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

NCT07685106 | Recruiting FDA Device

• 1 other identifier: CS-HF_DYSP-2025
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 2

Brief 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

Heart Failure; Dyspnea

Keywords

dyspnea; Heart failure; non-cardiac causes of dyspnea; cardiostory; cardiac assessment device; cardiac causes of dyspnea

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance assessment of the CardioStory device.

  To assess the diagnostic performance of the CardioStory device in differentiating patients with heart failure from those with non-cardiac causes of dyspnea (including respiratory, metabolic etiologies) in patients presenting to the emergency department, using standard clinical assessments as the reference standard.

  Day 1

Secondary Outcomes (4)

• To evaluate the sensitivity and specificity of the CardioStory device for the diagnosis of heart failure.

  Day 1

• To compare the diagnostic results obtained with CardioStory device with reference diagnostic tools

  Day 1

• To evaluate the time required to obtain measurements using the CardioStory device compared with standard clinical assessments.

  Day 1

• To assess the adverse event occurrences of the CardioStory device in the emergency setting.

  Day 1

Study Arms (1)

Patients suffering from Dyspnea

Adult patients presenting to the emergency department with acute dyspnea.

Device: Non invasive cardiac assessment with the CardioStory device

Interventions

Non invasive cardiac assessment with the CardioStory device 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.

Patients suffering from Dyspnea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients presenting to the emergency department with acute or subacute dyspnea without an established diagnosis. This population represents patients requiring urgent evaluation to differentiate between cardiac and non-cardiac causes of dyspnea.

You may qualify if:

• Age ≥ 18 years
• Recent onset dyspnea (less than 7 days)
• Informed consent obtained

You may not qualify if:

• Age inferior to 18 years,
• Dyspnea clearly of traumatic or allergic origin

Sponsors & Collaborators

• CardioStory INC: lead
• University Hospital Monastir, Tunis: collaborator
• Eshmoun Clinical Research Center: collaborator
• Sahloul Hospital of Sousse: collaborator

Study Sites (2)

Fattouma bourguiba university hospital

Monastir, Monastir Governorate, 5000, Tunisia

RECRUITING

Sahloul university hospital

Sousse, 4054, Tunisia

RECRUITING

MeSH Terms

Conditions

Heart Failure; Dyspnea

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 6, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-07

Locations

TU (2)