Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 33
- 试验地点
- 18
- 主要终点
- Freedom from INVICTA lead-related complications
研究概览
简要总结
The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR) and PASSIVE fixation type models (single and dual coil: INVICTA 1CT, INVICTA 2CT).
详细描述
FRIENDS study is a pre-market approval (INVICTA leads - devices under investigation - are not CE marked), interventional, prospective, longitudinal, international (European), multicenter, single arm study.
The devices under investigation, the INVICTA defibrillation leads, are new quadripolar leads, to be used with Implantable Cardiac Defibrillators and Cardiac Resynchronization Therapy Defibrillators (ICD/CRT-D).
This clinical study intends to demonstrate safety and electrical performances of the INVICTA leads among the different models: active fixation either single coil (model 1CR) or dual coil (model 2CR) and passive fixation, either single coil (model 1CT) or dual coil (model 2CT) leads models. The clinical data will be used to support the application to CE marking of INVICTA leads.
The primary endpoints will be evaluated at 3 months post-implantation; secondary endpoints will be evaluated up to 2 years post-implantation.
A maximum number of 224 patients will be enrolled in the study, in up to 60 centers in Europe.
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
- •Any patient presenting an ICD or CRT-D indication as detailed in the latest European Society of Cardiology (ESC) guidelines
- •Scheduled for a primary implant of an ICD / CRT-D, manufactured by MicroPort CRM and equipped with a RV DF4 connector
- •Signed and dated informed consent
排除标准
- •Tricuspid valvular disease or tricuspid replacement heart valve (mechanical or tissue)
- •Transient tachyarrhythmias due to reversible causes (such as drug intoxication, electrolyte imbalance, sepsis, hypoxia or other factors as myocardial infarction or electric shock)
- •Contraindication to a maximum single dose of 330 µg dexamethasone sodium phosphate (DSP)
- •Active myocarditis
- •Already included in another clinical study that could confound the results of this study
- •Inability to understand the purpose of the study or to meet follow-up visits at the implanting centre as defined in the investigational plan
- •Patient less than 18 years old or under guardianship or kept in detention
- •Known pregnancy, women in breastfeeding or in childbearing age without an adequate contraceptive method
- •Drug addiction or abuse
结局指标
主要结局
Freedom from INVICTA lead-related complications
时间窗: 90 days
Freedom from INVICTA lead-related complications as assessed by an independent events adjudicator and defined as any INVICTA lead-related serious adverse device effect (SADE) that resulted in patient death or required an additional invasive intervention.
INVICTA lead electrical performance at 3 months
时间窗: 3 months
Right Ventricular (RV) pacing threshold (V) of the INVICTA lead, measured by the implanted ICD/CRT-D with 0.5 ms pulse width
次要结局
- INVICTA sensing threshold(24 months)
- INVICTA lead implant success rate(At Implant (Day 0))
- INVICTA lead pacing threshold(24 months)
- INVICTA lead impedances(24 months)
- INVICTA lead handling assessment(At Implant (Day 0))
- Percentage of the shocks that successfully terminate a ventricular arrhythmia episode(24 months)
- INVICTA lead complication free-rate up to 24 months(24 months)
- INVICTA lead-related Serious Adverse Events and device deficiencies up to 24 months(24 months)