European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,300
- 试验地点
- 16
- 主要终点
- CIED infections
研究概览
简要总结
University of Schleswig-Holstein Campus Kiel is sponsoring the European TauroPace Registry. This investigator-initiated local, prospective, non-interventional, multi-center study includes patients undergoing cardiac implantable electronic placement including and not limited to placement, revision with the aim to upgrade or downgrade, generator substitution, additional lead placement, revision or extraction (procedure) with adjunct TauroPace. It is planned to include a total of at least 2300 procedures (valid for safety analysis).
详细描述
This study is performed as an all-case investigation. The treatment is performed based on the SOPs (Appendix Study Protocol). The standard observation period is 3 months from the 1st treatment. Safety and effectiveness are evaluated at 3rd and 12th month. In addition, the extension observation is carried out once a year for 3 years at the longest to collect information on safety and effectiveness as long as CIED treatment continues. When the treatment ends (extraction of all hardware), observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using a unique Case Report Form (CRF) system. The duration of the study is estimated at 10 years (registry).
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
- •Use of TauroPace™ is indicated and not contra-indicated according to its current Instructions For Use (IFU)
- •Participant is eligible for a CIED related surgery procedure.
排除标准
- •Age<18years
- •Participant incapable of signing Patient Informed Consent (mentally or physically) or does not sign.
结局指标
主要结局
CIED infections
时间窗: three months
CIED infections occurring in an observation period of three months after any CIED related surgical procedure in different CIED using a regimen with surface disinfection of CIEDs and irrigation of the surgical site (pocket) with a taurolidine containing antimicrobial compound adjunct.
次要结局
- AE(3, 12 and 36 months)
- All-cause mortality(3, 12 and 36 months)
- CIED infections(36 months)
- CIED infections(12 months)
研究者
Prof. Dr. Hendrik Bonnemeier
Coordinating Investigator ETPR
University of Kiel