Abiomed Impella RT-DAQ - Observational Study

March 12, 2024 updated by: Abiomed Inc.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients requiring cardiac Impella pump-support and intensive care therapy including cardiac output monitoring, eg. by pulmonary artery catheter at some point of therapy.

Initially, a collection of 250 patient days is aimed for. It is expected that each patient will be monitored by PAC for at least 48 hours, thus approximately 125 patients will be needed to achieve study objectives.

Description

Inclusion Criteria:

  1. Ongoing or planned intensive care management with Impella support

  2. Presence or planned placement of a cardiac output measurement

    1. Preferentially pulmonary catheter (including cardiac output (CO) preferred as continuous measurement)
    2. Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods

Exclusion Criteria:

  1. Age < 18 years
  2. Pregnancy
  3. Anticipated support duration <24 h

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Impella insertion unitl Impella support is permanently weaned, on average 2 days
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.
From Impella insertion unitl Impella support is permanently weaned, on average 2 days
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.
From Impella insertion unitl Impella support is permanently weaned, on average 2 days
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.
From Impella insertion unitl Impella support is permanently weaned, on average 2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of Patient Survival
Time Frame: Once the Impella support is permanently weaned, on average 2 days
Once the Impella support is permanently weaned, on average 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abiomed Inc.

Investigators

  • Principal Investigator: Alexander Kersten, MD, Uniklinik RWTH Aachen, Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-R01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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