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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 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.

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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.

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

FieldValue
Enrollment Target 35 participants
Start Date 2020-11-02
Est. Completion 2022-12-31
Phase NA

Sponsor

Abiomed

20 total trials

What the Registry Record Tells You About NCT04465201

The ClinicalTrials.gov registry entry for NCT04465201 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 53-participant average among 4 other Cardiac Output trials with a reported enrollment target (34% lower). The listed sponsor is Abiomed, which has 20 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 4 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.