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NCT04465201 · ClinicalTrials.gov registry record · NA
The Smart Pump Study
A NA study of Cardiac Output, sponsored by Abiomed.
- Active
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 6
- Study locations
NCT04465201: Active NA study of Cardiac Output, sponsored by Abiomed.
NCT04465201 is a NA study of Cardiac Output that is active but no longer recruiting, run by Abiomed. The registered enrollment target is 35 participants, below the 53-participant average among 4 other Cardiac Output trials with a reported enrollment target (34% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04465201, a NA study of Cardiac Output, is active but no longer recruiting, sponsored by Abiomed.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
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"
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 |
What the registry record for NCT04465201 still lists
NCT04465201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 53-participant average among 4 other Cardiac Output trials with a reported enrollment target (34% lower).
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.
NCT04465201 lists 6 locations in 4 states (Michigan, Louisiana, Massachusetts).
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.
What interventions are being tested in trial NCT04465201?
The interventions under investigation include: Impella CP with Smart Assist (Circulatory Support System) (DEVICE).
Who is sponsoring clinical trial NCT04465201?
This trial is sponsored by Abiomed, which has 20 total clinical trials registered on ClinicalTrials.gov.
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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