Heart-Assist DevicesVADINFECTNCT06464016
Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.
An observational study of Heart-Assist Devices and Infections, run by Claude Bernard University at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Heart-Assist Devices, Infections, Heart Transplant Infection
- What is being tested?
- Ventricular Assist Device with Berlin Heart EXCOR
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jul 2023to 1 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with terminal heart failure receiving BH assistance as bridge to transplant or bridge to recovery.
Who may be able to join
- patients under 18yo of age with Berlin Heart assisting device in Hospices Civils de Lyon, in France.
Who cannot join
- patients over 18 yo at the time of BH assistance
- unavailable documentation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon, 69677
Marc Lilot, MCU, +33651806521, marc.lilot@chu-lyon.fr
Charlotte Leclercq, MD
About this study
Official title: 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.
Read more
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
- Being tested
- Ventricular Assist Device with Berlin Heart EXCOR
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventricular Assist Device with Berlin Heart EXCORDevice
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 group | Role | What they receive |
|---|---|---|
| Pediatric patients with Berlin Heart EXCOR | Patient under 18 years old of age at the time of BH assistance in HCL Lyon France Receives: Device: Ventricular Assist Device with Berlin Heart EXCOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start4 Jul 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart-Assist DevicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Principal investigator, Lilot Marc, Claude Bernard University
- Investigators
- Luc Panetta, MD, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464016
- Sponsor's protocol ID
- AGORA n°23-5221
- Acronym
- VADINFECT
- Status last verified
- Jan 2025
- First submitted
- 10 Oct 2023
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relapse of VAD Infections After Discontinuation of Anti-infective Therapies in Children.
- ClinicalTrials.gov ID
- NCT06464016
- Acronym / sponsor ID
- VADINFECT / AGORA n°23-5221
- Conditions
- Heart-Assist Devices, Infections, Heart Transplant Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with Berlin Heart EXCOR | – | Device: Ventricular Assist Device with Berlin Heart EXCORPatient under 18 years old of age at the time of BH assistance in HCL Lyon France |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with terminal heart failure receiving BH assistance as bridge to transplant or bridge to recovery.
Key inclusion criteria (1 listed)
- patients under 18yo of age with Berlin Heart assisting device in Hospices Civils de Lyon, in France.
Key exclusion criteria (2 listed)
- patients over 18 yo at the time of BH assistance
- unavailable documentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventricular Assist Device with Berlin Heart EXCORThe 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. | Device | Pediatric patients with Berlin Heart EXCOR |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luc Panetta, MD study director
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart-Assist Devices and Infections, run by Claude Bernard University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Leclercq, MD PhD (+33787022785, chaleclercq@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse of VAD-infection after discontinuation of anti-infective therapy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.