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Evaluation of the Effectiveness of the Cardiostory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea.

NCT07685106 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 850

Last updated 2026-07-06

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Eshmoun Clinical Research Center

    collaborator NETWORK

  • Sahloul Hospital of Sousse

    collaborator OTHER

  • University Hospital Monastir, Tunis

    collaborator OTHER

  • CardioStory INC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • Tunisia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07685106 on ClinicalTrials.gov