Congenital Heart DefectOSCARNCT06741189
Cardiopediatric Home Monitoring Tool
A study testing Home monitoring and usual medical monitoring in people with Congenital Heart Defect, run by Nantes University Hospital at 1 site in France.
Trial summary
We hypothesize that a home monitoring program combined with routine postoperative care significantly reduces morbidity and mortality after neonatal and pediatric cardiac surgery. Read more about this study
- Who is it for?
- Ages 0 minutes to 36 months
- Conditions the study is for
- Congenital Heart Defect
- What is being tested?
- Home monitoring and usual medical monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2025to 30 Jul 2028
- Phase
- Interventional
- 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 0 minutes to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
None listed.
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
CHU de Nantes
Nantes
Alban BARUTEAU, 0240087742, albanelouen.baruteau@chu-nantes.fr
About this study
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.
Read the detailed description
Affecting 12-million people worldwide and 7,400 newborns/year in France, congenital heart defects (CHD) are the leading cause of birth defects and a major cause of morbidity and mortality in childhood.
It is (a) a growing patient population, due to an increase in birth prevalence and survival, and (b) a major public health issue, due to a substantial use of healthcare resources and a dramatic impact on quality of life. CHDs concerned by the OSCAR project are rare diseases (prevalence <1/2000 births) operated on at birth or in infancy. These CHDs expose affected newborns/infants to the risk of major cardiovascular events (fainting, cyanosis, arrhythmias) and/or rapid cardiac decompensation occurring at home in the postoperative period, justifying close ambulatory monitoring to detect early warning signs of complication or decompensation (such as oxygen desaturation, accelerated heart rate, poor weight gain, altered tone, etc.)
This risk is particularly high in certain critical postoperative situations, such as when the physiology of a single ventricle is palliated by a shunt (modified Blalock-Taussig systemic-pulmonary anatomy), or in the intermediate period (interstage) between two palliative surgeries in a Norwood program. In view of the high ambulatory mortality (12-20% in current series) during the interstage of a Norwood program, some expert centers around the world have opted not to discharge operated neonates home, preferring to keep in-hospital monitoring during 4 to 5 months, until stage 2, thus reducing mortality during this critical period. In Anglo-Saxon countries, an outpatient monitoring program has been developed as an alternative for these vulnerable patients, sometimes accompanied by a telemedicine solution, greatly reducing postoperative mortality. This type of outpatient follow-up program does not exist in France.
- Conditions
- Congenital Heart Defect
- Being tested
- Home monitoring, usual medical monitoring
- Keywords
- Congenital heart defects, cardiac surgery, care pathway, home monitoring, morbidity and mortality
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home monitoringOther
The key parameters (heart rate, arterial oxygen saturation, weight) will be measured at home using the measurement tools used by the parents, and tele-transmitted at a discontinuous rate, i.e. once a day for 4 weeks, then once a week for 20 weeks. The measurement tools will be given to the family before discharge from the hospital ward. These parameters will be entered into the Exolis platform, in addition to a very brief questionnaire designed to provide information about the child's diet, muscle tone and any medication he or she is taking. taken by the child.
An alert will be automatically generated for the pediatric cardiology team if the data transmitted by the measurement sensors deviates from an individualized standard, defined for each child and/or each care pathway at the multidisciplinary consultation meeting before the child returns home.
The response will be standardized on the basis of a protocol shared by the 4 investigating centers.
usual medical monitoringOther
During the first 4 weeks: a weekly consultation including a record of intercurrent events (malaise, cyanosis, hyperthermia, eating difficulties), a record of weight and vital constants (oxygen saturation, heart rate), an examination of the sternotomy or thoracotomy scar, a clinical cardiovascular examination, a 12-lead electrocardiogram and a transthoracic echocardiogram.
During the following 20 weeks: a consultation at 1, 3 and 6 months including the same assessment procedures.
| Study group | Role | What they receive |
|---|---|---|
| standard group | Active comparator | The usual medical monitoring for the first six months postoperatively is standardized between the 4 university hospital centres concerned and consists of :
1. during the first 4 weeks: a weekly consultation including a record of intercurrent events (malaise, cyanosis, hyperthermia, eating difficulties), a record of weight and vital constants (oxygen saturation, heart rate), an examination of the sternotomy or thoracotomy scar, a clinical cardiovascular examination, a 12-lead electrocardiogram and a transthoracic echocardiogram.
2. during the following 20 weeks: a consultation at 1, 3 and 6 months including the same assessment procedures. Receives: Other: usual medical monitoring |
| home monitoring group | Experimental | In addition to the usual post-operative monitoring, OSCAR home monitoring will enable key parameters to be transmitted to the medical team at a discontinuous rate (once a day for 4 weeks, then once a week for 20 weeks) via a brief questionnaire (smartphone application) and measurement sensors (weight, oxygen saturation, heart rate) linked to an interface, from the first day the patient returns home until the 6th month post-operatively. The values entered will be automatically compared with individualized standards established for each child at a multidisciplinary meeting, and any deviation from the standard will generate an alert. and the response of the medical teams will be protocolized. Receives: Other: Home monitoring; Other: usual medical monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing postoperative morbidity and mortality
The main objective is to evaluate the impact of home monitoring in reducing postoperative morbidity and mortality in patients aged 0 to 36 months who have undergone MCC.
Measured: 6th month post-op
Secondary outcomes (11)
Children's quality of life
Assess the impact of OSCAR surveillance by comparing the 2 groups:
Children's quality of life during the postoperative period.
Measured: 0,1 month, 3 months and 6 months post op
Parents' quality of life
Assess the impact of OSCAR surveillance by comparing the 2 groups:
Parents' quality of life during the postoperative period
Measured: 0,1 month, 3 months and 6 months post op
Parental stress
Assess the impact of OSCAR surveillance by comparing the 2 groups:
Parental stress and family impact during the postoperative period
Measured: 0,1 month, 3 months and 6 months post op
Children's weight growth
Assess the impact of OSCAR surveillance by comparing the 2 groups:
Children's weight growth during the postoperative period
Measured: 1 month, 3 months and 6 months post op
Post-traumatic stress syndromes
Assess the impact of OSCAR surveillance by comparing the 2 groups:
The prevalence of post-traumatic stress syndromes in parents at the postoperative month.
Measured: 6 months post op
Serious non-cardiovascular events
Assess the impact of OSCAR surveillance by comparing the 2 groups:
The rate of serious non-cardiovascular events (in order to study a potential delay in the management of these events in the group with OSCAR monitoring group due to increased follow-up).
Measured: 6 months post op
Factors other than management
To study the impact of factors other than management (OSCAR monitoring versus management) on the parents' quality of life, parental stress and family impact family impact, children's weight gain, and the presence of post-traumatic stress post-traumatic stress disorder in the parents 6 months after the operation.
Measured: 6 months post op
Therapeutic education program
Evaluate the conditions for implementing OSCAR surveillance by assessing :
The relevance of the OSCAR therapeutic education program (ETP) for the parents in the group concerned.
Measured: 6 months post op
Acceptability of monitoring for the parents
Evaluate the conditions for implementing OSCAR surveillance by assessing :
The acceptability of monitoring for the parents in the group concerned.
Measured: 6 months post op
Acceptability of the monitoring for the medical teams
Evaluate the conditions for implementing OSCAR surveillance by assessing :
The acceptability of the monitoring for the medical teams (investigating hospital investigating hospital medical teams and the child's routine care medical teams).
Measured: 6 months post op
Efficiency
Evaluate the conditions for implementing OSCAR surveillance by assessing : its efficiency.
Measured: 6 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start30 Oct 2025
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741189
- Sponsor's protocol ID
- RC24_0146
- Acronym
- OSCAR
- Status last verified
- Jun 2026
- First submitted
- 16 Dec 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopediatric Home Monitoring Tool
- ClinicalTrials.gov ID
- NCT06741189
- Acronym / sponsor ID
- OSCAR / RC24_0146
- Conditions
- Congenital Heart Defect
- Keywords
- Congenital heart defects, cardiac surgery, care pathway, home monitoring, morbidity and mortality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 18 Dec 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.
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.
Detailed description
Affecting 12-million people worldwide and 7,400 newborns/year in France, congenital heart defects (CHD) are the leading cause of birth defects and a major cause of morbidity and mortality in childhood.
It is (a) a growing patient population, due to an increase in birth prevalence and survival, and (b) a major public health issue, due to a substantial use of healthcare resources and a dramatic impact on quality of life. CHDs concerned by the OSCAR project are rare diseases (prevalence <1/2000 births) operated on at birth or in infancy. These CHDs expose affected newborns/infants to the risk of major cardiovascular events (fainting, cyanosis, arrhythmias) and/or rapid cardiac decompensation occurring at home in the postoperative period, justifying close ambulatory monitoring to detect early warning signs of complication or decompensation (such as oxygen desaturation, accelerated heart rate, poor weight gain, altered tone, etc.)
This risk is particularly high in certain critical postoperative situations, such as when the physiology of a single ventricle is palliated by a shunt (modified Blalock-Taussig systemic-pulmonary anatomy), or in the intermediate period (interstage) between two palliative surgeries in a Norwood program. In view of the high ambulatory mortality (12-20% in current series) during the interstage of a Norwood program, some expert centers around the world have opted not to discharge operated neonates home, preferring to keep in-hospital monitoring during 4 to 5 months, until stage 2, thus reducing mortality during this critical period. In Anglo-Saxon countries, an outpatient monitoring program has been developed as an alternative for these vulnerable patients, sometimes accompanied by a telemedicine solution, greatly reducing postoperative mortality. This type of outpatient follow-up program does not exist in France.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard group | Active comparator | Other: usual medical monitoringThe usual medical monitoring for the first six months postoperatively is standardized between the 4 university hospital centres concerned and consists of : 1. during the first 4 weeks: a weekly consultation including a record of intercurrent events (malaise, cyanosis, hyperthermia, eating difficulties), a record of weight and vital constants (oxygen saturation, heart rate), an examination of the sternotomy or thoracotomy scar, a clinical cardiovascular examination, a 12-lead electrocardiogram and a transthoracic echocardiogram. 2. during the following 20 weeks: a consultation at 1, 3 and 6 months including the same assessment procedures. |
| home monitoring group | Experimental | Other: Home monitoring, Other: usual medical monitoringIn addition to the usual post-operative monitoring, OSCAR home monitoring will enable key parameters to be transmitted to the medical team at a discontinuous rate (once a day for 4 weeks, then once a week for 20 weeks) via a brief questionnaire (smartphone application) and measurement sensors (weight, oxygen saturation, heart rate) linked to an interface, from the first day the patient returns home until the 6th month post-operatively. The values entered will be automatically compared with individualized standards established for each child at a multidisciplinary meeting, and any deviation from the standard will generate an alert. and the response of the medical teams will be protocolized. |
Who may qualify
- Ages
- 0 minutes to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Home monitoringThe key parameters (heart rate, arterial oxygen saturation, weight) will be measured at home using the measurement tools used by the parents, and tele-transmitted at a discontinuous rate, i.e. once a day for 4 weeks, then once a week for 20 weeks. The measurement tools will be given to the family before discharge from the hospital ward. These parameters will be entered into the Exolis platform, in addition to a very brief questionnaire designed to provide information about the child's diet, muscle tone and any medication he or she is taking. taken by the child. An alert will be automatically generated for the pediatric cardiology team if the data transmitted by the measurement sensors deviates from an individualized standard, defined for each child and/or each care pathway at the multidisciplinary consultation meeting before the child returns home. The response will be standardized on the basis of a protocol shared by the 4 investigating centers. | Other | home monitoring group |
| usual medical monitoringDuring the first 4 weeks: a weekly consultation including a record of intercurrent events (malaise, cyanosis, hyperthermia, eating difficulties), a record of weight and vital constants (oxygen saturation, heart rate), an examination of the sternotomy or thoracotomy scar, a clinical cardiovascular examination, a 12-lead electrocardiogram and a transthoracic echocardiogram. During the following 20 weeks: a consultation at 1, 3 and 6 months including the same assessment procedures. | Other | home monitoring group, standard group |
Primary outcome
Reducing postoperative morbidity and mortality
Time frame: 6th month post-op
The main objective is to evaluate the impact of home monitoring in reducing postoperative morbidity and mortality in patients aged 0 to 36 months who have undergone MCC.
11 secondary outcomes
Children's quality of life
Time frame: 0,1 month, 3 months and 6 months post op
Parents' quality of life
Time frame: 0,1 month, 3 months and 6 months post op
Parental stress
Time frame: 0,1 month, 3 months and 6 months post op
Children's weight growth
Time frame: 1 month, 3 months and 6 months post op
Post-traumatic stress syndromes
Time frame: 6 months post op
Serious non-cardiovascular events
Time frame: 6 months post op
Factors other than management
Time frame: 6 months post op
Therapeutic education program
Time frame: 6 months post op
Acceptability of monitoring for the parents
Time frame: 6 months post op
Acceptability of the monitoring for the medical teams
Time frame: 6 months post op
Efficiency
Time frame: 6 months post op
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 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home monitoring and usual medical monitoring in people with Congenital Heart Defect, run by Nantes University Hospital 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 12 inclusion and 0 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 25 Jun 2026. 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 Alban-Elouen Baruteau, Pr (+33 ext. +33240087742, albanelouen.baruteau@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing postoperative morbidity and mortality (time frame: 6th month post-op). 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 25 Jun 2026.