The Smart Pump Study

Cardiac Output Clinical Trial

Official title:

Advanced Impella® SmartAssist® System for Patient Monitoring & Treatment: The Smart Pump Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04465201
• Other study ID #: VV-TMF-16540
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2022
• Source: Abiomed Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Output

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Ascension St. John Hospital	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Spectrum Health	Grand Rapids	Michigan
United States	Ochsner Clinical Foundation	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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