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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infections; Heart Transplant Infection; Heart-Assist Devices
• Intervention / Treatment: Device: Ventricular Assist Device with Berlin Heart EXCOR

• Study Type: Observational
• Enrollment (Estimated): 47

Contacts and Locations

• Study Contact: Name: Charlotte Leclercq, MD PhD; Phone Number: +33787022785; Email: chaleclercq@gmail.com
• Study Contact Backup: Name: Marc Lilot, MCU; Phone Number: +33651806521; Email: marc.lilot@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69677
    • Recruiting
    • Hospices Civils de Lyon
    • Contact: Marc Lilot, MCU; Phone Number: +33651806521; Email: marc.lilot@chu-lyon.fr
    • Contact: Charlotte Leclercq, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children with terminal heart failure receiving BH assistance as bridge to transplant or bridge to recovery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric patients with Berlin Heart EXCOR; Patient under 18 years old of age at the time of BH assistance in HCL Lyon France	Device: Ventricular Assist Device with Berlin Heart EXCOR; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse of VAD-infection after discontinuation of anti-infective therapy	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.	3 months

Collaborators and Investigators

• Sponsor: Claude Bernard University
• Collaborators: Hospices Civils de Lyon
• Investigators: Study Director: Luc Panetta, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: June 15, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: AGORA n°23-5221

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No