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

Berlin Heart

Status: Completed

Conditions: Ventricular Dysfunction; Cardiovascular Diseases; Heart Failure; Heart Diseases; Cardiomyopathies

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04634708

E-20-330

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: Under 17 years old

Volunteers: No 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.

Trial design

24 participants in 1 patient group

Pediatric patients on EXCOR VAD support

Treatment:

Other: No intervention