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NCT06464016 Clinical Trial

Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.

Infections Clinical Trial

— VADINFECT  

Official title:
Relapse of VAD Infections After Discontinuation of Anti-infective Therapies in Children.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06464016
Other study ID # AGORA n°23-5221
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 4, 2023
Est. completion date November 1, 2025

Study information
Verified date June 2024
Source Claude Bernard University
Contact Charlotte Leclercq, MD PhD
Phone +33787022785
Email chaleclercq@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 47
Est. completion date November 1, 2025
Est. primary completion date October 1, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Day to 18 Years
Eligibility Inclusion Criteria: - patients under 18yo of age with Berlin Heart assisting device in Hospices Civils de Lyon, in France. Exclusion Criteria: - patients over 18 yo at the time of BH assistance - unavailable documentation

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Ventricular Assist Device with Berlin Heart EXCOR
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.

Locations
Country Name City State
France Hospices Civils de Lyon Lyon

Sponsors (2)
Lead Sponsor Collaborator
Claude Bernard University Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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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