Heart pump auto mode tested in High-Risk procedure
NCT ID NCT07588399
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests two ways of running a temporary heart pump (Impella CP) during a high-risk procedure to open blocked heart arteries in patients with weakened heart muscle. Fifty patients will be randomly assigned to either an automatic mode that adjusts flow or a fixed lower-flow mode, with the doctor blinded to the setting. The goal is to see if the automatic mode helps complete the procedure more successfully without complications, informing a larger future trial.
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 heart pump
- What this could lead to
- If successful, this could show that an automatic pump setting helps complete high-risk heart procedures more safely, guiding larger future studies.
- What could go wrong
- This is a small, early pilot study with only 50 patients, so results may not apply broadly. The pump itself carries risks like bleeding or vessel damage.
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
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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
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * signed written informed consent * age ≥ 18 years * presentation in chronic coronary syndrome or acute coronary syndrome (STEMI ≥ 24h) * LV-EF ≤ 40 % and one of the following parameters: Last remaining artery Unprotected LM-PCI + severe RCA stenosis or CTO Unprotected LM-PCI + left dominance Unprotected LM-PCI + severe aortic stenosis Unprotected LM-PCI + severe mitral regurgitation RCA PCI + unprotected severe LM stenosis RCA PCI + proximal LAD stenosis + proximal LCx stenosis Exclusion Criteria: * no written informed consent * pregnancy * acute infection * recent ST-elevation myocardial infarction (\< 24 hours) or not normalized CK-MB enzymes
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Medical University of Vienna
Vienna, State of Vienna, 1090, Austria
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