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A multi-center, prospective & retrospective, observational single-arm study of the clinical outcomes up to one year collected from electronic health records of patients which have undergone standard of care implantation of Impella 5.5, regardless of clinical situation or indication. All patients will be enrolled via an IRB-approved Waiver of Informed Consent and HIPAA Authorization.
All patients who were supported retrospectively (prior to site IRB approval) with Impella 5.5 at the investigative site will be entered into the SURPASS registry and specified as the retrospective cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm all comers supported with Impella 5.5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impella 5.5 | Device | Impella 5.5 mechanical circulatory support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival Outcome | The rate of patients who survived at Impella 5.5 explant, hospital discharge and follow-up up to 1 year | One year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients 18 years old and older who previously received an Impella 5.5 implant at the study site
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| Name | Affiliation | Role |
|---|---|---|
| Masaki Funamoto, MD | Methodist San Antonio Hospital | Principal Investigator |
| Mark Anderson, MD | Hackensack Meridian Health | Principal Investigator |
| David D'Alessandro, MD | MGH | Principal Investigator |
| Gundars Katlaps, MD | Tampa General Hospital | Principal Investigator |
| Anthony Lemaire, MD | Robert Wood Johnson University Hospital | Principal Investigator |
| Edward Soltesz, MD | The Cleveland Clinic | Principal Investigator |
| Masashi Kawabori, MD | Tufts Medical Center | Principal Investigator |
| Ahmad Zeeshan, MD | Advent Health Orlando | Principal Investigator |
| Fardad Esmailian, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Advent Health Orlando |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Orlando |
| Florida |
| 302803 |
| United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| MGH | Boston | Massachusetts | 02114 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| The Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Integris Health Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15219 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Memorial Hermann Texas Medical Center | Houston | Texas | 77030 | United States |
| Methodist San Antonio Hospital | San Antonio | Texas | 78229 | United States |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |