Abiomed Impella RT-DAQ - Observational Study

NCT ID: NCT06308055

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-04

Study Completion Date

2026-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cardiogenic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Data Acquisition

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abiomed Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Kersten, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Uniklinik RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status

UKSH Campus Kiel

Kiel, Schleswig-Holstein, Germany

Site Status

Asklepios Klinik Altona

Hamburg, , Germany

Site Status

IRCCS Ospedale San Raffaele

Milan, MI, Italy

Site Status

Universitätsspital Basel

Basel, , Switzerland

Site Status

Countries

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Germany Italy Switzerland

Other Identifiers

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2022-R01

Identifier Type: -

Identifier Source: org_study_id

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