The Smart Pump Study

Abiomed

Status: Active, not recruiting

Conditions: Cardiac Output

Treatments: Device: Impella CP with Smart Assist (Circulatory Support System)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04465201

VV-TMF-16540

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years
2. Subject presents for elective PCI
3. Subject or the subject's LAR has signed the informed consent
4. Subject indicated for Impella® support

Exclusion criteria

1. Any contraindication or inability to place an Impella® including tortuous vascular anatomy, femoral bruits or absent pedal pulses

2. Cardiogenic shock defined as systemic hypotension (SBP<90mmHg or the need for inotropes/vasopressors to maintain an SBP >90mmHg) plus one of the following:

   1. Any requirement for inotropes/vasopressors prior to arrival at the catherization lab
   2. Clinical evidence of end organ hypoperfusion
   3. Use of IABP or any other circulatory support device

3. Suspected systemic active infection

4. Suspected or known pregnancy

5. Known contraindication to heparin, pork, pork products, or contrast media

6. 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

7. 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.

8. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Subjects receiving the Impella/Impella® Hemodynamics platform

Experimental group

Treatment:

Device: Impella CP with Smart Assist (Circulatory Support System)