Clinical trial Recruiting at 1 site Observational Ages 18 and up

Optimizing Impella 5.5 Outcomes With Advanced Data Science

Official title: Clinical Outcomes and Adverse Events Associated With Microaxial Flow Pump Support: An Explorative Retrospective Study

Run by Medical University of Vienna · NCT07619144 · Data updated 2026-11-12

This study tests whether real-world data from Impella 5.5 patients with cardiogenic shock can help predict heart recovery and prevent complications, using advanced data science.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorMedical University of Vienna
Academic / other
Locations1 site (Vienna)
StatusRecruiting
StartedMay 8, 2026
Main results expectedJanuary 8, 2029
Study endsMay 30, 2029
Registry record updatedJune 1, 2026
Trial IDNCT07619144 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with cardiogenic shock treated with Impella 5.5 and with high-resolution pump data and ICU records available for analysis.

Probably not a fit

Patients without complete pump or ICU data or those treated for indications other than cardiogenic shock may not benefit from the predictive framework.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational work links high-resolution Impella 5.5 pump data with ICU electronic health records to build a clinical decision support tool. It validates pump placement signals against arterial waveforms and analyzes how device metrics relate to native heart recovery, need for heart replacement therapy, and mortality while on support. The project also aims to identify patterns associated with hemolysis, hemorrhagic risk events, and arrhythmias to develop predictive approaches that could mitigate these issues. Data management includes time-series alignment, data preprocessing, and retrospective longitudinal analysis to support future decisions in cardiogenic shock care. The study is conducted at the Medical University of Vienna using real-world data from adult patients treated with Impella 5.5 for cardiogenic shock.

Why it matters

Potential benefit: If successful, clinicians may have a data-driven tool to guide timely therapeutic decisions and reduce adverse events in patients on Impella 5.5.

How similar studies have gone: Previous studies have shown that integrating device data with clinical records can improve risk stratification, though this exact approach with Impella 5.5 data is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Adult patients who were treated for cardiogenic shock and supported with an Impella 5.5 micro-axial flow pump
* Only patients with available high-resolution pump data (downloaded from the clinical console) and ICU digital health record datasets

Exclusion Criteria:

* Patients supported with an Impella 5.5 for indications other than cardiogenic shock (e.g., protected PCI or CABG)
* Patients younger than 18 years
* Patients with incomplete data, procedural records, or demographic information

Where it's running

  • Medical University of Vienna
    Vienna, Austria
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.