Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 92
- 试验地点
- 21
- 主要终点
- Performance co-primary endpoint, defined as LV pacing success rate at 6 months post implant
研究概览
简要总结
The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.
详细描述
This is a interventional, pivotal, prospective, single arm, open label, multicenter, international trial.
The device under investigation is the Axone system, consisting of:
- Axone 4LV: an ultrathin, lumenless, quadripolar, IS4-compatible lead designed for left ventricular pacing for cardiac resynchronization therapy (CRT).
- Axone µGuide: a dedicated, permanently implantable micro catheter designed for implantation of the Axone 4LV lead.
The primary endpoint data will be used to support CE marking of the Axone system.
The primary endpoints will be evaluated at 6 months post-implantation. Subjects will be followed-up at 6 weeks, 3 months, 6 months, 12 months post-implantation, then yearly until 4 years post-implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Indication for cardiac resynchronization therapy-defibrillator (CRT-D) device implant according to the latest ESC (European Society of Cardiology) guidelines
- •De-novo implant of a Platinium 4LV CRT-D device (or any newer 4LV CRT-D model manufactured by MicroPort CRM)
- •Reviewed, signed and dated informed consent form
排除标准
- •LV lead previous implant attempt
- •Upgrade to CRT from a previously implanted pacemaker or implantable cardioverter-defibrillator (ICD), or CRT device replacement
- •Known allergy to contrast media used for imaging during cardiac catheterization
- •Tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue)
- •Severe renal failure (creatinine clearance according to the Modification of Diet in Renal Disease (MDRD) formula < 30ml/min/m²)
- •Active myocarditis
- •Stroke, myocardial infarction or cardiac revascularization within 40 days prior to implant
- •Previous heart transplant or currently on heart transplant list
- •Life expectancy less than 1 year
- •Already included in another clinical study that could confound the results of this study
- •Pre-menopausal women / women in childbearing age, including pregnant and breastfeeding women
- •Less than 18 years old or under guardianship
- •Incapacitated subject, inability to understand the purpose of the study, or to meet follow-up visits at the implanting site as defined in the protocol
- •Diagnosis of drug addiction (substance use disorder)
结局指标
主要结局
Performance co-primary endpoint, defined as LV pacing success rate at 6 months post implant
时间窗: 6 months
LV pacing success is defined as at least one LV pacing vector with: * Pacing Threshold (PT) ≤ 3.5V at 1ms pulse width, and * No phrenic nerve stimulation at PT+2V / 1ms pulse width.
Safety co-primary endpoint, defined as Axone system related complication free rate at 6 months post implant
时间窗: 6 months
A complication is defined as any Serious Adverse Device Effect (SADE) resulting in death or requiring invasive intervention. Safety co-primary endpoint assessment will be based on independent event adjudication by a Clinical Event Committee (CEC).
次要结局
- Bizone LV pacing success rate at 6 months post implant(6 months)