OPTIMIZE 5.5 - Optimizing Impella 5.5 Outcomes Through Advanced Data Science (NCT07619144) | Clinical Trial Compass
RecruitingNot Applicable
OPTIMIZE 5.5 - Optimizing Impella 5.5 Outcomes Through Advanced Data Science
Austria100 participantsStarted 2026-05-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems to be focused on testing a computer-based decision support tool for doctors using the Impella 5.5 device — rather than testing a new treatment directly on me — so can you help me understand what my actual role in the study would be and how my care might be affected?
2Since this trial is listed as 'Phase NA,' which often means it's more of a data science or device optimization study than a traditional drug or therapy trial, does that change the risk profile compared to a standard clinical trial I might be considering?
3The study involves cardiogenic shock, which is a life-threatening emergency condition — if I were to enroll, would decisions about my Impella 5.5 support still be made by you as my doctor, or could the algorithm's recommendations override your clinical judgment?
4Would participating in this trial affect the standard treatment I'd otherwise receive for cardiogenic shock, or would I receive exactly the same care I'd get outside the trial while also contributing data to the decision support tool?
5Given that the primary goal is measuring how well this predictive tool performs rather than directly improving my outcomes, is there any direct benefit to me as a participant, or would the main benefit be for future patients treated with the Impella 5.5?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Predictive Performance and Optimization of the Clinician Decision Support Tool
Timeframe: From the time of Impella 5.5 insertion up to device explant (estimated average of 5 to 14 days).