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The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support (E-Motion)

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ClinicalTrials.gov Identifier: NCT04634708
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Berlin Heart GmbH

Brief Summary:
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.

Condition or disease Intervention/treatment
Heart Failure Cardiomyopathies Ventricular Dysfunction Heart Diseases Cardiovascular Diseases Other: No intervention

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Group/Cohort Intervention/treatment
Pediatric patients on EXCOR VAD support Other: No intervention
No intervention due to observational design




Primary Outcome Measures :
  1. EXCOR Active device performance [ Time Frame: 52 days ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Twenty patients supported with the EXCOR® VAD. Patients must meet the eligibility criteria as specified and must not meet the exclusion criteria.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04634708


Contacts
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Contact: Thomas Schöndorf, Dr. Dr. PD +49-30 81872767 thomas.schoendorf.@berlinheart.de
Contact: Nadia Sinner +49-30 81872687 nadia.sinner@berlinheart.de

Locations
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Germany
Deutsches Herzzentrum Berlin Recruiting
Berlin, Germany
Sponsors and Collaborators
Berlin Heart GmbH
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Responsible Party: Berlin Heart GmbH
ClinicalTrials.gov Identifier: NCT04634708    
Other Study ID Numbers: E-20-330
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Berlin Heart GmbH:
EXCOR Ventricular Assist Device
EXCOR Active
Mobilization
Pediatric
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Cardiomyopathies
Ventricular Dysfunction