Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT06969560
Eligibility Criteria:
Inclusion Criteria:
* Patients from 8-18 years of age who are outpatients at time of study enrollment.
* Patients with a chest size of at least 69.85 cm in perimeter/circumference (as measured under the pectoral muscles)
* Patients at-risk for heart failure and with American Heart Association (AHA) Stage B-D Heart Failure will be included in this study irrespective of heart failure medication use.
* HF etiologies include: congenital cardiac malformation with systemic ventricular systolic dysfunction, idiopathic cardiomyopathy, familial/inherited and/or genetic cardiomyopathy, history of myocarditis with persistent ventricular dysfunction, neuromuscular disorder, inborn error of metabolism, mitochondrial disorder, acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional), ischemic (e.g., Kawasaki disease and post-operative HF), and left ventricular non-compaction, restrictive cardiomyopathy and HCM with systolic or diastolic dysfunction.
Exclusion Criteria:
* Patients within 3 months of a surgery.
* Patients supported by ventricular assist device at study onset.
* Inability to use technology due to physical or cognitive impairment in the patient or caregiver.
* Non-English speaking.
* Patients who have an implantable cardiac defibrillator or pacemaker
* Patients whose chest size is too large or small to fit available sizes of the Skiin device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT06969560
Study Brief:
Protocol Section:
NCT06969560