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Abiomed Impella RT-DAQ - Observational Study

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Abiomed

Status

Active, not recruiting

Conditions

Cardiogenic Shock

Treatments

Other: Data Acquisition

Study type

Observational

Funder types

Industry

Identifiers

NCT06308055
2022-R01

Details and patient eligibility

About

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

Full 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.

Enrollment

125 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

5

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Central trial contact

Andreas Goetzenich, MD, PhD, MBA, FAHA, FESC; Kirstin Starke

Data sourced from clinicaltrials.gov

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