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

NCT06464016 | Recruiting

• 1 other identifier: AGORA n°23-5221
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart-Assist Devices; Infections; Heart Transplant Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

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.

Pediatric patients with Berlin Heart EXCOR

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• patients under 18yo of age with Berlin Heart assisting device in Hospices Civils de Lyon, in France.

You may not qualify if:

• patients over 18 yo at the time of BH assistance
• unavailable documentation

Sponsors & Collaborators

• Claude Bernard University: lead
• Hospices Civils de Lyon: collaborator

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69677, France

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Heart-Assist Devices

Intervention Hierarchy (Ancestors)

Assisted Circulation; Surgical Procedures, Operative; Heart, Artificial; Prostheses and Implants; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• Luc Panetta, MD

  Hospices Civils de Lyon

  STUDY DIRECTOR

Central Study Contacts

Charlotte Leclercq, MD PhD

CONTACT

+33787022785; chaleclercq@gmail.com

Marc Lilot, MCU

CONTACT

+33651806521; marc.lilot@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Official Director

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: June 18, 2024
• Study Start: July 4, 2023
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

FR (1)