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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Impella cohort | Single arm study of patients who underwent non-emergent percutaneous coronary intervention with prophylactic Impella support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic Impella support for a non-emergent PCI | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction (LVEF) | Left ventricular ejection fraction (LVEF) % | 90 days post Protective PCI (60 to 180 days window) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who meet all the inclusion criteria and none of the exclusion criteria will be enrolled in the study.
Patients in whom prophylactic hemodynamic support with Impella was used during a non-emergent PCI will be evaluated for study participation at 60 days post index PCI procedure with Impella. In this study the index procedure is designated as Impella Protected PCI (ProPCI). Patients with cardiogenic shock and/or ST elevation myocardial infarction (STEMI) at the time of Impella initiation will not be included in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Thom Dahle, MD | Saint Cloud Hospital | Study Chair |
| Jason Wollmuth, MD | Providence Health & Services | Study Chair |
| Lynn Morris, MD | East Carolina University | Study Chair |
| Craig Thompson, MD | NYU Langone | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Medical Center | Phoenix | Arizona | 85016 | United States | ||
| Tucson Medical Center |
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| 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) |
| Tucson |
| Arizona |
| 85719 |
| United States |
| Washington Regional Medical Center | Fayetteville | Arkansas | 72703 | United States |
| Arkansas Cardiology P.A. | North Little Rock | Arkansas | 72117 | United States |
| Northwest Medical Center | Springdale | Arkansas | 72764 | United States |
| Loma Linda University Medical | Loma Linda | California | 92354 | United States |
| UCSD Medical Center | San Diego | California | 92093 | United States |
| Advent Health | Daytona Beach | Florida | 32117 | United States |
| NorthShore University HealthSystem | Skokie | Illinois | 60076 | United States |
| Genesis Medical Center | Davenport | Iowa | 52803 | United States |
| Baptist Healthcare System | Lexington | Kentucky | 40503 | United States |
| Lafayette General Medical Center | Houma | Louisiana | 70360 | United States |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| St. Cloud Hospital | Saint Cloud | Minnesota | 56303 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Vidant Medical Center | Greenville | North Carolina | 28275 | United States |
| Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Presbyterian Hospital Dallas | Arlington | Texas | 76011 | United States |
| Kingwood Medical Center | Kingwood | Texas | 77339 | United States |
| Sentara Healthcare | Norfolk | Virginia | 23507 | United States |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000789 | Angina, Unstable |
| D060050 | Angina, Stable |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
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