Clinical Investigation of the ODOCOR II CCM™ Leads in Patients With Optimizer System Implant
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 40
- 主要终点
- Primary Safety endpoint
研究概览
简要总结
The objective of the ODOCOR II CCM lead study is to evaluate the safety and useability of the ODOCOR II intra-cardiac lead specifically intended to deliver CCM as an accessory lead to the Optimizer IPG.
详细描述
Design A prospective, multi-center, single arm open label study, 12-month study of 400 ODOCOR II CCM™ leads in 200 subjects .
Method Subjects shall be enrolled that have been diagnosed with NYHA Class III-IV heart failure and left ventricular ejection fraction (25-45% inclusive). Eligible subjects will receive the Optimizer IPG device implant with 2 ODOCOR II CCM leads. Subjects will return for follow-up visits at 2-weeks, 6 months and 12 months following the device implant.
Endpoints Primary Safety endpoint
The primary safety endpoint is the incidence of lead-related complication free rate at 12 months post-index implantation procedure compared to the incidence previously described in the literature for pacing therapy leads.
Secondary Safety endpoint
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patient signed and dated informed consent form
- •Male or non-pregnant female, aged 18 or older
- •Left ventricular ejection fraction of 25-45% (inclusive)
- •Diagnosed with NYHA Class III or IV heart failure
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Medically stable and with no significant mental illness in the judgement of the principal investigator
排除标准
- •Infiltrative or inflammatory cardiomyopathy (e.g. amyloid, hemochromatosis, myocarditis, hypertrophic cardiomyopathy, Fabry's disease, cardiac tumor)
- •Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 3 months of the baseline testing visit.
- •IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days before the baseline testing visit, including continuous IV inotrope therapy
- •Myocardial infarction within 3 months of the baseline testing visit.
- •Undergone a CABG procedure within 3 months90 days or a PTCA procedure within 30 days of the baseline testing visit.
- •Undergone a cardiac ablation procedure within 90 days prior to consent.
- •Prior heart transplant or ventricular assist device
- •Mechanical tricuspid valve
- •Receiving cardiac resynchronization therapy (CRT) or indicated for Class I CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy
- •Currently on dialysis
- •Currently undergoing active chemotherapeutic and/or radiation treatment for cancer
- •Participating in another cardiac investigational device study at the same time
- •Patient is in a vulnerable population (such as significant mental disability, prisoner) that in the judgement of the PI impedes ability to provide informed content.
- •Expected lifespan of less than 12 months from time the baseline testing visit.
- •Resting heart rate >110 bpm at the time of the baseline testing visit
- •Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- •Subjects currently admitted to the hospital with a primary diagnosis of heart failure
结局指标
主要结局
Primary Safety endpoint
时间窗: 12 months
The primary safety endpoint is the incidence of lead-related complication free rate at 12 months post-index implantation procedure compared to the incidence previously described in the literature for pacing therapy leads.
Primary Efficacy endpoint
时间窗: 12 month
The total amount of CCM delivered to the cardiac tissue of the right ventricle (measured by CCM percentage) will be measured over a period of 12 months.
次要结局
- Secondary Safety endpoint(12 month)
- Secondary Efficacy endpoint(12 month)