Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 409
- 试验地点
- 1
- 主要终点
- Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086
研究概览
简要总结
Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system.
Success of a pacing lead implant can be defined considering 3 items: ease of lead implant, lead stability and lead electrical performances.
These factors may be related to the physician experience (global implant experience, experience with a given lead), to the implant procedure (lead access, lead position, implant time, scopy time) to the lead (handling and mechanical characteristics) and to the patient (ischemic history).
Even though implant success rate is quite high with currently available leads, the weight of the different factors influencing success has never been studied systematically. The objective of the current study is then to define the predictive factors of an implant success with the CapsureFix MRI model 5086.
This lead has been selected because it has been available for a short period, so the investigators have a limited experience of it and it has a unique design which makes it conditionally safe in an MRI environment and which may be associated with specific handling characteristics.
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
- •Patient older than 18
- •Patient implanted with a fully automatic ICD and remotely followed-up,
- •Patient geographically stable and able to attend FU at investigative site
- •Patient who signed a data release authorization form,
排除标准
- •Patient whose mental or physical capacity impedes to give an informed data release authorization,
- •Patient already enrolled in a clinical study whose procedures may interfere with the results of the present study,
- •Patients in New York Heart Association (NYHA) class IV
结局指标
主要结局
Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086
时间窗: 3 months
Change of impedance will be measured during and post implant of the CapsureFix MRI Lead Model 5086
Ease of Implant
时间窗: at implant
Ease of implant as experienced by the implanting physician on maneuverability of the catheter. This was measured by a questionnaire for which each criterion was coded as Very Good, Good, Fair, Poor, Very Poor. Coding 9, 7, 5, 3, 1 was applied for each response with 9 representing Very Good. An average was calculated for each evaluation and for each probe implantation site.
Lead Stability
时间窗: 3 months
Lead stability of the Capsure Fix as measured by number of dislodgments
Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086
时间窗: 3 months
Change of pacing threshold will be measured during and post implant of the CapsureFix MRI lead model 5086
Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086
时间窗: 3 months
Change of sensing amplitude will be measured during and post implant of the CapsureFix MRI Lead Model 5086
次要结局
未报告次要终点