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Recruiting

NCT Number: NCT06464016

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

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.

Recruiting

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Key information

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon

Lyon, 69677, France

Location status: Recruiting

Location contact

Charlotte Leclercq, MD

PRINCIPAL_INVESTIGATOR

Marc Lilot, MCU

CONTACT

[email protected]

+33651806521

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Relapse of VAD-infection after discontinuation of anti-infective therapy

    Time frame: 3 months

    Clinical and microbiological diagnosis of recurrence of infection with the same pathogen within 3 months of cessation of anti-infective therapy for a VAD-specific or VAD-related infection.

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Leclercq, MD PhD

CONTACT

[email protected]

+33787022785

Marc Lilot, MCU

CONTACT

[email protected]

+33651806521

Sponsors and collaborators

Lead sponsor

Claude Bernard University

Other

Collaborators

  • Hospices Civils de Lyon

Registry information

Official study title

Relapse of VAD Infections After Discontinuation of Anti-infective Therapies in Children.

Acronym: VADINFECT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2024
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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