ProspEctive Record of Safety and Electrical Performances Of XFINE Leads: an International Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 19
- 主要终点
- Freedom from XFINE lead-related complications
研究概览
简要总结
The purpose of the study is to confirm the safety and the electrical performances of the XFINE passive pacing leads, for both right ventricular (RV) straight models and right atrial (RA) J-shape models, up to 12 months follow-up post implant.
详细描述
All subjects will be followed until 12 months follow-up post implant.
At each follow-up visits (3, 6 and 12 months), electrical performances will be measured and safety will be monitored during the whole study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Any subject newly implanted according to the most recent guidelines from the European Society of Cardiology (ESC) for less than10 days with:
- •a Single Chamber (SR) or a Dual Chamber (DR) pacemaker from Microport CRM S.r.l.
- •any right atrial and/or right ventricular XFINE lead
- •Have reviewed, signed and dated the informed consent
排除标准
- •Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device
- •Contraindication to a maximum single dose of 310 µg Dexamethasone Sodium Phosphate (DSP)
- •Tricuspid valvular disease or tricuspid replacement heart valve (mechanical or tissue) only for subject with DR pacemaker
- •Active myocarditis, pocket and/or lead infection
- •Age less than 18 years old or under guardianship or kept in detention
- •Life expectancy less than 1 year
- •Known pregnancy, women breastfeeding or in childbearing age without an adequate contraceptive method
- •Be unavailable for the scheduled follow-up associated with this clinical study or refusal to cooperate
结局指标
主要结局
Freedom from XFINE lead-related complications
时间窗: at 6 months post implant
This endpoint will confirm the freedom from XFINE Lead-Related Complications (LRC) up to the 6 months post implant follow-up. The anticipated complication-free rate is 0.95, and will be compared against an a priori performance goal of 0.85. An XFINE Lead-Related Complication (LRC) is defined as any XFINE (RA and/or RV) lead-related Serious Adverse Device Effect (SADE) that resulted in subject death or required an additional invasive intervention (excluding re-programming) and occurred within 6 months post implant. This endpoint will be assessed independently for each lead model.
Electrical performances confirmation
时间窗: at 6 months post implant
This endpoint will characterize the XFINE lead performances in ensuring adequate Pacing Capture Thresholds (PCT) through 6 months post implant follow-up. The values assessed in this analysis are the PCT measured at 0.50 ms (or less) pulse width at 6 months follow-up visit. The PCT measured at 6 months will be compared against an a priori performance goal of 1.0V/0.5 ms, assuming an expected pacing threshold at 6 months of 0.8V/0.5 ms with a standard deviation of 0.5V. This endpoint will be assessed independently for each lead model.
次要结局
未报告次要终点