Acute Impact of the Impella CP Assist Device in Pts. With Cardiogenic Shock on the Patients Hemodynamic (JenaMACS)
August 3, 2026 updated by: Sven Möbius-Winkler, University of Leipzig
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jena, Germany, 07747
- University of Jena
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 91 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Impella implantation and hemodynamic measurement
|
ramp test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemodynamic Parameters due to PA catheterisation
Time Frame: Day 1
|
Pulmonary capillary Wedge pressure in dependence of Impella pump level
|
Day 1
|
|
Echocardiographic Parameters of left and right heart function
Time Frame: Day 1
|
LV- size in dependence of Impella pump level
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sven Möbius-Winkler, MD, Universityhospital Jena
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
August 1, 2026
Study Completion (Actual)
August 1, 2026
Study Registration Dates
First Submitted
March 1, 2020
First Submitted That Met QC Criteria
June 25, 2020
First Posted (Actual)
June 30, 2020
Study Record Updates
Last Update Posted (Actual)
August 4, 2026
Last Update Submitted That Met QC Criteria
August 3, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMW 07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.