Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-04 @ 4:44 AM
Study NCT ID:
NCT06547268
Status:
TERMINATED
Last Update Posted:
2025-10-31
First Post:
2024-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advancing the Science of Pediatric Interstage Home Monitoring
Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Organization:
Study Overview
Official Title:
Heart@Home: Advancing the Science of Pediatric Interstage Home Monitoring
Status:
TERMINATED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Changes to sensor to test
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Heart@Home
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: