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

University of Leipzig

Status: Enrolling

Conditions: Cardiogenic Shock

Treatments: Device: Impella CP microaxial pump

Study type: Interventional

Funder types: Other

Identifiers

NCT04451798

SMW 07

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 16 to 91 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Exclusion Criteria:

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intervention

Experimental group

Description:

Impella implantation and hemodynamic measurement

Treatment:

Device: Impella CP microaxial pump