The Smart Pump Study

NCT ID: NCT04465201

Last Updated: 2022-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects receiving the Impella/Impella® Hemodynamics platform

Group Type: EXPERIMENTAL

Impella CP with Smart Assist (Circulatory Support System)

Intervention Type: 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.

Interventions

Impella CP with Smart Assist (Circulatory Support System)

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abiomed Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ochsner Clinical Foundation

New Orleans, Louisiana, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Ascension St. John Hospital

Detroit, Michigan, United States

Spectrum Health

Grand Rapids, Michigan, United States

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

VV-TMF-16540

Identifier Type: -

Identifier Source: org_study_id