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

Primary Purpose

Cardiogenic Shock

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Impella CP microaxial pump
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiogenic Shock focused on measuring Impella

Eligibility Criteria

16 Years - 91 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • University of JenaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Impella implantation and hemodynamic measurement

Outcomes

Primary Outcome Measures

Hemodynamic Parameters due to PA catheterisation
Pulmonary capillary Wedge pressure in dependence of Impella pump level
Echocardiographic Parameters of left and right heart function
LV- size in dependence of Impella pump level

Secondary Outcome Measures

Full Information

First Posted
March 1, 2020
Last Updated
October 31, 2022
Sponsor
University of Leipzig
Collaborators
Jena University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04451798
Brief Title
Acute Impact of the Impella CP Assist Device in Pts. With Cardiogenic Shock on the Patients Hemodynamic
Acronym
JenaMACS
Official Title
JENA Mechanical Assist Circulatory Support Trial-JENAMACS-hemodynamic
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
Collaborators
Jena University Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock
Keywords
Impella

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Impella implantation and hemodynamic measurement
Intervention Type
Device
Intervention Name(s)
Impella CP microaxial pump
Intervention Description
ramp test
Primary Outcome Measure Information:
Title
Hemodynamic Parameters due to PA catheterisation
Description
Pulmonary capillary Wedge pressure in dependence of Impella pump level
Time Frame
Day 1
Title
Echocardiographic Parameters of left and right heart function
Description
LV- size in dependence of Impella pump level
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
91 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SWven Möbius-Winkler, MD
Phone
0049-3641-9324503
Email
sven.moebius-winkler@med.uni-jena.de
First Name & Middle Initial & Last Name or Official Title & Degree
Christian P Schulze, MD
Phone
0049-3641-9324103
Email
christian.schulze@med.uni-jena.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Möbius-Winkler, MD
Organizational Affiliation
Universityhospital Jena
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven Möbius-Winkler, MD, PhD
Phone
0049-34619324503
Email
svne.moebius-winkler@med.uni-jena.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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