The Smart Pump Study

Not Applicable

Active, not recruiting

• Conditions: Cardiac Output
• Interventions: Device: Impella CP with Smart Assist (Circulatory Support System)

• Registration Number: NCT04465201
• Lead Sponsor: Abiomed Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-10
• Study Start: 2020-11-02
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-20
• Last Update Posted: 2022-10-24
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects receiving the Impella/Impella® Hemodynamics platform	Impella CP with Smart Assist (Circulatory Support System)	-

Primary Outcome Measures

Name	Time	Method
The ability to calculate and display cardiac output (CO).	Through study completion, approximately 2 days	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"

Trial Locations

Locations (6)

Ochsner Clinical Foundation; 🇺🇸 New Orleans, Louisiana, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Ascension St. John Hospital; 🇺🇸 Detroit, Michigan, United States

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States