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Evaluation of the Effectiveness of the Cardiostory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea.
Sponsor: CardioStory INC
Summary
This is a prospective, observational study conducted in the emergency department. Adult patients presenting with dyspnea will be enrolled, and study data will be collected from routine clinical assessments, including medical history, physical examination, laboratory tests, and echocardiography results, as well as non-invasive cardiovascular measurements obtained using the CardioStory device.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
850
Start Date
2025-09-01
Completion Date
2026-12
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
Non invasive cardiac assessment with the CardioStory device
The CardioStory device, is a non-invasive medical technology designed to rapidly (approximately 2 minutes) assess cardiac filling pressure in patients with suspected or established heart failure. It uses proprietary fiber-optic sensors combined with advanced signal processing and analytical algorithms to detect and analyze physiological signals related to cardiac mechanical function. These signals are processed to generate a quantitative estimate of cardiac filling pressure without the need for catheterization, contrast agents, or injectable substances. The measurement is performed non-invasively and is designed to be simple, rapid, and reproducible.
Locations (2)
Fattouma bourguiba university hospital
Monastir, Monastir Governorate, Tunisia
Sahloul university hospital
Sousse, Tunisia