Heart FailureE-MotionNCT04634708
The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support
An observational study of Heart Failure and Cardiomyopathies, run by Berlin Heart GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Heart Failure, Cardiomyopathies, Ventricular Dysfunction
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2020to 15 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Twenty patients supported with the EXCOR® VAD. Patients must meet the eligibility criteria as specified and must not meet the exclusion criteria.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Heart Failure, Cardiomyopathies, Ventricular Dysfunction, Heart Diseases, Cardiovascular Diseases
- Being tested
- No intervention
- Keywords
- EXCOR Ventricular Assist Device, EXCOR Active, Mobilization, Pediatric
- Medical subject headings
- Heart Failure, Cardiomyopathies, Ventricular Dysfunction, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention due to observational design
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients on EXCOR VAD support | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
EXCOR Active device performance
Measured: 52 days
Secondary outcomes (1)
Successful patient outcome rates
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.
Measured: Whenever it happens or 52 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Nov 2020
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berlin Heart GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634708
- Sponsor's protocol ID
- E-20-330
- Acronym
- E-Motion
- Status last verified
- May 2023
- First submitted
- 12 Nov 2020
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support
- ClinicalTrials.gov ID
- NCT04634708
- Acronym / sponsor ID
- E-Motion / E-20-330
- Conditions
- Heart Failure, Cardiomyopathies, Ventricular Dysfunction, Heart Diseases, Cardiovascular Diseases
- Keywords
- EXCOR Ventricular Assist Device, EXCOR Active, Mobilization, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Berlin Heart GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients on EXCOR VAD support | – | Other: No intervention |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Twenty patients supported with the EXCOR® VAD. Patients must meet the eligibility criteria as specified and must not meet the exclusion criteria.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention due to observational design | Other | Pediatric patients on EXCOR VAD support |
Primary outcome
EXCOR Active device performance
Time frame: 52 days
1 secondary outcome
Successful patient outcome rates
Time frame: Whenever it happens or 52 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiomyopathies, run by Berlin Heart GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EXCOR Active device performance (time frame: 52 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.