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

Recruiting

• Conditions: Heart-Assist Devices; Infections; Heart Transplant Infection
• Interventions: Device: Ventricular Assist Device with Berlin Heart EXCOR

• Registration Number: NCT06464016
• Lead Sponsor: Claude Bernard University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-04
• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2024-06-15
• Study First Posted: 2024-06-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-10-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric patients with Berlin Heart EXCOR	Ventricular Assist Device with Berlin Heart EXCOR	Patient under 18 years old of age at the time of BH assistance in HCL Lyon France

Primary Outcome Measures

Name	Time	Method
Relapse of VAD-infection after discontinuation of anti-infective therapy	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.

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France