Heart Defects, CongenitalHeart@HomeNCT06547268
Advancing the Science of Pediatric Interstage Home Monitoring
An observational study of Heart Defects, Congenital, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
The overall goal of this study is to understand the feasibility of using a wireless sensor device (instead of a wired device) to collect information used to monitor children with heart conditions at home. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- Wireless sensor and platform
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2024to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Children receiving remote patient monitoring in tele-interstage home monitoring program.
Who may be able to join
- Receiving active remote patient monitoring (RPM) in Lurie's Tele-Interstage Home Monitoring Program.
- Age 0-2 years of age at enrollment.
- In the opinion of the investigator, parent or legally authorized guardian, and participant, the participant and (when relevant) family can follow study procedures.
Who cannot join
- Is going to discontinue RPM before their enrollment would end (i.e., within 14 days).
- Skin breakdown or severe rash at the site of sensor placement.
- Patient without a parental guardian to consent.
- The patient is in active hospice or similar end-of-life care.
- The patient will be living in a long-term institution or transitional facility.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Heart@Home: Advancing the Science of Pediatric Interstage Home Monitoring
The overall goal of this study is to understand the feasibility of using a wireless sensor device (instead of a wired device) to collect information used to monitor children with heart conditions at home.
Read the detailed description
The goal of this study is to examine how well continuous sensor-based monitoring performs at detecting physiologic data in infants with single ventricle physiology at home compared to existing approaches, in manner that is feasible and acceptable to patients' families. Performance features of interest include how the data compares to family measurements, whether it correlates with parents' observable symptoms, and how this approach may be integrated into home life and health system workflows. The investigators will also explore whether the collected data can be used to develop predictive analytics for acute deterioration and/or advanced chronic cardiopulmonary management compared to what is currently being done in remote patient monitoring.
- Conditions
- Heart Defects, Congenital
- Being tested
- Wireless sensor and platform
- Keywords
- Heart Defects, Congenital, Digital Health
- 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.
Wireless sensor and platformDevice
Also called Arc
Skin-mounted sensor that pairs with tablet platform
| Study group | Role | What they receive |
|---|---|---|
| Home monitoring program patients | Patients enrolled in the study are those patients who are already enrolled in (or are being discharged with) home monitoring in an existing program Receives: Device: Wireless sensor and platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologic measurements
Physiologic data waveform morphology
Measured: up to 14 days per patient of data collection
Secondary outcomes (2)
Systems Usability Score
Score from 0 (min) to 100 (max) of usability with higher is better (100=perfect).
Measured: up to 14 days per patient of data collection
Utilization
Emergency departnment use
Measured: up to 14 days per patient of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start24 Jul 2024
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Why it stopped: Changes to sensor to test
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Defects, CongenitalStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Sibel Health Inc.
- Responsible party
- Principal investigator, Carolyn Foster, Northwestern University
- Investigators
- Carolyn C Foster, MD, MS, Principal investigator, Ann and Robert H. Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547268
- Sponsor's protocol ID
- 2023-6397
- Acronym
- Heart@Home
- Status last verified
- Oct 2025
- First submitted
- 7 Aug 2024
- Last updated
- 31 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data requests will be reviewed by PI if the occur.
Publications
Foster C, Schinasi D, Kan K, Macy M, Wheeler D, Curfman A. Remote Monitoring of Patient- and Family-Generated Health Data in Pediatrics. Pediatrics. 2022 Feb 1;149(2):e2021054137. doi: 10.1542/peds.2021-054137.
PubMed 35102417Foster CC, Steltzer M, Snyder A, Alden C, Helner K, Schinasi DA, Bohling K, Allen K. Integrated Multimodality Telemedicine to Enhance In-Home Care of Infants During the Interstage Period. Pediatr Cardiol. 2021 Feb;42(2):349-360. doi: 10.1007/s00246-020-02489-7. Epub 2020 Oct 20.
PubMed 33079264Rudd NA, Ghanayem NS, Hill GD, Lambert LM, Mussatto KA, Nieves JA, Robinson S, Shirali G, Steltzer MM, Uzark K, Pike NA; American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Lifelong Congenital Heart Disease and Heart Health in the Young; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Clinical Cardiology; and Council on Lifestyle and Cardiometabolic Health. Interstage Home Monitoring for Infants With Single Ventricle Heart Disease: Education and Management: A Scientific Statement From the American Heart Association. J Am Heart Assoc. 2020 Aug 18;9(16):e014548. doi: 10.1161/JAHA.119.014548. Epub 2020 Aug 11.
PubMed 32777961
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart@Home: Advancing the Science of Pediatric Interstage Home Monitoring
- ClinicalTrials.gov ID
- NCT06547268
- Acronym / sponsor ID
- Heart@Home / 2023-6397
- Conditions
- Heart Defects, Congenital
- Keywords
- Heart Defects, Congenital, Digital Health
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Changes to sensor to test
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Sibel Health Inc.
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 9 Aug 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.
The overall goal of this study is to understand the feasibility of using a wireless sensor device (instead of a wired device) to collect information used to monitor children with heart conditions at home.
Detailed description
The goal of this study is to examine how well continuous sensor-based monitoring performs at detecting physiologic data in infants with single ventricle physiology at home compared to existing approaches, in manner that is feasible and acceptable to patients' families. Performance features of interest include how the data compares to family measurements, whether it correlates with parents' observable symptoms, and how this approach may be integrated into home life and health system workflows. The investigators will also explore whether the collected data can be used to develop predictive analytics for acute deterioration and/or advanced chronic cardiopulmonary management compared to what is currently being done in remote patient monitoring.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home monitoring program patients | – | Device: Wireless sensor and platformPatients enrolled in the study are those patients who are already enrolled in (or are being discharged with) home monitoring in an existing program |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children receiving remote patient monitoring in tele-interstage home monitoring program.
Key inclusion criteria (3 listed)
- Receiving active remote patient monitoring (RPM) in Lurie's Tele-Interstage Home Monitoring Program.
- Age 0-2 years of age at enrollment.
- In the opinion of the investigator, parent or legally authorized guardian, and participant, the participant and (when relevant) family can follow study procedures.
Key exclusion criteria (5 listed)
- Is going to discontinue RPM before their enrollment would end (i.e., within 14 days).
- Skin breakdown or severe rash at the site of sensor placement.
- Patient without a parental guardian to consent.
- The patient is in active hospice or similar end-of-life care.
- The patient will be living in a long-term institution or transitional facility.
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 |
|---|---|---|
| Wireless sensor and platformAlso: ArcSkin-mounted sensor that pairs with tablet platform | Device | Home monitoring program patients |
Primary outcome
Physiologic measurements
Time frame: up to 14 days per patient of data collection
Physiologic data waveform morphology
2 secondary outcomes
Systems Usability Score
Time frame: up to 14 days per patient of data collection
Utilization
Time frame: up to 14 days per patient of data collection
Results and safety
The study was stopped early (reason given: Changes to sensor to test). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Background: PubMed 35102417Foster C, Schinasi D, Kan K, Macy M, Wheeler D, Curfman A. Remote Monitoring of Patient- and Family-Generated Health Data in Pediatrics. Pediatrics. 2022 Feb 1;149(2):e2021054137. doi: 10.1542/peds.2021-054137.
- Background: PubMed 33079264Foster CC, Steltzer M, Snyder A, Alden C, Helner K, Schinasi DA, Bohling K, Allen K. Integrated Multimodality Telemedicine to Enhance In-Home Care of Infants During the Interstage Period. Pediatr Cardiol. 2021 Feb;42(2):349-360. doi: 10.1007/s00246-020-02489-7. Epub 2020 Oct 20.
- Background: PubMed 32777961Rudd NA, Ghanayem NS, Hill GD, Lambert LM, Mussatto KA, Nieves JA, Robinson S, Shirali G, Steltzer MM, Uzark K, Pike NA; American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Lifelong Congenital Heart Disease and Heart Health in the Young; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Clinical Cardiology; and Council on Lifestyle and Cardiometabolic Health. Interstage Home Monitoring for Infants With Single Ventricle Heart Disease: Education and Management: A Scientific Statement From the American Heart Association. J Am Heart Assoc. 2020 Aug 18;9(16):e014548. doi: 10.1161/JAHA.119.014548. Epub 2020 Aug 11.
- Individual participant dataSharing planned: No. Data requests will be reviewed by PI if the occur.
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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. This study is not recruiting at the moment.
Carolyn C Foster, MD, MS principal investigator
Ann and Robert H. Lurie Children's Hospital of Chicago
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 Defects, Congenital, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 31 Oct 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 United States. 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?
The study was stopped early (reason given: Changes to sensor to test). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiologic measurements (time frame: up to 14 days per patient of data collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06547268, which also lists 3 linked publications.
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 31 Oct 2025.