED related surgery or catheter-interventional procedures in clinical routine.
Study design: bi-center, non-randomized, observational registry, retrospective data-collection, on-going prospective patient enrollment, descriptive statistics
Primary endpoint: number and type of peri-operative adverse device related events (ADE) Secondary endpoints: pre-interventional data (patient characteristics, data from CIED interrogation); peri-interventional data (type of surgery/intervention, anesthesiology techniques, any AE), postinterventional data (data from post-interventional CIED interrogation, need for reprogramming / device revision).
Inclusion criteria: implanted CIED, non-CIED related surgical or catheter-based intervention, peri-procedural CIED interrogation, age >18 years Exclusion criteria: no implanted CIED, no data from any peri-procedural CIED interrogation available
Patient enrollment: retrospectively beginning from 2008, further on-going prospective inclusion Sample size: For the observational study, there is no pre-specified sample size. Data from more than 500 patients undergoing > 700 interventions are expected.
详细描述
Background: The number of worldwide implanted cardiac electronic devices (CIED) is increasing continuously. On the other hand, the number of (more and more complex) surgical and catheter based interventions in this population is increasing as well. Recommendations for peri-operative management are often based on older data from case reports and small collectives. Data especially in particular subpopulations is limited.
Objective: The study aims to evaluate the peri-operative management and outcome of patients with implanted CIED undergoing non-CIED related surgery or catheter interventional procedures (ablation) in clinical routine. Data from the study are expected to provide evidence for recommendations improving perioperative management and device programming.
Study design: bi-center, non-randomized, observational registry, retrospective data-collection, on-going prospective patient enrollment, descriptive statistics Centers: Klinikum Fuerth (dep. for Heart and Lung disease, section for clinical electrophysiology), Klinikum Nuernberg (dep. for Heart surgery).
Patients and methods:
Primary endpoint: number and type of peri-operative adverse device related events (ADE)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •implanted CIED (e.g. pacemaker, ICD, CRT),
- •performed (non-CIED related) surgical or catheter-based procedure,
- •data from peri-procedural CIED interrogation available
- •age >18 years
排除标准
- •no implanted CIED,
- •no data from any peri-interventional CIED interrogation available
结局指标
主要结局
surgery or catheter-based procedure related (S)ADE
时间窗: 1 month post-procedural
any (S)ADE related to the surgical or catheter-based procedure
次要结局
- device: post-procedural sensing decrease(1 month post-procedural)
- device: post-procedural pacing threshold increase(1 month post-procedural)
- device: post-procedural lead impedance(1 month post-procedural)