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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04451798
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Sven Möbius-Winkler, University of Jena

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

Condition or disease Intervention/treatment Phase
Cardiogenic Shock Device: Impella CP microaxial pump Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: JENA Mechanical Assist Circulatory Support Trial-JENAMACS-hemodynamic
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Intervention
Impella implantation and hemodynamic measurement
Device: Impella CP microaxial pump
ramp test




Primary Outcome Measures :
  1. Hemodynamic Parameters due to PA catheterisation [ Time Frame: Day 1 ]
    PCPW Pressure in dependence of Impella pump level

  2. Echocardiographic Parameters of left and right heart function [ Time Frame: Day 1 ]
    LV- size in dependence of Impella pump level



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 91 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451798


Contacts
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Contact: SWven Möbius-Winkler, MD 0049-3641-9324503 sven.moebius-winkler@med.uni-jena.de
Contact: Christian P Schulze, MD 0049-3641-9324103 christian.schulze@med.uni-jena.de

Locations
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Germany
University of Jena Recruiting
Jena, Germany, 07747
Contact: Sven Möbius-Winkler, MD, PhD    0049-34619324503    svne.moebius-winkler@med.uni-jena.de   
Sponsors and Collaborators
University of Leipzig
Investigators
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Principal Investigator: Sven Möbius-Winkler, MD Universityhospital Jena
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Responsible Party: Sven Möbius-Winkler, Consultant, University of Jena
ClinicalTrials.gov Identifier: NCT04451798    
Other Study ID Numbers: SMW 07
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Sven Möbius-Winkler, University of Jena:
Impella
Additional relevant MeSH terms:
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Shock, Cardiogenic
Shock
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases