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NCT04451798 Clinical Trial

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

Cardiogenic Shock Clinical Trial

— JenaMACS  

Official title:
JENA Mechanical Assist Circulatory Support Trial-JENAMACS-hemodynamic

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04451798
Other study ID # SMW 07
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date March 2023

Study information
Verified date October 2022
Source University of Leipzig
Contact SWven Möbius-Winkler, MD
Phone 0049-3641-9324503
Email sven.moebius-winkler@med.uni-jena.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date March 2023
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 16 Years to 91 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Impella CP microaxial pump
ramp test

Locations
Country Name City State
Germany University of Jena Jena

Sponsors (2)
Lead Sponsor Collaborator
University of Leipzig Jena University Hospital

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemodynamic Parameters due to PA catheterisation Pulmonary capillary Wedge pressure in dependence of Impella pump level Day 1
Primary Echocardiographic Parameters of left and right heart function LV- size in dependence of Impella pump level Day 1
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