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Can a tiny heart pump Fine-Tune support for failing hearts?

NCT ID NCT04451798

Knowledge-focused Sponsor: University of Leipzig Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This study looks at how the Impella CP, a small mechanical heart pump, changes blood flow and heart function in people with cardiogenic shock—a life-threatening condition where the heart can't pump enough blood. Researchers will measure pressures inside the heart and use ultrasound to see how the heart responds at different pump speeds. The goal is to understand the device's acute effects to guide better use in critical care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Impella CP microaxial pump
What this could lead to
If successful, this could help doctors optimize the use of the Impella CP device to better support patients in cardiogenic shock.
What could go wrong
This is a small, observational study, so results may not apply broadly. The device carries risks like bleeding or vascular complications.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

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

Started

Dec 2016

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

16 to 91 years

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: * Cardiogenic shock following acute MI or acute heart failure with * systolic BP \< 90 mm Hg over \> 30 min or inotropes for support of cardiac output and BP with * signs of left heart failure and pulmonary congestion * and end-organ hypo perfusion with somnolence or cold, pale skin, or oliguria or serum lactate \>2 mmol/l Exclusion Criteria:

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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

Contacts and locations

Locations

  • University of Jena

    Jena, 07747, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.