JENA Mechanical Assist Circulatory Support Trial-JENAMACS-hemodynamic

University of Leipzig1 site in 1 country20 target enrollmentDecember 2016

ConditionsCardiogenic Shock

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiogenic Shock
Sponsor: University of Leipzig
Enrollment: 20
Locations: 1
Primary Endpoint: Hemodynamic Parameters due to PA catheterisation
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

March 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Leipzig

Responsible Party

Principal Investigator

Sven Möbius-Winkler

Principal Investigator, Clinical Professor

University of Leipzig

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