Cardiac OutputNCT04465201
The Smart Pump Study
A study testing Impella CP with Smart Assist (Circulatory Support System) in people with Cardiac Output, run by Abiomed Inc. at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output
- What is being tested?
- Impella CP with Smart Assist (Circulatory Support System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 6 sitesUnited States
- Study dates
- 2 Nov 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Subject presents for elective PCI
- Subject or the subject's LAR has signed the informed consent
- Subject indicated for Impella® support
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Henry Ford Hospital
Detroit, Michigan, 48202
Ascension St. John Hospital
Detroit, Michigan, 48236
Spectrum Health
Grand Rapids, Michigan, 49503
Ochsner Clinical Foundation
New Orleans, Louisiana, 70121
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: 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.
- Conditions
- Cardiac Output
- Being tested
- Impella CP with Smart Assist (Circulatory Support System)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving the Impella/Impella® Hemodynamics platform | Experimental | Not described Receives: Device: Impella CP with Smart Assist (Circulatory Support System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: Through study completion, approximately 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start2 Nov 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac OutputStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465201
- Sponsor's protocol ID
- VV-TMF-16540
- Status last verified
- Oct 2022
- First submitted
- 15 Jun 2020
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Impella® SmartAssist® System for Patient Monitoring & Treatment: The Smart Pump Study
- ClinicalTrials.gov ID
- NCT04465201
- Acronym / sponsor ID
- VV-TMF-16540
- Conditions
- Cardiac Output
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving the Impella/Impella® Hemodynamics platform | Experimental | Device: Impella CP with Smart Assist (Circulatory Support System) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Subject presents for elective PCI
- Subject or the subject's LAR has signed the informed consent
- Subject indicated for Impella® support
Key exclusion criteria (11 listed)
- 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:
- Suspected systemic active infection
- Suspected or known pregnancy
- Known contraindication to heparin, pork, pork products, or contrast media
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Subjects receiving the Impella/Impella® Hemodynamics platform |
Primary outcome
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"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impella CP with Smart Assist (Circulatory Support System) in people with Cardiac Output, run by Abiomed Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ability to calculate and display cardiac output (CO). (time frame: Through study completion, approximately 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.