CompletedNot Applicable

Acute Impact of the Impella CP Assist Device in Pts. With Cardiogenic Shock on the Patients Hemodynamic

Germany20 participantsStarted 2016-12

Plain-language summary

Prospective, monocentric open-label observational study for the assessment of acute hemodynamic effects following implantation of the IMPELLA CP cardiac support device

Who can participate

Age range

16 Years – 91 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial used a device called the Impella CP to support the heart during cardiogenic shock — how does this device compare to other mechanical support options that might be available to me, and is it something my care team uses?
2The trial measured hemodynamic parameters using a pulmonary artery catheter — would I need that kind of invasive monitoring as part of my treatment, and what does that involve?
3Since this study looked at both left and right heart function using echocardiography, what does my own echo show about how both sides of my heart are functioning right now?
4This trial has already completed — does my doctor know of any published results or findings from it that might be relevant to decisions about my care?
5Given that cardiogenic shock is a medical emergency, what does my doctor think is the most important immediate treatment path for me, and where would a device like the Impella CP fit into that plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hemodynamic Parameters due to PA catheterisation

Timeframe: Day 1

Echocardiographic Parameters of left and right heart function

Timeframe: Day 1

Trial details

NCT IDNCT04451798

SponsorUniversity of Leipzig

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

View on ClinicalTrials.gov More Cardiogenic Shock trials

Who can participate

Age range

16 Years – 91 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.