Restore EF Observational Study (in High-risk PCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abiomed Inc.
- 入组人数
- 406
- 试验地点
- 21
- 主要终点
- Left ventricular ejection fraction (LVEF)
研究概览
简要总结
A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard of care prophylactic Impella support for a non-emergent percutaneous coronary intervention (PCI).
详细描述
- Hypothesis The prophylactic use of Impella 2.5 or CP heart pumps during a non-emergent PCI in hemodynamically stable patients at high-risk for periprocedural complications during the procedure is associated with a significant improvement in the patient's LVEF and clinical status (heart failure symptoms and hospital readmissions) in the intermediate-term follow-up period post-ProPCI
- Objectives The primary objective of this study is to assess the patient's LVEF at 90 days post-ProPCI (60 to 180 days window) as assessed in routine clinical practice and collected from EHR by clinical investigators.
The secondary objective of the study is to assess the potential association between the completeness of revascularization and the clinical status at 90 days post-ProPCI (60-180 days window). Clinical status includes NYHA heart failure functional class and hospital readmission. 3. Sample Size: The study will enroll more than 1,000 patients at up to 30 investigational sites with experienced Impella operators (≥ 25 cases). 4. Primary Endpoint: Subject's LVEF at 90 days post-ProPCI (60 to 180 days window) collected from the subject's EHR. 5. Secondary Endpoints:
- Completeness and extent of revascularization
- NYHA functional class at 90 days post-ProPCI (60 to 180 days window)
- Readmission at 90 days post-ProPCI (60 to 180 days window)
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
- •Age ≥ 18 years
- •Subject has previously undergone (≥ 60 days) an Impella Protected PCI (ProPCI) at a study site as identified in the Impella quality (IQ) assurance database (patients who expired or were lost to follow-up prior to opening of the follow-up study window (day 60 post Impella protected PCI) will not be included in the study
排除标准
- •Subject with cardiogenic shock at the time of Impella insertion. Cardiogenic shock defined as: systemic hypotension (systolic blood pressure (SBP) <90 mmHg or the need for inotropes/pressors to maintain a SBP >90mmHg)
- •Subject with ST elevation myocardial infarction at the time of Impella insertion.
- •Subject underwent coronary bypass surgery after the index Impella ProPCI
- •Subject underwent repeat revascularization with PCI after the index Impella ProPCI
- •Subject underwent other cardiac procedures including valve therapies (surgical or percutaneous) after the index Impella ProPCI
- •Subject underwent cardiac resynchronization therapy (CRT) initiated after the index Impella ProPCI
- •Any known medical condition with a life expectancy <6 months
结局指标
主要结局
Left ventricular ejection fraction (LVEF)
时间窗: 90 days post Protective PCI (60 to 180 days window)
Left ventricular ejection fraction (LVEF) %
次要结局
- Survival Rate(90 days post Protected PCI (60 to 180 days window))
- Readmission(90 days post Protected PCI (60 to 180 days window))
- NYHA Functional Class(90 days post Protected PCI (60 to 180 days window))