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ID06308055

Observational Study to Develop Cardiac Output Monitoring Algorithms Using Impella Support in Patients with Cardiogenic Shock

Led by Abiomed Inc. · Updated on 2026-06-17

125

Participants Needed

4

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

This observational study focuses on patients experiencing cardiogenic shock who require intensive care management with Impella support. The main goal is to develop algorithms that can determine cardiac output by synchronously acquiring hemodynamic data from devices like the pulmonary artery catheter or other pressure sensors alongside the Impella system. This approach aims to potentially replace invasive hemodynamic monitoring in the future. Participants in this study will be monitored while receiving Impella support, with data collected from continuous or discontinuous cardiac output measurements such as pulmonary catheters or echocardiography. The study collects hemodynamic parameters including cardiac output, blood pressure, pulmonary artery pressure, central venous pressure, pulmonary capillary wedge pressure, mixed venous saturation, and pulmonary vascular resistance during the period from Impella insertion until support is permanently weaned, which typically lasts around two days. During their participation, patients will have their hemodynamic data continuously recorded and analyzed to aid algorithm development. Researchers will also track patient survival after Impella support ends. The study involves no intervention beyond standard care, focusing on data acquisition and monitoring. Total participation duration aligns with the time the Impella device is in use, averaging about two days.

CONDITIONS

Brief Title

Abiomed Impella RT-DAQ - Observational Study

Research Team

A

Andreas Goetzenich, MD, PhD, MBA, FAHA, FESC

K

Kirstin Starke

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