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

May 3, 2023 updated by: Berlin Heart GmbH
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Deutsches Herzzentrum Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
EXCOR Active device performance
Time Frame: 52 days
52 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Whenever it happens or 52 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the device
Time Frame: 52 days
  • Adverse Events and Adverse Device Effects
  • Serious Adverse Events and Serious Adverse Device Effects
52 days
Mobility
Time Frame: 52 days
The mobility will be assessed with a patient diary.
52 days
Quality of Life of the Patient and Family
Time Frame: 52 days
The QoL will be assessed with questionnaires.
52 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Berlin Heart GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

September 15, 2022

Study Completion (Actual)

September 15, 2022

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (Actual)

November 18, 2020

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-20-330

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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