Actively Recruiting
Relapse of VAD Infections After Stopping Anti-infective Therapies in Children Using Berlin Heart EXCOR
Led by Claude Bernard University · Updated on 2025-01-28
47
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
C
Claude Bernard University
Lead Sponsor
H
Hospices Civils de Lyon
Collaborating Sponsor
AI-Summary
What this Trial Is About
Heart failure is a serious health issue in children that can lead to death or serious illness. Heart transplantation can improve outcomes for severe cases, but the number of available transplants is limited. Mechanical circulatory support, such as the Berlin Heart EXCOR device, provides important long-term support for children awaiting heart recovery or transplantation. However, infections remain a common and serious complication during this support. The Berlin Heart EXCOR is a specialized device that acts like an artificial heart pump, helping the heart by moving blood from the ventricle to major arteries. This device is not fully implanted inside the body and comes in various sizes suitable for children. This observational study focuses on children under 18 years old who are using the Berlin Heart EXCOR at a specific hospital in France. Researchers are examining infections related to this device, especially looking at what happens when anti-infective therapies are stopped. Participants will be monitored for infection relapse within three months after stopping anti-infective treatments. The study observes how infections return and collects medical data related to infection management in children using the device. This helps researchers understand the risks and outcomes associated with stopping infection treatments during mechanical circulatory support. The study period is organized to track infections and patient health outcomes over time.
CONDITIONS
Brief Title
Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients under 18 years old using the Berlin Heart assisting device at Hospices Civils de Lyon, France
You will not qualify if you...
- Patients over 18 years old at the time of Berlin Heart assistance
- Unavailable or incomplete medical documentation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of device assistance as per routine care
Participants are observed while using the Berlin Heart EXCOR ventricular assist device.
Regular visits as part of routine healthcare
Duration - 3 months
Participants are monitored for relapse of ventricular assist device infections after stopping anti-infective therapies.
Visits scheduled according to infection monitoring protocol
Trial Site Locations
Total: 1 location
1
Hospices Civils de Lyon
Lyon, France, 69677
Actively Recruiting
Research Team
C
Charlotte Leclercq, MD PhD
M
Marc Lilot, MCU
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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