NCT07342608尚未招募不适用
Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum
MicroPort CRM0 个研究点目标入组 450 人开始时间: 2026年3月31日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 450
- 主要终点
- LINEA lead complication free rate at 3 months
研究概览
简要总结
The purpose of the clinical investigation is to evaluate the safety and performances of the new LINEA cardiac pacing lead, intended for placement at the interventricular septum.
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
- •(phase I and II):
- •Patient indicated for cardiac pacing according to the most recent guidelines from the European Society of Cardiology (ESC)
- •Patient planned for a de novo implantation of an ALIZEA, BOREA or CELEA Single Chamber (SR) or Dual Chamber (DR) pacemaker from MicroPort CRM
- •Patient planned for a catheter-guided ventricular pacing lead implantation in the interventricular septum area
- •Patient's pacemaker with the remote monitoring functions accepted by the patient and planned to be activated
排除标准
- •(phase I and II):
- •Patient planned for a device upgrade, or a device or a lead replacement
- •Patient with a congenital heart disease, hypertrophic cardiomyopathy or infiltrative cardiomyopathy
- •Patient with a Left Ventricular Ejection Fraction (LVEF) ≤ 35%
- •Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
- •Patient having a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient for whom a single dose of steroid eluted by the pacing lead (e.g., dexamethasone sodium phosphate) is contraindicated, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
- •Patient with a life expectancy of less than 2 years
- •Minor age patient (i.e. under 18 years of age)
- •Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
- •Non-menopausal women
研究组 & 干预措施
LINEA cardiac pacing lead
Experimental
干预措施: Use of LINEA cardiac pacing lead (Device)
结局指标
主要结局
LINEA lead complication free rate at 3 months
时间窗: 3 months after implantation
Proportion of patients free from complication related to the LINEA lead. A complication is defined as a SADE with a probable or causal relationship to the LINEA lead which triggered an additional invasive intervention or resulted in patient death
LINEA lead pacing threshold amplitude at 3 months
时间窗: 3 months after implantation
Mean ventricular pacing threshold amplitude
次要结局
- Success rate of LINEA lead minimum sensed amplitude(3 months after implantation)
- General performances of LINEA lead(Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation)
- Safety of the LINEA lead(Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation)
- Safety of the FLEXIGO delivery catheter and the FLEXIGO slitter(Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation)
- LINEA lead implantation success rates(Implantation)
- Lead and delivery catheter implantation time(Implantation)
- LINEA lead and FLEXIGO delivery catheter and slitter implantation usability(Implantation)
- Right Ventricular Autothreshold performances(3 months after implantation)
- Evolution of LBBAP capture over time(18 months after implantation)
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