NCT06464016 Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.
| NCT ID | NCT06464016 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Claude Bernard University |
| Condition | Heart-Assist Devices |
| Study Type | OBSERVATIONAL |
| Enrollment | 47 participants |
| Start Date | 2023-07-04 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 47 participants in total. It began in 2023-07-04 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Luc Panetta, MD
STUDY DIRECTOR
Hospices Civils de Lyon
Frequently Asked Questions
Who can join the NCT06464016 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 18 Years, studying Heart-Assist Devices. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06464016 currently recruiting?
Yes, NCT06464016 is actively recruiting participants. Contact the research team at chaleclercq@gmail.com for enrollment information.
Where is the NCT06464016 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT06464016 clinical trial?
NCT06464016 is sponsored by Claude Bernard University. The principal investigator is Luc Panetta, MD at Hospices Civils de Lyon. The trial plans to enroll 47 participants.