Abiomed Impella RT-DAQ - Observational Study

NCT06308055 | Active Not Recruiting

• 1 other identifier: 2022-R01
• Study Type: observational
• Target: 125
• Locations: 3 countries
• Sites: 5

Brief Summary

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

Conditions

Cardiogenic Shock

Outcome Measures

Primary Outcomes (4)

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

  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)

  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 %)

  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 )

  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 Outcomes (1)

• Rate of Patient Survival

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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Abiomed Inc.: lead

Study Sites (5)

Uniklinik RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

UKSH Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Asklepios Klinik Altona

Hamburg, 22763, Germany

Location

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

Universitätsspital Basel

Basel, Switzerland

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexander Kersten, MD

  Uniklinik RWTH Aachen, Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: March 13, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

DE (3); IT (1); CH (1)