Hospices Civils de Lyon
Lyon, 69677, France
Location status: Recruiting
Location contact
Charlotte Leclercq, MD
PRINCIPAL_INVESTIGATOR
Marc Lilot, MCU
CONTACT
NCT Number: NCT06464016
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.
Interested in participating?
Request Info1 day–18 year
All sexes
Observational
Lyon, 69677, France
Location status: Recruiting
Charlotte Leclercq, MD
PRINCIPAL_INVESTIGATOR
Marc Lilot, MCU
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months
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.
Contact information is provided by the study sponsor or research team.
Charlotte Leclercq, MD PhD
CONTACT
Marc Lilot, MCU
CONTACT
Claude Bernard University
Other
Relapse of VAD Infections After Discontinuation of Anti-infective Therapies in Children.
Acronym: VADINFECT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03580759
Exercise Training, Heart Failure NYHA Class IV
Omaha, Nebraska, United States
View Trial DetailsNCT03093012
Cardiovascular Diseases, Heart Diseases
Houston, Texas, United States
View Trial DetailsNCT02344576
Cardiovascular Diseases, Heart Diseases
Aurora, Colorado, United States
View Trial DetailsNCT03105726
Cardiovascular Diseases, Heart Diseases
View Trial Details