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

Sponsor
Claude Bernard University
Study ID
NCT06464016
Status
Recruiting
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Conditions

  • Heart Transplant Infection
  • Heart-Assist Devices
  • Infections

Eligibility Criteria

Sex
ALL
Age
1 Day - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Ventricular Assist Device with Berlin Heart EXCOR — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jun 18, 2024
Start date
Jul 4, 2023
Status verified
Jan 2025
Primary completion
Oct 1, 2025
Completion
Nov 1, 2025

Study Design

Enrollment
47 participants (estimated)

Arms

  • Arm: Pediatric patients with Berlin Heart EXCOR
    Patient under 18 years old of age at the time of BH assistance in HCL Lyon France

Primary Outcome Measure

Relapse of VAD-infection after discontinuation of anti-infective therapy [ Time Frame: 3 months ]

Central Contacts

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