No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
0 Minutes – 36 Months
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
186 (estimated)
Sponsor
Nantes University Hospital · Other
Who this trial is looking for
This trial is looking for children aged 0 to 36 months who have a congenital heart defect and have had heart surgery at Nantes University Hospital. Participants will be involved in a home monitoring program to help reduce health risks after their surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 0 and 36 months old
I have a congenital heart defect
I have had cardiac surgery at Nantes University Hospital
I am covered by a social security scheme
I have consent from my parents or guardians
You may not be able to join if
I have a clinical situation that doesn't allow me to go home
I cannot connect to the Exolis platform at home
I don’t fully understand the information given to my parents or guardians
I have extracardiac conditions that lead to organ failure or hospitalizations
I am under legal protection
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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, esta…
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.
Trial Locations
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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 Criter…
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
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