UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease

A vizsgálat adatai

Ki végzi

University of Minnesota

Azonosító

NCT07866573

A regiszteradat frissítve

2026. november 3.

Eredeti leírás

This pilot feasibility study will evaluate UltraTrac, an investigational noninvasive wearable device for continuous cardiac output monitoring, in patients with congenital heart disease.A teljes eredeti leírásKevesebb

UltraTrac for Noninvasive Cardiac Output Monitoring in Patients With Congenital Heart Disease: A Multi-Setting Pilot Feasibility Study

This pilot feasibility study will evaluate UltraTrac, an investigational noninvasive wearable device for continuous cardiac output monitoring, in patients with congenital heart disease.

UltraTrac integrates impedance cardiography and carotid Doppler ultrasound to estimate cardiac output. Participants undergoing clinically indicated cardiac catheterization, cardiac MRI, or cardiac intensive care unit monitoring will have UltraTrac measurements collected during routine clinical care.

UltraTrac measurements will be compared with reference standard or clinical hemodynamic measurements, including thermodilution, direct Fick method, cardiac magnetic resonance imaging-derived cardiac output, and clinical hemodynamic assessments before and after vasoactive medication changes. UltraTrac data will not be used to guide clinical decision-making.

Bevonási feltételek: 0-80 years old; Participant weight of at least 2 kg; Diagnosis of congenital heart disease of any anatomic type, including but not limited to repaired or unrepaired single ventricle physiology, biventricular congenital heart disease, valvular disease, septal defects, and conotruncal anomalies; Clinically indicated cardiac catheterization, cardiac MRI, or cardiac intensive care unit admission during the study enrollment period; For Arm 1: scheduled to undergo hemodynamic cardiac catheterization during which thermodilution and/or direct Fick cardiac output measurements will be performed as part of standard clinical care; For Arm 2: scheduled to undergo cardiac MRI during which CMR-derived cardiac output measurement will be obtained as part of the clinical protocol; For Arm 3: admitted to the cardiac intensive care unit and anticipated to require initiation or titration of vasoactive medication as part of standard clinical management; Parental permission, and assent when applicable, obtained from at least one parent or legally authorized representative.

Kizáró feltételek: Known allergy or prior skin reaction to adhesive electrodes or ultrasound gel; Known carotid artery abnormality, prior carotid surgery, or anatomic variant that would preclude reliable carotid Doppler signal acquisition; Skin breakdown, wound, or infection at any proposed electrode or probe placement site that would preclude safe device application; Hemodynamic instability at the time of enrollment that, in the judgment of the treating clinician, would preclude safe participation in research procedures; Participant or family refusal to participate or inability to obtain informed consent or parental permission; Pregnant women/persons; Fetuses; Prisoners; Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent; Employees of the researcher; Students of the researcher; Active members of the military or DoD personnel.

ClinicalTrials.gov NCT07866573