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
|Condition or disease||Intervention/treatment|
|Heart Failure Cardiomyopathies Ventricular Dysfunction Heart Diseases Cardiovascular Diseases||Other: No intervention|
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|
|Estimated Enrollment :||20 participants|
|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|
|Pediatric patients on EXCOR VAD support||
Other: No intervention
No intervention due to observational design
- EXCOR Active device performance [ Time Frame: 52 days ]
- 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.
- Safety of the device [ Time Frame: 52 days ]
- Adverse Events and Adverse Device Effects
- Serious Adverse Events and Serious Adverse Device Effects
- Mobility [ Time Frame: 52 days ]The mobility will be assessed with a patient diary.
- Quality of Life of the Patient and Family [ Time Frame: 52 days ]The QoL will be assessed with questionnaires.
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
|Contact: Thomas Schöndorf, Dr. Dr. PD||+49-30 81872767||thomas.schoendorf.@berlinheart.de|
|Contact: Nadia Sinner||+49-30 firstname.lastname@example.org|
|Deutsches Herzzentrum Berlin||Recruiting|