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The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks and to assess clinical improvement on both short- and long-term.
The registry study has an observational, prospective, international, multi-center, non-randomized design.
The registry is planned for 42 months (3.5 years), with an enrollment period of 28 months, the follow-up of up to 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with failing/absence of the right heart | Patients with acute or chronic, conservatively uncontrollable heart failure of varying pathogenesis, graded as stage III or IV according to NYHA, with an anticipated need for short-term to long-term right ventricular or biventricular support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention due to observational design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of mortality | Short-term mortality | 30 days |
| Rate of major bleeding | Short-term rate of major bleeding | 30 days |
| Rate of thrombosis | Short-term rate of thrombosis | 30 days |
| Survival to heart transplantation | Long-term survival to heart transplantation | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse events | Safety of the device | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Twenty patients with failing/absence of the right heart. The indications on RVAD and BVAD use of the EXCOR VAD apply.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Schöndorf, Dr. Dr. PD | Contact | +49 30 81872600 | clinical.science@berlinheart.de | |
| Eleonora Dal Sasso, Dr. | Contact | +49 30 81872600 | clinical.science@berlinheart.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMU Klinikum | Recruiting | Munich | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36368697 | Derived | Dal Sasso E, Schondorf T, Schluter KJ, Miera O, De Rita F, Menon AK; European EXCOR(R) Pediatric Investigator Group (EEPIG). A Novel Strategy for the Mechanical Subpulmonary Support in Failing Fontan Patients. Thorac Cardiovasc Surg. 2022 Dec;70(S 03):e34-e41. doi: 10.1055/s-0042-1757916. Epub 2022 Nov 11. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D000080039 | Univentricular Heart |
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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