NCT03750058已完成不适用
AXONE -Acute : Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
University Hospital, Rouen4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年8月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- LV Multizone pacing success rate
研究概览
简要总结
Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Male or female patient aged ≥18 years old.
- •Patient presenting a CRT-P or CRT-D indication according to the latest ESC guidelines .
- •Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD).
- •Signed and dated informed consent.
- •Patient affiliated with, or beneficiary of a social security category.
排除标准
- •Class IV of NYHA (ambulatory or not).
- •Allergy to contrast media used for imaging during cardiac catheterization.
- •Severe Renal Failure (clearance of creatinine < 30ml/mn/m²).
- •Previous failure catheterization of the coronary sinus, or previous failure of left ventricular lead implantation.
- •Already included in another clinical study involving intra-cardiac active implantable device, or participation to any other clinical trial in the last 2 weeks.
- •Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision).
- •Known pregnancy, breastfeeding women or in childbearing age without an adequate contraceptive method (failure rate < 1%).
研究组 & 干预措施
Implant test procedure
Experimental
Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy
干预措施: Implant test procedure (Device)
结局指标
主要结局
LV Multizone pacing success rate
时间窗: 20 min
Percent of patients where the placement of the AXONE lead provides two distant LV pacing vectors matching Pacing Threshold ≤ 3.5V/0.5ms
LV pacing success rate
时间窗: 20 min
Percent of patients where the placement of the AXONE lead allows at least one LV pacing vector matching Pacing Threshold ≤ 3.5V/0.5ms
次要结局
- Implant testing Procedure-related Adverse Events procedure.(1 month post testing)
- Electrical performance of device (1)(20 min)
- Satisfaction of implanter(20 min)
- Electrical performance of device (2)(20 min)
- Lead Implant Efficiency(20 min)
研究者
研究点 (4)
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