| NCT ID | NCT06741189 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Congenital Heart Defect |
| Study Type | INTERVENTIONAL |
| Enrollment | 186 participants |
| Start Date | 2025-10-30 |
| Primary Completion | 2028-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 186 participants in total. It began in 2025-10-30 with a primary completion date of 2028-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
We hypothesize that a home monitoring program combined with routine postoperative care significantly reduces morbidity and mortality after neonatal and pediatric cardiac surgery. This project differs from the previously published experiences by (a) providing an innovative telemedicine solution via the use of validated measurement sensors, (b) an alert system based on individualized standards, established for each care pathway, and (c) a protocolized response from medical teams in the management of alerts generated by the home monitoring tool.
Eligibility Criteria
Inclusion Criteria: * Patients aged between 0 and 36 months inclusive * With a congenital heart defect * Underwent cardiac surgery at Nantes University Hospital * Affiliated to a social security scheme * Free, informed and written consent of the 2 holders of parental authority Non Inclusion Criteria: * Clinical or family situation contraindicating a return home * Physical inability to connect to the Exolis platform at home * Insufficient understanding on the part of those with parental authority * Extracardiac co-morbidities responsible for organ failure requiring repeated * Hospitalisation for non-cardiovascular reasons (e.g. severe renal failure, neurological neurological deficit, complex immune deficiency, etc). * Patient and/or parents under legal protection
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06741189 clinical trial?
This trial is open to participants of all sexes, aged 0 Minutes or older, up to 36 Months, studying Congenital Heart Defect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06741189 currently recruiting?
Yes, NCT06741189 is actively recruiting participants. Contact the research team at albanelouen.baruteau@chu-nantes.fr for enrollment information.
Where is the NCT06741189 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT06741189 clinical trial?
NCT06741189 is sponsored by Nantes University Hospital. The trial plans to enroll 186 participants.