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To demonstrate that the Impella® Hemodynamic Platform (the "Study Device") is safe, and measurements obtained are as good as currently used methods. These measurements include how much pressure the heart is generating and how much blood your heart is pumping during the PCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving the Impella/Impella® Hemodynamics platform | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impella CP with Smart Assist (Circulatory Support System) | Device | Subjects will receive the Impella® with the Impella® Hemodynamics Platform prior to High risk percutaneous coronary intervention (HRPCI). Device escalation or early termination of the study will be allowed for subjects as deemed necessary by the treating physician. Subjects will be consented for follow-up through discharge from the index HRPCI admission. |
| Measure | Description | Time Frame |
|---|---|---|
| The ability to calculate and display cardiac output (CO). | Defined as the number of times a CO calibration sequence is successfully completed and the CO is displayed divided by the number of times the pinging sequence is attempted. The endpoint is a rate and therefore has no units of measure. It is the "number of times CO was successfully completed, and CO is displayed" divided by the "number of times the pinging sequence was attempted" | Through study completion, approximately 2 days |
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Inclusion Criteria:
Exclusion Criteria:
Any contraindication or inability to place an Impella® including tortuous vascular anatomy, femoral bruits or absent pedal pulses
Cardiogenic shock defined as systemic hypotension (SBP<90mmHg or the need for inotropes/vasopressors to maintain an SBP >90mmHg) plus one of the following:
Suspected systemic active infection
Suspected or known pregnancy
Known contraindication to heparin, pork, pork products, or contrast media
Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures
Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary end point.
Subject belongs to a vulnerable population [Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention](streamdown:incomplete-link)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Clinical Foundation | New Orleans | Louisiana | 70121 | United States | ||
| Brigham & Women's Hospital |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 5, 2025 | Nov 18, 2025 | 12 |
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|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Ascension St. John Hospital | Detroit | Michigan | 48236 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |