Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 317
- 试验地点
- 76
- 主要终点
- LV lead Performance at 10 weeks
研究概览
简要总结
The primary objective of this study is to assess the safety and electrical performance of Left ventricular (LV) NAVIGO 4LV leads, pre-shaped (S-shaped&U-shaped: NAVIGO 4LV 2D, NAVIGO 4LV ARC) and Straight (NAVIGO 4LV PILOT), with IS4 connector
详细描述
The devices under investigation, NAVIGO 4LV models Pilot, 2D , and ARC are the new quadripolar coronary venous leads with polyurethane lead body, intended to be used with defibrillators with ventricular resynchronization therapy.
The new lead design with the presence of 4 electrodes that allows several combinations in programming pacing vectors, is intended to benefit both the patients by improving response to therapy, overcoming high pacing threshold and avoiding phrenic nerve stimulation, and the investigators by reducing the number of re-interventions needed.
This clinical investigation is a pre-market release study intended to analyze safety and electrical performance of NAVIGO 4LV leads pre-shaped (S-shaped & U-shaped) and Straight leads models. The primary endpoint data will be used to support the achievement of the CE mark of NAVIGO 4LV leads.
The primary endpoints will be evaluated at 1 month post-implantation; secondary endpoints will be evaluated up to 2 years post-implantation. The duration of patient inclusion will be approximately 10 months for pre-shaped NAVIGO family (S-shaped &U-shaped) and approximately 21 months for straight ones.
The post implant follows-up visits will take place at Hospital discharge, weeks 10, 6 months and every 6 months until 2 years.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient presenting a CRT-D indication as detailed in the ESC guidelines
- •Primary implant of a PLATINIUM 4LV CRTD or upgrade from an existing ICD connected to a RV lead with a DF4 connector (DF4LLHH) to a PLATINIUM 4LV CRT-D
- •Signed and dated informed consent
排除标准
- •Patients for whom a maximum single dose of 300 µg dexamethasone sodium phosphate (DSP) eluted from the NAVIGO 4LV lead maybe contraindicated
- •Venous anomalies precluding transvenous implant (contraindication of a Pacemaker or ICD implant)
- •Active myocarditis, pocket and/or lead infection
- •Stroke/myocardiaI infarction one month prior to implant
- •Already included in another clinical study that could confound the results of this study.
- •Inability to meet Follow-up visits at the implanting centre as defined in the investigational plan.
- •Patient less than 18 years old or under guardianship
- •Known pregnancy, women in lactation period or in childbearing age without an adequate contraceptive method (failure rate < 1%)
- •Drug addiction or abuse
研究组 & 干预措施
NAVIGO 4LV implant
All patients will be attempted to implant or implanted with NAVIGO 4LV lead
干预措施: NAVIGO 4LV lead implant (Device)
结局指标
主要结局
LV lead Performance at 10 weeks
时间窗: 10 weeks after implant
Successful performance defined as LV pacing threshold at 10 weeks \< 2.5 V/0.5 ms observed on at least one pacing vector and absence of phrenic nerve stimulation at programmed pacing amplitude
LV lead Safety at 10 weeks
时间窗: 10 weeks after implant
Freedom from LV lead-related complications, defined as any investigational device deficiency or any serious adverse device event (SADE) that resulted in patient death or required a re-intervention (not including re-programming) that occurred within 30 days after successful implant of the CRT-D system
次要结局
- Electrical performance(through study completion, an average of 6 month)
- Rate of patients free from LV lead-related complications(through study completion, an average of 6 month)
- NAVIGO 4LV lead implant success rate on enrolled population(Enrollment)
- Number of patients with at least 2 pacing vectors with pacing threshold < 2.5 V at 0.5 ms and no phrenic nerve stimulation(10 weeks)
- LV lead-related SAEs(through study completion, an average of 6 month)
- Lead handing assessment of NAVIGO 4LV leads through a questionnaire(Implant)
- Number of patients with MP pacing activated(through study completion, an average of 6 month)
- Rationale to activate MP(through study completion, an average of 6 month)
- Number of patients with of at least one MP configuration with no phrenic nerve stimulation at programmed pacing amplitude(through study completion, an average of 6 month)
- Number of patients at each final programmed pacing vector and changes(through study completion, an average of 6 month)