Actively Recruiting

Age: 1Day - 18Years
All Genders
ID06464016

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

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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

Age: 1Day - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients under 18 years old using the Berlin Heart assisting device at Hospices Civils de Lyon, France
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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

Surveillance

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

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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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