A Prospective, Multi-center, Non-randomized, Single Arm Open Label Study of 620 Subjects Receiving the OPTIMIZER Smart With CCM Therapy as Standard of Care
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 620
- 试验地点
- 88
- 主要终点
- Incidence of procedure and device-related complications
研究概览
简要总结
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45%
详细描述
The Impulse Dynamics OPTIMIZER Smart Pre-Market Application (PMA) clinical data confirmed that CCM therapy delivered with the Optimizer meaningfully improved health outcomes in patients with NYHA class III heart failure symptoms and left ventricular ejection fraction of 25-45%. CCM has shown significant improvements in quality of life measures, with an average improvement of >11 points in MLHWFQ incremental to the improvement of a randomized control group with no device. Six minute hall walk and functional class also showed improvements in the PMA data. The post-approval study (PAS) protocol has been designed to evaluate long term safety and efficacy of the OPTIMIZER Smart in a real-world setting.
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 provides written authorization and/or consent per institution and geographical requirements
- •Male or non-pregnant female, aged 18 or older
- •Left ventricular ejection fraction of 25-45% (inclusive, per site assessment)
- •NYHA Class III heart failure symptoms
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Patient has been treated with guideline-directed medical therapy
排除标准
- •Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
- •IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant
- •Myocardial infarction within 90 days prior to implant
- •Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant
- •Prior heart transplant or ventricular assist device
- •Mechanical tricuspid valve
- •Receiving cardiac resynchronization therapy (CRT) or has a Class I indication for CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy
- •Participating in a cardiac investigational 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 consent.
结局指标
主要结局
Incidence of procedure and device-related complications
时间窗: 1 year
Demonstrate, in the post-approval setting, that the OPTIMIZER Smart is safe to use, by assessing the rate of procedure related complications (30 days) and device related complications (1-year)
All-cause mortality
时间窗: 3 years
Observed mortality will be compared to the predicted mortality according to the Seattle Heart Failure Model (SHFM) at 1 year and 3 years post-implant
Procedure related complications
时间窗: 30-days
Procedure related complications through the end of 30 days following the index procedure
次要结局
- Cardiovascular hospitalizations(2 years)