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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Status | Recruiting |
| Started | May 8, 2026 |
| Main results expected | January 8, 2029 |
| Study ends | May 30, 2029 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT07619144 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
- Principal investigator: Thomas Schlöglhofer, PhD, MSc — Medical University of Vienna
- Study coordinator: Thomas Schlöglhofer, PhD, MSc
- Email: thomas.schloeglhofer@meduniwien.ac.at
- Phone: +4314040027280
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Cardiogenic Shock Outcomes Registry (COR-SHOCK): how patients fare over time
This observational registry tests how outcomes and management of cardiogenic shock have changed over the years in adults receiving routine care.
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Outcomes in patients with mixed cardiogenic and vasoplegic shock
This registry will try to describe outcomes and risk factors in adults admitted with cardiogenic shock who also have inappropriate vasodilation (mixed cardiogenic‑vasoplegic shock).
-
Factors Influencing Outcomes in ECMO and Impella Patients
This study tests whether metabolic and thyroid hormone changes help predict survival for adults on ECMO or Impella at a single Hungarian cardiac ICU.
-
Evaluating a noninvasive tissue sensor to detect cardiogenic shock earlier in heart patients
This pilot, noninvasive study tests whether the NIRSense wearable can help detect deterioration in adults with cardiogenic shock risk due to heart attack or heart failure.
-
Safety and Efficacy of an Extracorporeal Ventricular Assist System for Cardiogenic Shock
This study tests whether an extracorporeal ventricular assist device can safely provide short-term heart support and help patients with cardiogenic shock or trouble weaning from bypass.
-
Left Ventricular Support and Advanced Monitoring in AMI–Cardiogenic Shock: Immediate Impella Use and PAC/Monitoring vs Standard Care
In adults with heart attack-related cardiogenic shock, this trial tests whether using an Impella left ventricular assist device and/or protocolized pulmonary artery catheter monitoring improves survival compared with standard care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.