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

Sponsor

Berlin Heart GmbH (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04634708

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Nov 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Pediatric patients on EXCOR VAD support

Other: No intervention

No intervention due to observational design

Outcome Measures

Primary Outcome Measures

EXCOR Active device performance [52 days]

Secondary Outcome Measures

Successful patient outcome rates [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

Safety of the device [52 days]
Adverse Events and Adverse Device Effects Serious Adverse Events and Serious Adverse Device Effects
Mobility [52 days]
The mobility will be assessed with a patient diary.
Quality of Life of the Patient and Family [52 days]
The QoL will be assessed with questionnaires.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.