NCT04156412已完成不适用
AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
University Hospital, Rouen7 个研究点 分布在 2 个国家目标入组 39 人开始时间: 2020年1月2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
- 39
- 试验地点
- 7
- 主要终点
- LV Bi-zone 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
- 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
- •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.
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 according to Modification of diet in renal disease formula (MDRD) < 30ml/mn/m²).
- •Previous failure of 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.
- •Vulnerable patient such as person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision).
- •Known pregnancy, breastfeeding or women in childbearing age without an adequate contraceptive method with a known 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 Bi-zone pacing success rate
时间窗: 30 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: 30 min
Percent of patients where the placement of the AXONE lead allows at least one LV pacing vectors matching: Pacing Threshold ≤ 3.5V/0.5ms.
次要结局
- Device or Implant testing procedure-related Adverse Events(1 month post intervention)
- Electrical performance (1)(30 min)
- Electrical performance (2)(30 min)
- AXONE Implant Efficiency (1)(30 min)
- AXONE Implant Efficiency (2)(30 min)
- AXONE Implant Efficiency (3)(30 min)
- AXONE Implant Efficiency (4)(30 min)
- LV multipoint pacing success(30 min)
研究者
研究点 (7)
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