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NCT Number: NCT06308055

Abiomed Impella RT-DAQ - Observational Study

Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition

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Key information

Conditions

Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uniklinik RWTH Aachen, Aachen, North Rhine-Westphalia, Germany

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About this study

The objective of this study is to develop algorithms for determining the cardiac output through the synchronous acquisition of hemodynamic data from the pulmonary artery catheter or other pressure sensors and Impella using a network module, which can replace invasive hemodynamic monitoring in the future.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ongoing or planned intensive care management with Impella support
  • Presence or planned placement of a cardiac output measurement
  • Preferentially pulmonary catheter (including cardiac output (CO) preferred as continuous measurement)
  • Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods

Exclusion criteria

  • Age < 18 years
  • Pregnancy
  • Anticipated support duration <24 h

Treatment and study plan

Data Acquisition

Other

Develop algorithms for determining the cardiac output through the synchronous acquisition of hemodynamic data from the pulmonary artery catheter or other pressure sensors and Impella using a network module.

Primary outcomes

  1. Collection of hemodynamic parameters (Cardiac Output in l/min)

    Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days

    Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.

  2. Collection of hemodynamic parameters (Blood Pressure in mmHg, Pulmonary Artery Pressure in mmHg, Central Venous Pressure in mmHg, Pulmonary Capillary Wedge Pressure in mmHg)

    Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days

    Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.

  3. Collection of hemodynamic parameters (Mixed Venous Saturation in %)

    Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days

    Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.

  4. Collection of hemodynamic parameters (Pulmonary Vascular Resistance in In dynes/sec/cm-5 )

    Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days

    Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.

Secondary outcomes

  1. Rate of Patient Survival

    Time frame: Once the Impella support is permanently weaned, on average 2 days

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Abiomed Inc.

Industry

Registry information

Official study title

Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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