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

Not Applicable

Recruiting

• Conditions: Cardiogenic Shock
• Interventions: Device: Impella CP microaxial pump

• Registration Number: NCT04451798
• Lead Sponsor: University of Leipzig

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2020-03-01
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01
• Primary Completion: 2022-12
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Impella CP microaxial pump	Impella implantation and hemodynamic measurement

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Jena; 🇩🇪 Jena, Germany