NCT04451798

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

6 years

First QC Date

March 1, 2020

Last Update Submit

October 31, 2022

Conditions

Cardiogenic Shock

Keywords

Impella

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Intervention

EXPERIMENTAL

Impella implantation and hemodynamic measurement

Device: Impella CP microaxial pump

Interventions

Impella CP microaxial pumpDEVICE

ramp test

Intervention

Eligibility Criteria

Age16 Years - 91 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jena

Jena, 07747, Germany

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Sven Möbius-Winkler, MD

    Universityhospital Jena

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SWven Möbius-Winkler, MD

CONTACT

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

Christian P Schulze, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

March 1, 2020

First Posted

June 30, 2020

Study Start

December 1, 2016

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)