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

JENA Mechanical Assist Circulatory Support Trial-JENAMACS-hemodynamic

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

Study Overview

• Status: Recruiting
• Conditions: Cardiogenic Shock
• Intervention / Treatment: Device: Impella CP microaxial pump

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SWven Möbius-Winkler, MD; Phone Number: 0049-3641-9324503; Email: sven.moebius-winkler@med.uni-jena.de
• Study Contact Backup: Name: Christian P Schulze, MD; Phone Number: 0049-3641-9324103; Email: christian.schulze@med.uni-jena.de

Study Locations

• Germany
  • Jena, Germany, 07747
    • Recruiting
    • University of Jena
    • Contact: Sven Möbius-Winkler, MD, PhD; Phone Number: 0049-34619324503; Email: svne.moebius-winkler@med.uni-jena.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 91 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Impella implantation and hemodynamic measurement	Device: Impella CP microaxial pump; ramp test

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Leipzig
• Collaborators: Jena University Hospital
• Investigators: Principal Investigator: Sven Möbius-Winkler, MD, Universityhospital Jena

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: March 1, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Impella
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Shock; Myocardial Infarction; Infarction; Shock, Cardiogenic
• Other Study ID Numbers: SMW 07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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