Evaluating infection management in children with heart-assist devices
Official title: Relapse of VAD Infections After Discontinuation of Anti-infective Therapies in Children.
Run by Claude Bernard University · NCT06464016 · Data updated 2026-11-12
This study looks at how to better manage infections in children using heart-assist devices to help improve their health while they wait for a heart transplant.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 18 Years |
| Sex | All |
| Enrollment | 47 (estimated) |
| Sponsor | Claude Bernard University Academic / other |
| Locations | 1 site (Lyon) |
| Status | Recruiting |
| Started | July 4, 2023 |
| Main results expected | October 1, 2025 |
| Study ends | November 1, 2025 |
| Registry record updated | January 28, 2025 |
| Trial ID | NCT06464016 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pediatric patients under 18 years old who are currently receiving support from the Berlin Heart EXCOR device.
✕Probably not a fit
Patients over 18 years old or those without proper documentation will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on children under 18 years of age who are receiving mechanical circulatory support using the Berlin Heart EXCOR device. It aims to evaluate the management of infections, which are common complications in patients with heart-assist devices. The study will gather data on infection rates and treatment approaches to improve outcomes for pediatric patients awaiting heart transplantation. The findings could help refine current guidelines and recommendations for infection management in this vulnerable population.
Why it matters
Potential benefit: If successful, this study could lead to improved infection management strategies for children with heart-assist devices, potentially reducing morbidity and mortality.
How similar studies have gone: There is limited existing research on infection management in pediatric patients with mechanical support, making this approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hospices Civils de Lyon
Lyon, France Recruiting
Study contacts
- Study coordinator: Charlotte Leclercq, MD PhD
- Email: chaleclercq@gmail.com
- Phone: +33787022785
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Letermovir versus valganciclovir to prevent CMV after heart transplant
This trial will test whether letermovir or valganciclovir better prevents CMV viremia in adults at moderate-to-high CMV risk after a heart transplant.
-
Intestinal microsporidiosis in French heart transplant recipients
This project will collect past medical data to see how often and how severe intestinal microsporidiosis is in heart transplant patients in France.
-
Levothyroxine for heart transplant recipients
This study is testing if taking levothyroxine can help heart transplant recipients live longer compared to those who receive a placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.