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

University of Leipzig20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cardiogenic Shock

Interventions

Impella CP microaxial pumpDEVICE

ramp test

Eligibility

Sex: ALLMin age: 16 YearsMax age: 91 Years

Medical Language ↔ Plain English

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:

Locations (1)

University of Jena

Jena, Germany

RECRUITING

Outcomes

Primary Outcomes

Hemodynamic Parameters due to PA catheterisation

Pulmonary capillary Wedge pressure in dependence of Impella pump level

Time frame: Day 1

Echocardiographic Parameters of left and right heart function

LV- size in dependence of Impella pump level

Time frame: Day 1

Central Contacts

SWven Möbius-Winkler, MD

CONTACT

0049-3641-9324503 sven.moebius-winkler@med.uni-jena.de

Christian P Schulze, MD

CONTACT

0049-3641-9324103 christian.schulze@med.uni-jena.de

Data from ClinicalTrials.gov

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