Prospektives KÖln Bonner Register Zur Extraktion Von Schrittmacher- Und ICD-Sonden (KÖBES)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Procedural success
研究概览
简要总结
The KOBES registry is an all-comers prospective clinical registry of the cooperative Köln Bonn lead extraction center. All patients undergoing complex lead extraction procedures (i.e. indwelling leads > 6months) in the hybrid operating room with cardiothoracic standby will be included in the registry. Preoperative, intraoperative/procedural and postoperative parameters will be recorded. All patients will be asked to provide written informed consent. Data will be pseudonomyzed and entered into a data sheet. Data will be monitored by a board and evaluated independently.
详细描述
The following parameters will be included in the registry Preoperative
General:
- pacemaker / ICD indication
- Ejektionsfraktion
- previous cardiac surgery / TAVR
- specific cardiac disease: IHD, CMP (DCM, HCM, andere), Primary electrical disease if ICD:
- primary / secondary prevention concomitant disease:HTN, DM
- CRF; GFR (ml/min)
- if yes: dialysis ?
- anticoagulation / antithrombotic therapy: Ja/Nein
Indication:
- infection (local/systemic), classification
- blood culture positive/negative
- swab positive
- classification
- TEE: pos/neg
- Device malfunction
- Phlebography y/n
- Vascular access y/n
- Number of Leads and Type
- uni/bipolar / age / abandoned leads
- ICD-leads: single-/dual-coil, age / abandoned leads
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
- •All patients with a standard indication for lead extraction according to the HRS / EHRA guidelines
排除标准
- 未提供
结局指标
主要结局
Procedural success
时间窗: 1 week
Complete / partial success with combined femoral superior extraction compared to superior extraction only
次要结局
- Complications(1 year)
研究者
Frank Eberhardt
Assistant Professor
Evangelic Hospital Kalk Cologne