- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04465201
The Smart Pump Study
October 20, 2022 updated by: Abiomed Inc.
Advanced Impella® SmartAssist® System for Patient Monitoring & Treatment: The Smart Pump Study
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70121
- Ochsner Clinical Foundation
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham & Women's Hospital
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
Detroit, Michigan, United States, 48236
- Ascension St. John Hospital
-
Grand Rapids, Michigan, United States, 49503
- Spectrum Health
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 years
- Subject presents for elective PCI
- Subject or the subject's LAR has signed the informed consent
- Subject indicated for Impella® support
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Subjects receiving the Impella/Impella® Hemodynamics platform
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The ability to calculate and display cardiac output (CO).
Time Frame: 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"
|
Through study completion, approximately 2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2020
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
June 15, 2020
First Submitted That Met QC Criteria
July 6, 2020
First Posted (Actual)
July 10, 2020
Study Record Updates
Last Update Posted (Actual)
October 24, 2022
Last Update Submitted That Met QC Criteria
October 20, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- VV-TMF-16540
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiac Output
-
HeartBeat Technologies LTDUnknownLow Cardiac Output | High Cardiac OutputIsrael
-
Radboud University Medical CenterRecruiting
-
University Hospital, AngersTerminated
-
The University of Texas Medical Branch, GalvestonCompletedCardiac OutputUnited States
-
Université Libre de BruxellesCompleted
-
Centre Hospitalier Universitaire de BesanconUnknown
-
University of British ColumbiaCompleted
-
Cairo UniversityCompleted
-
Transonic Systems Inc.National Heart, Lung, and Blood Institute (NHLBI)Terminated
-
Transonic Systems Inc.National Heart, Lung, and Blood Institute (NHLBI)Withdrawn
Clinical Trials on Impella CP with Smart Assist (Circulatory Support System)
-
Odense University HospitalCharite University, Berlin, Germany; Hannover Medical School; Aarhus University... and other collaboratorsActive, not recruitingAcute Myocardial Infarction | Cardiogenic Shock AcuteGermany, Denmark, United Kingdom
-
Vivek ReddyAbiomed Inc.CompletedVentricular TachycardiaUnited States
-
Centre Hospitalier Universitaire de NiceCompletedClinical Radiculopathy | Myelopathy Due to a Cervical Disk DiseaseFrance