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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Medical University of Vienna
RECRUITING
Vienna
Contact Information
Primary
Thomas Schlöglhofer, PhD, MSc
thomas.schloeglhofer@meduniwien.ac.at
+4314040027280
Backup
Lukas Ruoff, MSc
lukas.ruoff@meduniwien.ac.at
Time Frame
Start Date: 2026-05-08
Estimated Completion Date: 2029-05-30
Participants
Target number of participants: 100
Treatments
Native heart recovery
Patients supported with the Impella 5.5 device (J\&J MedTech) achieving native heart recovery
Heart replacement therapy (durable MCS or HTX)
Patients supported with the Impella 5.5 device (J\&J MedTech) transitioning to heart replacement therapy (durable mechanical circulatory support or heart transplantation
All-cause mortality
Patients supported with the Impella 5.5 device (J\&J MedTech) suffering from all-cause mortality during mechanical circulatory support.
Sponsors
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov