Cardiogenic ShockJenaMACSNCT04451798
Acute Impact of the Impella CP Assist Device in Pts. With Cardiogenic Shock on the Patients Hemodynamic
A study testing Impella CP microaxial pump in people with Cardiogenic Shock, run by University of Leipzig at 1 site in Germany.
Trial summary
Prospective, monocentric open-label observational study for the assessment of acute hemodynamic effects following implantation of the IMPELLA CP cardiac support device Read more about this study
- Who is it for?
- Ages 16 to 91 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Impella CP microaxial pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2016to Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 91 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: JENA Mechanical Assist Circulatory Support Trial-JENAMACS-hemodynamic
Prospective, monocentric open-label observational study for the assessment of acute hemodynamic effects following implantation of the IMPELLA CP cardiac support device
- Conditions
- Cardiogenic Shock
- Being tested
- Impella CP microaxial pump
- Keywords
- Impella
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impella CP microaxial pumpDevice
ramp test
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Impella implantation and hemodynamic measurement Receives: Device: Impella CP microaxial pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic Parameters due to PA catheterisation
Pulmonary capillary Wedge pressure in dependence of Impella pump level
Measured: Day 1
Echocardiographic Parameters of left and right heart function
LV- size in dependence of Impella pump level
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study startDec 2016
- Primary completionAug 2026
- Study completionAug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Jena University Hospital
- Responsible party
- Principal investigator, Sven Möbius-Winkler, University of Leipzig
- Investigators
- Sven Möbius-Winkler, MD, Principal investigator, Universityhospital Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451798
- Sponsor's protocol ID
- SMW 07
- Acronym
- JenaMACS
- Status last verified
- Aug 2026
- First submitted
- 1 Mar 2020
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JENA Mechanical Assist Circulatory Support Trial-JENAMACS-hemodynamic
- ClinicalTrials.gov ID
- NCT04451798
- Acronym / sponsor ID
- JenaMACS / SMW 07
- Conditions
- Cardiogenic Shock
- Keywords
- Impella
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Jena University Hospital
- Study start
- Dec 2016 (actual)
- Primary completion
- Aug 2026 (actual)
- Study completion
- Aug 2026 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, monocentric open-label observational study for the assessment of acute hemodynamic effects following implantation of the IMPELLA CP cardiac support device
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Impella CP microaxial pumpImpella implantation and hemodynamic measurement |
Who may qualify
- Ages
- 16 to 91 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Cardiogenic shock following acute MI or acute heart failure with
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impella CP microaxial pumpramp test | Device | Intervention |
Primary outcome
Hemodynamic Parameters due to PA catheterisation
Time frame: Day 1
Pulmonary capillary Wedge pressure in dependence of Impella pump level
Echocardiographic Parameters of left and right heart function
Time frame: Day 1
LV- size in dependence of Impella pump level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Cardiogenic Shock
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Möbius-Winkler, MD principal investigator
Universityhospital Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impella CP microaxial pump in people with Cardiogenic Shock, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic Parameters due to PA catheterisation (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.