CCM Technologies OPEN HF Registry: Observational Patient EvaluatioN of CCM® Therapy for Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,500
- 试验地点
- 1
- 主要终点
- Assess CCM's effect on the rate and length of stay of heart failure (HF) hospitalizations
研究概览
简要总结
The registry has been designed to evaluate the long-term safety and efficacy of CCM therapy in a real-world setting.
详细描述
This is a global, prospective and retrospective, multicenter, single-arm, observational study intended to include patients who will receive/have received CCM therapy with an Impulse Dynamics system, including future CCM technologies (e.g. CCM-D), for a follow-up period of at least 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Patients who have /will be implanted with Impulse Dynamics CCM technologies (e.g. CCM or CCM-D when available) as determined by investigators
- •Willing and able to provide informed consent, including for use of data for research purposes (e.g. publication, sub-studies/sub-analyses)
排除标准
- •Noncompliant patients (e.g. for follow-up visits, medication, etc.) as determined by investigators.
- •Subjects with a mechanical tricuspid valve
结局指标
主要结局
Assess CCM's effect on the rate and length of stay of heart failure (HF) hospitalizations
时间窗: 1 Year
Change in the HF hospitalization / urgent HF visit rate and hospital length of stay from 1 year prior to 1 year following index implantation.
Demonstrate the long-term safety of CCM therapy in a real-world setting, by assessing the rate of device- or procedure-related complications.
时间窗: 5 Years
Rate of freedom from a composite of device- or procedure-related complication post-index implantation procedure. Serious procedure related complications occurring through the end of 30 days following the index procedure. Serious CCM device-related complications\* occurring through the end of 1-year following the index procedure. \* excluding lead-related complications
次要结局
- Assess CCM's effect on clinical outcomes(5 Years)
- Assess CCM's effect on mortality (all-cause, cardiovascular, and heart failure related)(5 Year)
- Assess CCM's effect on healthy days at home (HDAH)(3 Years)
- Assess CCM's effect on functional capacity(5 Year)
- Assess CCM's effect cardiovascular reverse remodeling(5 Year)
- Assess CCM's effect QRS duration(5 Years)
- Assess CCM's systemic effects(5 Years)
- Assess CCM clinical outcomes by subject sub-groups(5 Years)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(1 Year)
- Evaluate subject battery charging compliance(5 Year)
- Assess long-term CCM device-related adverse events and lead related events(5 Years)
- Assess the dose response of CCM therapy(5 Year)
- Assess the effect of ancillary equipment on clinical outcomes(5 Years)