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Heart pump data study aims to sharpen shock monitoring

NCT ID NCT06308055

Knowledge-focused Sponsor: Abiomed Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study gathers detailed, real-time information from the Impella heart pump and standard hospital monitors in 125 people with cardiogenic shock. The goal is to better understand how the pump and the body's vital signs work together. No new treatment is being tested; instead, researchers are collecting data to improve future care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients requiring cardiac Impella pump-support and intensive care therapy including cardiac output monitoring, eg. by pulmonary artery catheter at some point of therapy. Initially, a collection of 250 patient days is aimed for. It is expected that each patient will be monitored by PAC for at least 48 hours, thus approximately 125 patients will be needed to achieve study objectives.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Ongoing or planned intensive care management with Impella support 2. Presence or planned placement of a cardiac output measurement 1. Preferentially pulmonary catheter (including cardiac output (CO) preferred as continuous measurement) 2. Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods Exclusion Criteria: 1. Age \< 18 years 2. Pregnancy 3. Anticipated support duration \<24 h

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Conditions

The condition(s) this trial relates to.

cardiogenic shock Shock, Cardiogenic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiogenic shock

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS Ospedale San Raffaele

    NOT_YET_RECRUITING

    Milan, MI, 20132, Italy

  • UKSH Campus Kiel

    NOT_YET_RECRUITING

    Kiel, Schleswig-Holstein, 24105, Germany

  • Uniklinik RWTH Aachen

    ACTIVE_NOT_RECRUITING

    Aachen, North Rhine-Westphalia, 52074, Germany

  • Universitätsspital Basel

    RECRUITING

    Basel, Switzerland

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