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Unloading in Heart Failure Cardiogenic Shock

NCT05064202 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2023-08-01

No results posted yet for this study

Summary

The purpose of this research study is to evaluate whether timely and aggressive temporary Mechanical Circulatory Support (tMCS) through the Impella 5.5® in patients with acute decompensated heart failure complicated by cardiogenic shock (ADHF-CS) has the potential to reduce the HF-CS related clinical events compared to the current standard of care.

Conditions

  • Cardiogenic Shock

Interventions

DEVICE

Impella 5.5

temporary Mechanical Circulatory Support (tMCS)

DRUG

Inotropes

Enoximone, Dobutamine, Dopamine, Milrinone

Sponsors & Collaborators

  • Abiomed Inc.

    collaborator INDUSTRY

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Alexander Nap, MD PhD · Amsterdam UMC, location VUmc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2027-10-01
Completion
2028-07-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05064202 on ClinicalTrials.gov