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OpenTrials
Completed

NCT Number: NCT04634708

The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support

The purpose of this observational study is to evaluate the performance of the Berlin Heart EXCOR Active driving unit while being used with the approved EXCOR ventricular assist device system.

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Key information

Conditions

Heart Failure Cardiomyopathies Cardiovascular Diseases Heart Diseases Ventricular Dysfunction

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Deutsches Herzzentrum Berlin

Berlin, Germany

About this study

The study has a prospective, multicenter, international, single arm, observational design.

Study enrollment is expected to take 18 months and subjects will be followed until they reach an outcome or for 45 days on the EXCOR Active driving unit. The overall study duration is expected to be approximately 20 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pediatric patients meeting all indications as specified in the current version of the instructions for use (IFU) of the EXCOR® Active system,
  • Age < 18 years,
  • Patient and legal guardian has consented via signature on the study informed consent form,
  • Patient is able to get mobilized according to hospital standard and is currently supported with the Ikus driving unit. The decision if a patient is able to get mobilized is at the discretion of the investigator.

Exclusion criteria

  • Patient has any contraindication as specified in the current version of the IFU of the EXCOR® Active system,
  • Patient and/or legal representative has not given written consent to participate in the study (non-consent),
  • Females of childbearing age who are not on contraceptives or surgically sterile or who are pregnant.

Treatment and study plan

No intervention

Other

No intervention due to observational design

Primary outcomes

  1. EXCOR Active device performance

    Time frame: 52 days

Secondary outcomes

  1. Successful patient outcome rates

    Time frame: Whenever it happens or 52 days

    Successful outcome is defined as:

    • survival to transplant, or
    • survival to recovery/successful weaning, or
    • survival on EXCOR Pediatric at 45 days post-switch to EXCOR Active.

Other outcomes

  1. Safety of the device

    Time frame: 52 days

    • Adverse Events and Adverse Device Effects
    • Serious Adverse Events and Serious Adverse Device Effects

  2. Mobility

    Time frame: 52 days

    The mobility will be assessed with a patient diary.

  3. Quality of Life of the Patient and Family

    Time frame: 52 days

    The QoL will be assessed with questionnaires.

Sponsors and collaborators

Lead sponsor

Berlin Heart GmbH

Industry

Registry information

Acronym: E-Motion

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2020
Registry last updated
May 6, 2023

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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