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OpenTrials
Completed

NCT Number: NCT04451798

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

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

Completed

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Key information

Conditions

Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

16 year–91 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Jena

Jena, 07747, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Impella CP microaxial pump

Device

ramp test

Primary outcomes

  1. Hemodynamic Parameters due to PA catheterisation

    Time frame: Day 1

    Pulmonary capillary Wedge pressure in dependence of Impella pump level

  2. Echocardiographic Parameters of left and right heart function

    Time frame: Day 1

    LV- size in dependence of Impella pump level

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • Jena University Hospital

Registry information

Official study title

JENA Mechanical Assist Circulatory Support Trial-JENAMACS-hemodynamic

Acronym: JenaMACS

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2020
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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