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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric patients on EXCOR VAD support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention due to observational design |
|
| Measure | Description | Time Frame |
|---|---|---|
| EXCOR Active device performance | 52 days |
| Measure | Description | Time Frame |
|---|---|---|
| Successful patient outcome rates | Successful outcome is defined as:
| Whenever it happens or 52 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the device |
| 52 days |
| Mobility | The mobility will be assessed with a patient diary. |
Inclusion Criteria:
Exclusion Criteria:
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Twenty patients supported with the EXCOR® VAD. Patients must meet the eligibility criteria as specified and must not meet the exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum Berlin | Berlin | Germany |
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| 52 days |
| Quality of Life of the Patient and Family | The QoL will be assessed with questionnaires. | 52 days |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009202 | Cardiomyopathies |
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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