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The Smart Pump Study
NCT04465201 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE Impella CP with Smart Assist (Circulatory Support System)
Study Locations (6)
Michigan
- Henry Ford Hospital — Detroit
- Ascension St. John Hospital — Detroit
- Spectrum Health — Grand Rapids
Louisiana
- Ochsner Clinical Foundation — New Orleans
Massachusetts
- Brigham & Women's Hospital — Boston
New York
- Columbia University Medical Center — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2020-11-02 |
| Est. Completion | 2022-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04465201
The ClinicalTrials.gov registry entry for NCT04465201 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abiomed, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cardiac Output appearing as the primary indexed condition, and to 1 intervention — of which Impella CP with Smart Assist (Circulatory Support System) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04465201 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Michigan, Louisiana, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04465201 about?
NCT04465201 is a clinical study titled "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.
What is the current status of trial NCT04465201?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 35 participants. The study started on 2020-11-02. Estimated completion is 2022-12-31.
What conditions does trial NCT04465201 study?
This clinical trial studies the following conditions: Cardiac Output. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04465201?
The interventions under investigation include: Impella CP with Smart Assist (Circulatory Support System) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04465201?
This trial is sponsored by Abiomed, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04465201 being conducted?
This trial has 6 study locations across Louisiana, Massachusetts, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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