Status:
ACTIVE_NOT_RECRUITING
The Smart Pump Study
Lead Sponsor:
Abiomed Inc.
Conditions:
Cardiac Output
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 he...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Subject presents for elective PCI
- Subject or the subject's LAR has signed the informed consent
- Subject indicated for Impella® support
Exclusion
- 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:
- Any requirement for inotropes/vasopressors prior to arrival at the catherization lab
- Clinical evidence of end organ hypoperfusion
- Use of IABP or any other circulatory support device
- 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
Key Trial Info
Start Date :
November 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04465201
Start Date
November 2 2020
End Date
December 31 2022
Last Update
October 24 2022
Active Locations (6)
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1
Ochsner Clinical Foundation
New Orleans, Louisiana, United States, 70121
2
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
3
Henry Ford Hospital
Detroit, Michigan, United States, 48202
4
Ascension St. John Hospital
Detroit, Michigan, United States, 48236