C-Pulse System eurOPean mulTicenter Study, Implantable cOuNterpulsation System in patIents With Moderate to Severe Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 8
- 主要终点
- Survival and Study Completion
研究概览
简要总结
The study is designed to observe the clinical outcomes of heart failure patients treated with C-Pulse® System in the usual manner and according to the approved indications and contraindications.
详细描述
Evaluation of the post-market clinical performance and safety of the C-Pulse® System for the treatment of Heart Failure in the population of patients who meet the approved clinical conditions provided in the indications and contraindications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 is 18 years or older
- •Patients with moderate to severe ambulatory heart failure [American College of Cardiology/American Heart Association (ACC/AHA) Stage C; NYHA Class III/IV ambulatory], who are refractory to optimal medical therapy
- •Patients who are non-responders to CRT pacemaker therapy
- •Patient has signed and dated the investigation informed consent form
排除标准
- •Evidence of significant ascending aortic calcification on postero-anterior chest X-ray or CT scan
- •Moderate or severe atherosclerotic aortic disease
- •Ascending aorto-coronary artery bypass grafts
- •Any history of aortic dissection
- •Connective tissue disorder such as Marfans disease
- •Aorta not conforming to specified dimensional constraints
- •Patient has severe mitral valve incompetence, grade 4+
- •Patient has moderate to severe aortic valve incompetence, grade 2 - 4+
- •Patient has systolic blood pressure less than 90 or greater than 140mmHg
- •Presence of active systemic infection
- •Presence of bleeding or coagulation disorder (relative)
结局指标
主要结局
Survival and Study Completion
时间窗: 5 years
Amount of participants that did not exit study for reasons including worsening heart failure resulting in hospitalization, LVAD implantation, study withdrawal or death.
KCCQ
时间窗: 6 months
Overall score from Kansas City Cardiomyopathy Questionnaire, a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status,which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. Scores range from 0-100, in which higher scores reflect better health status.
Six Minute Walk Test
时间窗: 6 months
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
INTERMACS Subject Profile/Status
时间窗: 6 months
1. Critical Cardiogenic Shock, 2. Progressive Decline, 3. Stable but Inotrope Dependent, 4. Resting Symptoms, 5. Exertion Intolerant, 6. Exertion Limited, 7. Advanced NYHA Class III, 8. NA/NYHA class I or II
NYHA Classification
时间窗: 6 Months
Participant NYHA Classification at 6 month follow up. The NYHA Classification involved 4 classes. I No limitation of physical activity II Slight limitation of physical activity III Marked limitation of physical activity IV Unable to carry on any physical activity without discomfort
次要结局
未报告次要终点