Clinical trial NCT04465201: The Smart Pump Study
Official title: Advanced Impella® SmartAssist® System for Patient Monitoring & Treatment: The Smart Pump Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Output
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 heart is generating and how much blood your heart is pumping during the PCI.


Eligibility criteria: 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

Primary outcomes:
measure: The ability to calculate and display cardiac output (CO).
timeFrame: Through study completion, approximately 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Clinical Foundation
state: Louisiana
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
References: