Restore EF Observational Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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. Sample Size: The study will enroll more than 1,000 patients at up to 30 investigational sites with experienced Impella operators (≥ 25 cases). Primary Endpoint: Subject's LVEF at 90 days post-ProPCI (60 to 180 days window) collected from the subject's EHR. 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)

Official Title
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Restore EF Observational Study (in High-risk PCI)

Conditions
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Coronary Artery Disease, Unstable Angina, Angina, Stable, NSTEMI - Non-ST Segment Elevation MI

Intervention / Treatment
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* Device: Prophylactic Impella support for a non-emergent PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Impella cohort<br>Single arm study of patients who underwent non-emergent percutaneous coronary intervention with prophylactic Impella support | Device: Prophylactic Impella support for a non-emergent PCI<br>* Impella percutaneous mechanical circulatory support is placed via the femoral or axillary artery prior to a non-emergent PCI in patients at high risk for periprocedural complications including hemodynamic collapse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction (LVEF) | Left ventricular ejection fraction (LVEF) % | 90 days post Protective PCI (60 to 180 days window) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rate | Survival rate post non-emergent percutaneous coronary intervention (ProPCI) | 90 days post Protected PCI (60 to 180 days window) | 
| NYHA Functional Class | New York Heart Association (NYHA) functional class | 90 days post Protected PCI (60 to 180 days window) | 
| Readmission | Readmission post non-emergent percutaneous coronary intervention (ProPCI) | 90 days post Protected PCI (60 to 180 days window) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impella, Hemodynamic Mechanical Support, Left ventricular ejection fraction, Surgical turndown, High Risk PCI