Cardiomyopathies, Cardiovascular Diseases, Heart Diseases, Heart Failure, Ventricular Dysfunction
Conditions
Keywords
EXCOR Ventricular Assist Device, EXCOR Active, Mobilization, Pediatric
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.
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.
Interventions
OTHERNo intervention
No intervention due to observational design
Sponsors
Berlin Heart GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EXCOR Active device performance | 52 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed