The Smart Pump Study

NCT04465201 | Active Not Recruiting FDA Device

• 1 other identifier: VV-TMF-16540
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 6

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.

Conditions

Cardiac Output

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Subjects receiving the Impella/Impella® Hemodynamics platform

EXPERIMENTAL

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

Interventions

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.

Subjects receiving the Impella/Impella® Hemodynamics platform

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Subject presents for elective PCI
• Subject or the subject's LAR has signed the informed consent
• Subject indicated for Impella® support

You may not qualify if:

• 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

Sponsors & Collaborators

• Abiomed Inc.: lead

Study Sites (6)

Ochsner Clinical Foundation

New Orleans, Louisiana, 70121, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: July 10, 2020
• Study Start: November 2, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)