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OPTIMIZE 5.5 - Optimizing Impella 5.5 Outcomes Through Advanced Data Science

NCT07619144 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-06-01

No results posted yet for this study

Summary

The main goal of this observational, study is to develop a clinical decision support tool utilizing Impella 5.5 pump parameters to predict native heart recovery and prevent adverse events, by leveraging data science and real-world clinical data of cardiogenic shock patients.

Therefore, secondary objectives are essential to consolidating a retrospective longitudinal analysis of Impella 5.5 pump data alongside ICU digital health record datasets to:

1. Validate the Impella 5.5 placement signal by comparing it with ICU arterial line waveforms.
2. Integrate pump data with ICU clinical data to identify patterns associated with therapy outcomes, including native heart recovery, heart replacement therapy, and mortality while on device support.
3. Define clinical scenarios linked to hemolysis, HRAEs, and arrhythmias and develop predictive models to mitigate their occurrence.

Conditions

  • Cardiogenic Shock
  • Mechanical Circulatory Support
  • Cardiogenic Shock Post Myocardial Infarction

Interventions

DEVICE

Micro-axial flow pump support

Temporary circulatory support using the Impella 5.5 micro-axial flow pump. The device is surgically placed (typically via the axillary artery) across the aortic valve into the left ventricle to provide active forward flow, unloading the left ventricle and maintaining systemic perfusion during cardiogenic shock. Management of the device includes the collection and analysis of continuous device-derived hemodynamic data and associated clinical parameters throughout the duration of support.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Thomas Schlöglhofer, PhD, MSc · Medical University of Vienna

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-08
Primary Completion
2029-01-08
Completion
2029-05-30
FDA Device
Yes

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

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 NCT07619144 on ClinicalTrials.gov