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| Name | Class |
|---|---|
| Hospices Civils de Lyon | OTHER |
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Heart failure is a major cause of mortality and morbidity in children. Heart transplantation can significantly improve the prognosis of patients with severe heart failure, but access is limited by a shortage of transplants.
Long-term mechanical circulatory support is a major advance in the management of heart failure and can provide haemodynamic support while awaiting myocardial recovery or heart transplantation. The Berlin Heart (BH) EXCOR is the only long-term support system available for children.
Despite technical and medical advances in circulatory support, infection is a common complication and a major cause of morbidity and mortality in patients on BH.
There are few studies on the management of infection with mechanical support. Current ISHLT (International Society for Heart and Lung Transplantation) recommendations are based on expert opinion and observational studies. Some experts recommend anti-infective therapy until transplantation for specific support infections or for support-associated infections with persistent bacteraemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric patients with Berlin Heart EXCOR | Patient under 18 years old of age at the time of BH assistance in HCL Lyon France |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventricular Assist Device with Berlin Heart EXCOR | Device | The Berlin Heart® EXCOR is a type of "artificial heart" pump that pulls blood from the ventricle and then sends that blood to the aorta or pulmonary trunc, thereby taking away extra work from the native heart. The device, which comes in several sizes, is not totally implanted inside the body. |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse of VAD-infection after discontinuation of anti-infective therapy | Clinical and microbiological diagnosis of recurrence of infection with the same pathogen within 3 months of cessation of anti-infective therapy for a VAD-specific or VAD-related infection. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Children with terminal heart failure receiving BH assistance as bridge to transplant or bridge to recovery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte Leclercq, MD PhD | Contact | +33787022785 | chaleclercq@gmail.com | |
| Marc Lilot, MCU | Contact | +33651806521 | marc.lilot@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Luc Panetta, MD | Hospices Civils de Lyon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Recruiting | Lyon | 69677 | France |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006353 | Heart-Assist Devices |
| ID | Term |
|---|---|
| D001243 | Assisted Circulation |
| D013514 | Surgical Procedures, Operative |
| D006354 | Heart, Artificial |
| D019736 | Prostheses and Implants |
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|
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |